search
Back to results

Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases (ExeHeart)

Primary Purpose

Spondyloarthritis, Rheumatoid Arthritis, Psoriatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High-intensity exercise (HIIT)
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring Exercise, Cardiovascular disease, Cardiovascular risk, High-intensity training, Physiotherapy, High-intensity exercise, Inflammatory joint disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 18-70
  • BMI: 18.5-40
  • Inflammatory joint disease verified by physician
  • Able to walk unaided and continuously for ≥ 15 min.
  • Norwegian or English speaking

Exclusion Criteria:

  • Sustained lower extremity injury ≤12 months, including surgery
  • Neurological disease
  • Absolute contraindication to maximal exercise test
  • Cognitive impairment
  • Participation in structured high-intensity exercise ≥ 1/week in the last 3 months

Sites / Locations

  • Diakonhjemmet Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High-intensity exercise (HIIT)

Usual care

Arm Description

Usual care; CVD risk assessment, lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication. The 12-week intervention is carried out as individual or group sessions with maximal 4 patients, supervised by physiotherapists in primary health care. The HIIT group complete two weekly HIIT sessions and a third weekly session with exercise at moderate intensity. Exercise is tailored to each individual to provide the same relative exercise stress and to ensure progression. Target exercise intensity is tracked by a heart rate monitor. Individual exercise session are recorded in a training diary. Succeeding the intervention, a questionnaire will be distributed to patients in the HIIT group. Semi-structured interviews will target physiotherapists supervising HIIT and 5-7 patients in the HIIT group.

Control group participants receive the same treatment as usual care; CVD risk assessment including lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication. Control group participants are invited to a physiotherapist-led theoretical and practical HIIT session following study completion.

Outcomes

Primary Outcome Measures

Peak oxygen uptake - VO2peak ml/kg/min
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion

Secondary Outcome Measures

Peak oxygen uptake - VO2peak L/min
VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Peak oxygen uptake - VO2peak ml/kg/min
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Peak oxygen uptake - VO2peak ml/kg/min
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Peak oxygen uptake - VO2peak L/min
VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Peak oxygen uptake - VO2peak L/min
VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Change in VO2peak (ml/kg/min) from baseline to 3 months past baseline
Change in VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute from baseline to 6 months (3 months post intervention) . VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Change in VO2peak (ml/kg/min) from baseline to 6 months post baseline
Change in VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute from baseline to 6 months (3 months post intervention) . VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Change in VO2peak L/min from baseline to 3 months post baseline
VO2peak, expressed in liters per minute(L/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Change in VO2peak L/min from baseline to 6 months post baseline
VO2peak, expressed in liters per minute(L/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Body composition
Body scan to estimate total and regional distribution of lean body mass and fat mass
Body composition
Body scan to estimate total and regional distribution of lean body mass and fat mass
Body composition
Body scan to estimate total and regional distribution of lean body mass and fat mass
Ventilatory threshold 1
Point during at which ventilation starts to increase at a faster rate than VO2 - derived from CPET
Ventilatory threshold 1
Point during exercise at which ventilation starts to increase at a faster rate than VO2 - derived from CPET
Ventilatory threshold 1
Point during exercise at which ventilation starts to increase at a faster rate than volume of oxygen (VO2) - derived from CPET
Ventilatory threshold 2
The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET
Ventilatory threshold 2
The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET
Ventilatory threshold 2
The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET
Breathing reserve
Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET
Breathing reserve
Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET
Breathing reserve
Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET
Oxygen pulse
The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.
Oxygen pulse
The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.
Oxygen pulse
The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.
Ventilatory equivalents for oxygen (VE/VO2)
Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET
Ventilatory equivalents for oxygen (VE/VO2)
Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET
Ventilatory equivalents for oxygen (VE/VO2)
Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET
Ventilatory equivalents for carbon dioxide(VE/VCO2)
Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET
Ventilatory equivalents for carbon dioxide(VE/VCO2)
Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET
Ventilatory equivalents for carbon dioxide (VE/VCO2)
Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET
Respiratory Exchange Ratio (RER)
Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET
Respiratory Exchange Ratio (RER)
Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET
Respiratory Exchange Ratio (RER)
Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET
Blood lactate concentration
Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes
Blood lactate concentration
Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes
Blood lactate concentration
Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes
C-Reactive protein
Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein
C-Reactive protein
Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein
C-Reactive protein
Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein
Erythrocyte Sedimentation Rate
Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate
Erythrocyte Sedimentation Rate
Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate
Erythrocyte Sedimentation Rate
Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate
Total cholesterol
Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol
Total cholesterol
Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol
Total cholesterol
Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol
High-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins
High-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins
High-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins
Low-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins
Low-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins
Low-density lipoproteins
Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins
Triglycerides
Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides
Triglycerides
Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides
Triglycerides
Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides
Blood pressure
Supine systolic and diastolic blood pressure
Blood pressure
Supine systolic and diastolic blood pressure
Blood pressure
Supine systolic and diastolic blood pressure
Body Mass Index
Weight in kilograms divided by the square of height in meters
Body Mass Index
Weight in kilograms divided by the square of height in meters
Body Mass Index
Weight in kilograms divided by the square of height in meters
Waist circumference
Waist girth in centimeters. Measured in a standing position after a full exhale.
Waist circumference
Waist girth in centimeters. Measured in a standing position after a full exhale.
Waist circumference
Waist girth in centimeters. Measured in a standing position after a full exhale.
Resting heart rate
Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench
Resting heart rate
Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench
Resting heart rate
Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench
Health-related quality of life, EuroQoL (EQ5D-5L)
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Health-related quality of life, EuroQoL (EQ5D-5L)
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Health-related quality of life, EuroQoL (EQ5D-5L)
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Frequency of medication
Usage of medications last three months. Measured in frequency.
Dosage of medication
Usage of medications last three months. Measured in dosage.
Dosage of medication
Usage of medications last three months. Measured in dosage
Frequency of medication
Usage of medications last three months. Measured in frequency
Dosage of medication
Usage of medications last three months. Measured in dosage.
Frequency of medication
Usage of medications last three months. Measured in frequency.
Self-reported fatigue
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Self-reported fatigue
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Self-reported fatigue
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Self-reported pain
Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Self-reported pain
Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Self-reported pain
Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Self-reported physical activity (HUNT)
Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
Self-reported physical activity (HUNT)
Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
Self-reported physical activity (HUNT)
Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
SCORE2
Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.
SCORE2
Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.
SCORE2
Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.
Forced vital capacity
Volume of air that can be forcefully exhaled after a full inspiration, measured in liters. Obtained from spirometry
Forced vital capacity
Volume of air that can be forcefully exhaled after a full inspiration, measured in liters- obtained from spirometry
Forced vital capacity
Volume of air that can be forcefully exhaled after a full inspiration, measured in liters- obtained from spirometry
Forced expiratory volume in 1 second (FEV1)
Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry
Forced expiratory volume in 1 second (FEV1)
Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry
Forced expiratory volume in 1 second (FEV1)
Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry
FEV1/FVC ratio
Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)
FEV1/FVC ratio
Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)
FEV1/FVC ratio
Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)
Forced expiratory flow
Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry
Forced expiratory flow
Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry
Forced expiratory flow
Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry
Peak expiratory flow (PEF)
Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry
Peak expiratory flow (PEF)
Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry
Peak expiratory flow (PEF)
Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry
Maximum voluntary ventilation (MVV)
Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry
Maximum voluntary ventilation (MVV)
Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry
Maximum voluntary ventilation (MVV)
Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry
Psoriatic Arthritis Impact of Disease (PsAID)
Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with psoriatic arthritis.
Psoriatic Arthritis Impact of Disease (PsAID)
Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants psoriatic arthritis.
Psoriatic Arthritis Impact of Disease (PsAID)
Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with psoriatic arthritis.
Rheumatoid arthritis impact of disease (RAID)
Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.
Rheumatoid arthritis impact of disease (RAID)
Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.
Rheumatoid arthritis impact of disease (RAID)
Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Bath Ankylosing Spondylitis Functional Index (BASFI)
Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Bath Ankylosing Spondylitis Functional Index (BASFI)
Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Bath Ankylosing Spondylitis Functional Index (BASFI)
Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Bath Ankylosing Spondylitis Global Score (BAS-G)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Bath Ankylosing Spondylitis Global Score (BAS-G)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Bath Ankylosing Spondylitis Global Score (BAS-G)
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)
Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)
Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)
Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.
Disease Activity in PSoriatic Arthritis (DAPSA)
Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis
Disease Activity in PSoriatic Arthritis (DAPSA)
Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis
Disease Activity in PSoriatic Arthritis (DAPSA)
Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis
Post-exercise questionnaire
Electronic questionnaire distributed to patients in the experimental group upon completion of HIT intervention. 14 statements related to participation in the HIT exercise intervention and perceived intensity, duration and frequency of the exercise intervention. Scored on a 5 point Likert scale ranging from strongly disagree to strongly agree.
Use of healthcare services
Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.
Use of healthcare services
Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.
Use of healthcare services
Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.
Smoking status
Registered by self-report; I smoke daily, I am a former smoker , I have never smoked
Smoking status
Registered by self-report; I smoke daily, I am a former smoker , I have never smoked
Smoking status
Registered by self-report; I smoke daily, I am a former smoker , I have never smoked
Snuff status
Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff
Snuff status
Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff
Snuff status
Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff
Peak heart rate
Peak heart rate observed during CPET
Peak heart rate
Peak heart rate observed during CPET
Peak heart rate
Peak heart rate observed during CPET
Augmentation index
Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure
Augmentation index
Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure
Augmentation index
Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure
Pulse Wave Velocity
Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure
Pulse Wave Velocity
Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure
Pulse Wave Velocity
Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure
Exercise self-efficacy
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Exercise self-efficacy
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Exercise self-efficacy
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Exercise frequency
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise frequency is recorded.
Exercise intensity
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise intensity is recorded by use of a herat rate monitor.
Exercise duration
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise duration is recorded.
Early session termination
Participants in the experimental group are asked to record individual exercise session in a training diary. Early session termination is recorded.
Exercise-related adverse events
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise-related adverse events are recorded.
Self-reported cardiovascular health and symptoms
13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided
Self-reported cardiovascular health and symptoms
13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided
Self-reported cardiovascular health and symptoms
13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided
Self-report change in physical fitness
Patient global change in self-perceived physical fitness measured on a 5-point Likert scale ranging from much better to much worse
Self-report change in physical fitness
Patient global change in self-perceived physical fitness measured on a 5-point Likert scale ranging from much better to much worse
Self-report exercise habits
Questionnaire; self-report of exercise habits from baseline to 3 months post baseline: Participation in regular exercise (yes/no), if yes: frequency (1-2 times/week, 3-4 times/week, 5 times or more/week) and mode of exercise (endurance exercise, strength exercise, mobility exercise and/or other). These questions are only forwarded to participants in the control group at this timepoint. Exercise habits form baseline to 3 months post baseline is recorded via the training diary for participants allocated to HIIT (experimental group): see outcome 153-157.
Self-report exercise habits
Questionnaire; self-report of exercise habits from 3 months post baseline to 6 months post-baseline: Participation in regular exercise (yes/no), if yes: frequency (1-2 times/week, 3-4 times/week, 5 times or more/week) and mode of exercise (endurance exercise, strength exercise, mobility exercise and/or other). These questions are forwarded to all study participants at this timepoint.
Corona virus 19 infection
Questionnaire; self-report regarding corona virus 19 infection (yes/no, if yes: hospitalization/no hospitalization) from baseline to 3 months post baseline
Corona virus 19 infection
Questionnaire; self-report regarding corona virus 19 infection (yes/no, if yes: hospitalization/no hospitalization) from 3 months post baseline to 6 montsh post baseline
Corona virus 19 quarantine
Questionnaire; self-report regarding corona virus 19 quarantine (yes/no) from baseline to 3 months post baseline
Corona virus 19 quarantine
Questionnaire; self-report regarding corona virus 19 quarantine (yes/no) from 3 months post baseline to 6 months post baseline
Maximum minute ventilation at peak exercise (VEmax, L/min)
Maximum ventilation, recorded from CPET at peak exercise
Maximum minute ventilation at peak exercise (VEmax, L/min)
Maximum ventilation, recorded from CPET at peak exercise
Maximum minute ventilation at peak exercise (VEmax, L/min)
Maximum ventilation, recorded from CPET at peak exercise

Full Information

First Posted
May 15, 2021
Last Updated
March 10, 2023
Sponsor
Diakonhjemmet Hospital
Collaborators
The Dam Foundation, The Norwegian Rheumatism Association, Norwegian Health Association
search

1. Study Identification

Unique Protocol Identification Number
NCT04922840
Brief Title
Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases
Acronym
ExeHeart
Official Title
Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital
Collaborators
The Dam Foundation, The Norwegian Rheumatism Association, Norwegian Health Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Inflammatory joint diseases (IJD) are autoimmune diseases with common symptoms of joint inflammation, pain, stiffness and fatigue. Compared to the general population, this large patient-group has an increased risk of cardiovascular disease (CVD) and CVD-related mortality. Patients with IJD call for improved CVD screening and risk management as well as access to evidence-based non-pharmacological treatment alternatives. Evidence supports high intensity training (HIIT) in mitigating risk of CVD and inflammation, but the evidence of these cardioprotective benefits is unclear in patients with IJD and the feasibility of HIIT protocols in daily clinical care needs to be addressed. Cardiorespiratory fitness (CRF) is an important physiological marker and highly correlated to risk of CVD. Despite strong recommendations, routine assessment of CRF is seldom performed in clinical care. The ExeHeart study will assess the potential cardioprotective and disease-modifying effect of HIIT in IJD in a randomized controlled trial. Furthermore, the ExeHeart-study will report on the validity of non-exercise measures of cardiorespiratory fitness (eCRF) measures for use in daily clinical care. Additionally, we will explore the feasibility of HIIT by addressing adherence and fidelity to the HIIT treatment protocol in a primary care setting
Detailed Description
The study is a two-armed randomized controlled trial (RCT). Patients aged 18-70 years presenting with inflammatory joint disease at the Preventive Cardio-Rheuma clinic at Diakonhjemmet hospital (Oslo) will be included if eligible for the study. Succeeding baseline testing, participants are randomized to either experimental group (high-intensity exercise-HIIT) or control group (usual care). The research questions are: Is a 12-week HIIT program effective on VO2peak, inflammatory markers and risk of cardiovascular disease in patients with inflammatory joint disease and what is the association between VO2peak and disease-specific and cardiovascular disease-related variables? Is a non-exercise cardio-respiratory fitness algorithm (eCRF) valid in determining longitudinal change in VO2peak in patients with inflammatory joint disease? How feasible is a HIIT intervention in primary care in patients with inflammatory joint disease in terms of adherence and fidelity to the exercise program? The primary analysis will be a between group comparison of VO2peak levels. This will be carried out according to the intention-to-treat principle, and done by the analysis of covariance (ANCOVA), adjusting for VO2peak values at baseline along with stratification factors used in the randomization. Secondary analyses will include between group comparisons on secondary endpoints, as well as comparisons in the per protocol population. No adjustment for multiple testing will be done. The association between VO2peak and changes in inflammatory markers, disease activity and CVD risk will be assessed using multiple regression. The validity of eCRF models to accurately detect longitudinal change in VO2peak from baseline to 3-month and 6-month follow-up will be assessed with Pearson or Spearman correlation by comparing VO2peak derived from a cardiopulmonary exercise test to eCRF. The feasibility of a HIIT program and adherence will be examined with descriptive statistics. Adherence to the prescribed HIIT intervention will be recorded by attendance to exercise sessions. Quality of treatment delivery will be quantified as the number of exercise sessions complying with the planned exercise intensity and number of exercise sessions requiring dose modifications such as lower exercise intensity or early session termination. At the 3-month timepoint, an electronic questionnaire will be distributed to patients in the HIIT group. Questions regarding feasibility and implementation fidelity will address patients' acceptability and satisfaction with the HIIT program. The ExeHeart study will also include semi-structured interviews, targeting physiotherapists in charge of supervising the exercise sessions and 5-7 patients in the intervention group. The interviews will explore barriers and facilitators in exercise adherence, experience with the protocol and perceived effects of exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis, Rheumatoid Arthritis, Psoriatic Arthritis
Keywords
Exercise, Cardiovascular disease, Cardiovascular risk, High-intensity training, Physiotherapy, High-intensity exercise, Inflammatory joint disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be allocated 1:1 according to a computer-generated randomization scheme, stratified by sex
Masking
Investigator
Masking Description
The trial is single-blinded with investigator (KRN) masked for group allocation to reduce risk of bias. Patients are not blinded to treatment exposure nor study hypothesis.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity exercise (HIIT)
Arm Type
Experimental
Arm Description
Usual care; CVD risk assessment, lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication. The 12-week intervention is carried out as individual or group sessions with maximal 4 patients, supervised by physiotherapists in primary health care. The HIIT group complete two weekly HIIT sessions and a third weekly session with exercise at moderate intensity. Exercise is tailored to each individual to provide the same relative exercise stress and to ensure progression. Target exercise intensity is tracked by a heart rate monitor. Individual exercise session are recorded in a training diary. Succeeding the intervention, a questionnaire will be distributed to patients in the HIIT group. Semi-structured interviews will target physiotherapists supervising HIIT and 5-7 patients in the HIIT group.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Control group participants receive the same treatment as usual care; CVD risk assessment including lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication. Control group participants are invited to a physiotherapist-led theoretical and practical HIIT session following study completion.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity exercise (HIIT)
Intervention Description
12 week intervention: Two weekly sessions of 35-40 min exercise: 10 min warm-up, followed by 4x4 min at 90-95% peak heart rate (HRpeak) interspaced by 2-3 min active breaks at 60-70% HRpeak and a third weekly session with continuous exercise for a minimum of 40 min at moderate intensity.
Primary Outcome Measure Information:
Title
Peak oxygen uptake - VO2peak ml/kg/min
Description
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Time Frame
3 months post baseline
Secondary Outcome Measure Information:
Title
Peak oxygen uptake - VO2peak L/min
Description
VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Time Frame
3 months post baseline
Title
Peak oxygen uptake - VO2peak ml/kg/min
Description
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Time Frame
Baseline
Title
Peak oxygen uptake - VO2peak ml/kg/min
Description
VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Time Frame
6 months post baseline
Title
Peak oxygen uptake - VO2peak L/min
Description
VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Time Frame
Baseline
Title
Peak oxygen uptake - VO2peak L/min
Description
VO2peak, expressed in liters per minute. VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion (RPE 0-10)
Time Frame
6 months post baseline
Title
Change in VO2peak (ml/kg/min) from baseline to 3 months past baseline
Description
Change in VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute from baseline to 6 months (3 months post intervention) . VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Time Frame
3 months post baseline
Title
Change in VO2peak (ml/kg/min) from baseline to 6 months post baseline
Description
Change in VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute from baseline to 6 months (3 months post intervention) . VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Time Frame
6 months
Title
Change in VO2peak L/min from baseline to 3 months post baseline
Description
VO2peak, expressed in liters per minute(L/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Time Frame
3 months post baseline
Title
Change in VO2peak L/min from baseline to 6 months post baseline
Description
VO2peak, expressed in liters per minute(L/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion
Time Frame
6 months post baseline
Title
Body composition
Description
Body scan to estimate total and regional distribution of lean body mass and fat mass
Time Frame
Baseline
Title
Body composition
Description
Body scan to estimate total and regional distribution of lean body mass and fat mass
Time Frame
3 months post baseline
Title
Body composition
Description
Body scan to estimate total and regional distribution of lean body mass and fat mass
Time Frame
6 months post baseline
Title
Ventilatory threshold 1
Description
Point during at which ventilation starts to increase at a faster rate than VO2 - derived from CPET
Time Frame
Baseline
Title
Ventilatory threshold 1
Description
Point during exercise at which ventilation starts to increase at a faster rate than VO2 - derived from CPET
Time Frame
3 months post baseline
Title
Ventilatory threshold 1
Description
Point during exercise at which ventilation starts to increase at a faster rate than volume of oxygen (VO2) - derived from CPET
Time Frame
6 months post baseline
Title
Ventilatory threshold 2
Description
The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET
Time Frame
Baseline
Title
Ventilatory threshold 2
Description
The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET
Time Frame
3 months post baseline
Title
Ventilatory threshold 2
Description
The point at which the oxygen demand of the muscles exceeds the ability of the cardiopulmonary system to supply oxygen- derived from CPET
Time Frame
6 months post baseline
Title
Breathing reserve
Description
Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET
Time Frame
Baseline
Title
Breathing reserve
Description
Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET
Time Frame
3 months post baseline
Title
Breathing reserve
Description
Difference between the maximal voluntary ventilation (MVV) and the maximum ventilation measured during CPET
Time Frame
6 months post baseline
Title
Oxygen pulse
Description
The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.
Time Frame
Baseline
Title
Oxygen pulse
Description
The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.
Time Frame
3 months post baseline
Title
Oxygen pulse
Description
The oxygen pulse is the oxygen (O2) divided by heart rate, and represents the product of the stroke volume and the arterial-venous oxygen difference. Derived from CPET.
Time Frame
6 months post baseline
Title
Ventilatory equivalents for oxygen (VE/VO2)
Description
Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET
Time Frame
Baseline
Title
Ventilatory equivalents for oxygen (VE/VO2)
Description
Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET
Time Frame
3 months post baseline
Title
Ventilatory equivalents for oxygen (VE/VO2)
Description
Ratio of the volume of gas expired per minute to the volume of oxygen consumed per minute- derived from CPET
Time Frame
6 months post baseline
Title
Ventilatory equivalents for carbon dioxide(VE/VCO2)
Description
Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET
Time Frame
Baseline
Title
Ventilatory equivalents for carbon dioxide(VE/VCO2)
Description
Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET
Time Frame
3 months post baseline
Title
Ventilatory equivalents for carbon dioxide (VE/VCO2)
Description
Ratio of the volume of gas expired per minute to the volume of carbon dioxide produced per minute- derived from CPET
Time Frame
6 months post baseline
Title
Respiratory Exchange Ratio (RER)
Description
Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET
Time Frame
Baseline
Title
Respiratory Exchange Ratio (RER)
Description
Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET
Time Frame
3 months post baseline
Title
Respiratory Exchange Ratio (RER)
Description
Ratio of carbon dioxide output/oxygen uptake (VCO2/VO2) at peak exercise intensity - derived from CPET
Time Frame
6 months post baseline
Title
Blood lactate concentration
Description
Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes
Time Frame
Baseline
Title
Blood lactate concentration
Description
Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes
Time Frame
3 months post baseline
Title
Blood lactate concentration
Description
Sampled from fingertip within 60 sec of CPET completion to assess level of anaerobic processes
Time Frame
6 months post baseline
Title
C-Reactive protein
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein
Time Frame
Baseline
Title
C-Reactive protein
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein
Time Frame
3 months post baseline
Title
C-Reactive protein
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for C-Reactive protein
Time Frame
6 months post baseline
Title
Erythrocyte Sedimentation Rate
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate
Time Frame
Baseline
Title
Erythrocyte Sedimentation Rate
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate
Time Frame
3 months post baseline
Title
Erythrocyte Sedimentation Rate
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for Erythrocyte Sedimentation Rate
Time Frame
6 months post baseline
Title
Total cholesterol
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol
Time Frame
Baseline
Title
Total cholesterol
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol
Time Frame
3 months post baseline
Title
Total cholesterol
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for total cholesterol
Time Frame
6 months post baseline
Title
High-density lipoproteins
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins
Time Frame
Baseline
Title
High-density lipoproteins
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins
Time Frame
3 months post baseline
Title
High-density lipoproteins
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for high-density lipoproteins
Time Frame
6 months post baseline
Title
Low-density lipoproteins
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins
Time Frame
Baseline
Title
Low-density lipoproteins
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins
Time Frame
3 months post baseline
Title
Low-density lipoproteins
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for low-density lipoproteins
Time Frame
6 months post baseline
Title
Triglycerides
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides
Time Frame
Baseline
Title
Triglycerides
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides
Time Frame
3 months post baseline
Title
Triglycerides
Description
Non-fasting blood samples are measured at the hospital laboratory and analysed for triglycerides
Time Frame
6 months post baseline
Title
Blood pressure
Description
Supine systolic and diastolic blood pressure
Time Frame
Baseline
Title
Blood pressure
Description
Supine systolic and diastolic blood pressure
Time Frame
3 months post baseline
Title
Blood pressure
Description
Supine systolic and diastolic blood pressure
Time Frame
6 months post baseline
Title
Body Mass Index
Description
Weight in kilograms divided by the square of height in meters
Time Frame
Baseline
Title
Body Mass Index
Description
Weight in kilograms divided by the square of height in meters
Time Frame
3 months post baseline
Title
Body Mass Index
Description
Weight in kilograms divided by the square of height in meters
Time Frame
6 months post baseline
Title
Waist circumference
Description
Waist girth in centimeters. Measured in a standing position after a full exhale.
Time Frame
Baseline
Title
Waist circumference
Description
Waist girth in centimeters. Measured in a standing position after a full exhale.
Time Frame
3 months post baseline
Title
Waist circumference
Description
Waist girth in centimeters. Measured in a standing position after a full exhale.
Time Frame
6 months post baseline
Title
Resting heart rate
Description
Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench
Time Frame
Baseline
Title
Resting heart rate
Description
Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench
Time Frame
3 months post baseline
Title
Resting heart rate
Description
Recorded in conjunction with blood pressure measurement at rest- resting supine on a bench
Time Frame
6 months post baseline
Title
Health-related quality of life, EuroQoL (EQ5D-5L)
Description
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Time Frame
Baseline
Title
Health-related quality of life, EuroQoL (EQ5D-5L)
Description
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Time Frame
3 months post baseline
Title
Health-related quality of life, EuroQoL (EQ5D-5L)
Description
Health-related quality of life is measured by the EQ5D-5L questionnaire. Patients are asked to answer their ability to perform walking, personal care and activities of daily life on a 5 point Likert scale from no difficulties to not able to. Pain and anxiety/depression is measured on a 5 point Likert scale from no pain to very strong pain, and no anxiety/depression to extremely anxious/depressed. General experience of health is measured from 0 (worst health) to 100 (best health) on a numeric rating scale.
Time Frame
6 months post baseline
Title
Frequency of medication
Description
Usage of medications last three months. Measured in frequency.
Time Frame
Baseline
Title
Dosage of medication
Description
Usage of medications last three months. Measured in dosage.
Time Frame
Baseline
Title
Dosage of medication
Description
Usage of medications last three months. Measured in dosage
Time Frame
3 months post baseline
Title
Frequency of medication
Description
Usage of medications last three months. Measured in frequency
Time Frame
3 months post baseline
Title
Dosage of medication
Description
Usage of medications last three months. Measured in dosage.
Time Frame
6 months post baseline
Title
Frequency of medication
Description
Usage of medications last three months. Measured in frequency.
Time Frame
6 months post baseline
Title
Self-reported fatigue
Description
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Time Frame
Baseline
Title
Self-reported fatigue
Description
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Time Frame
3 months post baseline
Title
Self-reported fatigue
Description
Last week's experience of fatigue is measured on a Numeric rating scale from 0 (No fatigue) to 10 (Worst imaginable fatigue).
Time Frame
6 months post baseline
Title
Self-reported pain
Description
Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Time Frame
Baseline
Title
Self-reported pain
Description
Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Time Frame
3 months post baseline
Title
Self-reported pain
Description
Last week's experience of pain measured by numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Time Frame
6 months post baseline
Title
Self-reported physical activity (HUNT)
Description
Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
Time Frame
Baseline
Title
Self-reported physical activity (HUNT)
Description
Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
Time Frame
3 months post baseline
Title
Self-reported physical activity (HUNT)
Description
Measured by questions from the Nord-Trøndelag Health study (HUNT): average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
Time Frame
6 months post baseline
Title
SCORE2
Description
Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.
Time Frame
Baseline
Title
SCORE2
Description
Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.
Time Frame
3 months post baseline
Title
SCORE2
Description
Systemic Coronary Risk Estimation 2 Evaluation: Age, sex, smoking status, non-HDL blood cholesterol and systolic blood pressure is used to estimate 10-year risk of fatal and non-fatal cardiovascular disease.
Time Frame
6 months post baseline
Title
Forced vital capacity
Description
Volume of air that can be forcefully exhaled after a full inspiration, measured in liters. Obtained from spirometry
Time Frame
Baseline
Title
Forced vital capacity
Description
Volume of air that can be forcefully exhaled after a full inspiration, measured in liters- obtained from spirometry
Time Frame
3 months post baseline
Title
Forced vital capacity
Description
Volume of air that can be forcefully exhaled after a full inspiration, measured in liters- obtained from spirometry
Time Frame
6 months post baseline
Title
Forced expiratory volume in 1 second (FEV1)
Description
Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry
Time Frame
Baseline
Title
Forced expiratory volume in 1 second (FEV1)
Description
Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry
Time Frame
3 months post baseline
Title
Forced expiratory volume in 1 second (FEV1)
Description
Volume of air that can be forcefully exhaled in the first second after a full inspiration, measured in liters- obtained by spirometry
Time Frame
6 months post baseline
Title
FEV1/FVC ratio
Description
Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)
Time Frame
Baseline
Title
FEV1/FVC ratio
Description
Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)
Time Frame
3 months post baseline
Title
FEV1/FVC ratio
Description
Ratio (%) of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC)
Time Frame
6 months post baseline
Title
Forced expiratory flow
Description
Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry
Time Frame
Baseline
Title
Forced expiratory flow
Description
Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry
Time Frame
3 months post baseline
Title
Forced expiratory flow
Description
Speed of air during the middle part of a forced expiration, intervals at 25%, 50% and 75% of exhaled FVC, measured in liter per second (L/s) - obtained by spirometry
Time Frame
6 months post baseline
Title
Peak expiratory flow (PEF)
Description
Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry
Time Frame
Baseline
Title
Peak expiratory flow (PEF)
Description
Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry
Time Frame
3 months post baseline
Title
Peak expiratory flow (PEF)
Description
Maximum speed of expiration, expressed in liters per minute (L/min)- obtained from spirometry
Time Frame
6 months post baseline
Title
Maximum voluntary ventilation (MVV)
Description
Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry
Time Frame
Baseline
Title
Maximum voluntary ventilation (MVV)
Description
Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry
Time Frame
3 months post baseline
Title
Maximum voluntary ventilation (MVV)
Description
Measure of the maximum amount of air that can be inhaled and exhaled in one minute. Measured over a 6- or 12-second time period, extrapolated to a value for one minute, expressed in liters/minute (L/min)- obtained from spirometry
Time Frame
6 months post baseline
Title
Psoriatic Arthritis Impact of Disease (PsAID)
Description
Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with psoriatic arthritis.
Time Frame
Baseline
Title
Psoriatic Arthritis Impact of Disease (PsAID)
Description
Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants psoriatic arthritis.
Time Frame
3 months post baseline
Title
Psoriatic Arthritis Impact of Disease (PsAID)
Description
Patient-reported outcome measure for assessing psoriatic arthritis. Calculated based on 9 Numerical rating scales (NRS) questions regarding pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping and anxiety. Each NRS is assessed as a number between 0 and 10. Range of final PsAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with psoriatic arthritis.
Time Frame
6 months post baseline
Title
Rheumatoid arthritis impact of disease (RAID)
Description
Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.
Time Frame
Baseline
Title
Rheumatoid arthritis impact of disease (RAID)
Description
Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.
Time Frame
3 months post baseline
Title
Rheumatoid arthritis impact of disease (RAID)
Description
Patient-reported outcome measure for assessing rheumatoid arthritis. Calculated based on 7 Numerical rating scales (NRS) questions regarding pain, functional capacity, fatigue, physical wellbeing, emotional wellbeing, quality of sleep and coping. Each NRS is assessed as a number between 0 and 10. Range of final RAID value is 0-10 where higher figures indicate worse status. Relevant for study participants with rheumatoid arthritis.
Time Frame
6 months post baseline
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Time Frame
Baseline
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Time Frame
3 months post baseline
Title
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 6 Numerical rating scales (NRS) questions regarding fatigue, pain, spinal pain, joint pain, pain on palpation of areas with localized tenderness, morning stiffness severity and morning stiffness duration. Each NRS is assessed as a number between 0 and 10. Range of final BASDAI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Time Frame
6 months post baseline
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Time Frame
Baseline
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Time Frame
3 months post baseline
Title
Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
Patient-reported outcome measure for assessing functional limitation in patients with ankylosing spondylitis. Calculated based on 10 Numerical rating scales (NRS) questions, 8 questions regarding functional limitations and 2 questions regarding the ability to cope with everyday life. Each NRS is assessed as a number between 0 and 10. Range of final BASFI value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Time Frame
6 months post baseline
Title
Bath Ankylosing Spondylitis Global Score (BAS-G)
Description
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Time Frame
Baseline
Title
Bath Ankylosing Spondylitis Global Score (BAS-G)
Description
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Time Frame
3 months post baseline
Title
Bath Ankylosing Spondylitis Global Score (BAS-G)
Description
Patient-reported outcome measure for assessing ankylosing spondylitis. Calculated based on 2 Numerical rating scales (NRS) questions regarding patients's well-being the previous week and previous six months. Range of final BAS-G value is 0-10 where higher figures indicate worse status. Relevant for study participants with spondyloarthritis.
Time Frame
6 months post baseline
Title
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.
Time Frame
3 months post baseline
Title
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.
Time Frame
6 months post baseline
Title
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
Composite score to assess disease activity in ankylosing spondylitis. Calculated based on three questions from BASDAI, patient global assessment on 0-10 scale and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with spondyloarthritis.
Time Frame
Baseline
Title
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)
Description
Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.
Time Frame
Baseline
Title
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)
Description
Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.
Time Frame
3 months post baseline
Title
Disease Activity Score Calculator for Rheumatoid Arthritis (DAS28)
Description
Composite score to assess disease activity in rheumatoid arthritis. Calculated based on number of swollen (0-28) and tender joints (0-28), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with rheumatoid arthritis.
Time Frame
6 months post baseline
Title
Disease Activity in PSoriatic Arthritis (DAPSA)
Description
Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis
Time Frame
Baseline
Title
Disease Activity in PSoriatic Arthritis (DAPSA)
Description
Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis
Time Frame
3 months post baseline
Title
Disease Activity in PSoriatic Arthritis (DAPSA)
Description
Composite score to assess disease activity in psoriatic arthritis. Calculated based on number of swollen (0-66) and tender joints (0-68), patient global assessment of health and C-Reactive Protein or Erythrocyte Sedimentation Rate from blood samples. Relevant for study participants with psoriatic arthritis
Time Frame
6 months post baseline
Title
Post-exercise questionnaire
Description
Electronic questionnaire distributed to patients in the experimental group upon completion of HIT intervention. 14 statements related to participation in the HIT exercise intervention and perceived intensity, duration and frequency of the exercise intervention. Scored on a 5 point Likert scale ranging from strongly disagree to strongly agree.
Time Frame
3 months post baseline
Title
Use of healthcare services
Description
Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.
Time Frame
Baseline
Title
Use of healthcare services
Description
Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.
Time Frame
3 months post baseline
Title
Use of healthcare services
Description
Use of health care services is measured by number of consultations to general practitioner, medical specialist, physiotherapist, occupational therapist, Healthy Life Centres, psychologist in the last three months.
Time Frame
6 months post baseline
Title
Smoking status
Description
Registered by self-report; I smoke daily, I am a former smoker , I have never smoked
Time Frame
Baseline
Title
Smoking status
Description
Registered by self-report; I smoke daily, I am a former smoker , I have never smoked
Time Frame
3 months post baseline
Title
Smoking status
Description
Registered by self-report; I smoke daily, I am a former smoker , I have never smoked
Time Frame
6 months post baseline
Title
Snuff status
Description
Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff
Time Frame
Baseline
Title
Snuff status
Description
Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff
Time Frame
3 months post baseline
Title
Snuff status
Description
Registered by self-report; I use snuff daily, I have previously used snuff, I have never used snuff
Time Frame
6 months post baseline
Title
Peak heart rate
Description
Peak heart rate observed during CPET
Time Frame
Baseline
Title
Peak heart rate
Description
Peak heart rate observed during CPET
Time Frame
3 months post baseline
Title
Peak heart rate
Description
Peak heart rate observed during CPET
Time Frame
6 months post baseline
Title
Augmentation index
Description
Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure
Time Frame
Baseline
Title
Augmentation index
Description
Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure
Time Frame
3 months post baseline
Title
Augmentation index
Description
Indicator of arterial stiffness, measured by mobil-o-graph at the same time as measure of blood pressure
Time Frame
6 months post baseline
Title
Pulse Wave Velocity
Description
Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure
Time Frame
Baseline
Title
Pulse Wave Velocity
Description
Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure
Time Frame
3 months post baseline
Title
Pulse Wave Velocity
Description
Measure of arterial stiffness- rate at which blood propagates through the vessels. Measured by moil-o-graph at the same time as measure of blood pressure
Time Frame
6 months post baseline
Title
Exercise self-efficacy
Description
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Time Frame
Baseline
Title
Exercise self-efficacy
Description
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Time Frame
3 months post baseline
Title
Exercise self-efficacy
Description
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Time Frame
6 months post baseline
Title
Exercise frequency
Description
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise frequency is recorded.
Time Frame
3 months post baseline
Title
Exercise intensity
Description
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise intensity is recorded by use of a herat rate monitor.
Time Frame
3 months post baseline
Title
Exercise duration
Description
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise duration is recorded.
Time Frame
3 months post baseline
Title
Early session termination
Description
Participants in the experimental group are asked to record individual exercise session in a training diary. Early session termination is recorded.
Time Frame
3 months post baseline
Title
Exercise-related adverse events
Description
Participants in the experimental group are asked to record individual exercise session in a training diary. Exercise-related adverse events are recorded.
Time Frame
3 months post baseline
Title
Self-reported cardiovascular health and symptoms
Description
13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided
Time Frame
Baseline
Title
Self-reported cardiovascular health and symptoms
Description
13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided
Time Frame
3 months post baseline
Title
Self-reported cardiovascular health and symptoms
Description
13 yes/no questions regarding self-report of cardiovascular disease, symptoms and cardiac surgery. If the participant answers yes to preliminary question regarding angina, 5 ancillary questions pertaining to angina symptomatology are provided
Time Frame
6 months post baseline
Title
Self-report change in physical fitness
Description
Patient global change in self-perceived physical fitness measured on a 5-point Likert scale ranging from much better to much worse
Time Frame
3 months post baseline
Title
Self-report change in physical fitness
Description
Patient global change in self-perceived physical fitness measured on a 5-point Likert scale ranging from much better to much worse
Time Frame
6 months post baseline
Title
Self-report exercise habits
Description
Questionnaire; self-report of exercise habits from baseline to 3 months post baseline: Participation in regular exercise (yes/no), if yes: frequency (1-2 times/week, 3-4 times/week, 5 times or more/week) and mode of exercise (endurance exercise, strength exercise, mobility exercise and/or other). These questions are only forwarded to participants in the control group at this timepoint. Exercise habits form baseline to 3 months post baseline is recorded via the training diary for participants allocated to HIIT (experimental group): see outcome 153-157.
Time Frame
3 months post baseline
Title
Self-report exercise habits
Description
Questionnaire; self-report of exercise habits from 3 months post baseline to 6 months post-baseline: Participation in regular exercise (yes/no), if yes: frequency (1-2 times/week, 3-4 times/week, 5 times or more/week) and mode of exercise (endurance exercise, strength exercise, mobility exercise and/or other). These questions are forwarded to all study participants at this timepoint.
Time Frame
6 months post baseline
Title
Corona virus 19 infection
Description
Questionnaire; self-report regarding corona virus 19 infection (yes/no, if yes: hospitalization/no hospitalization) from baseline to 3 months post baseline
Time Frame
3 months post baseline
Title
Corona virus 19 infection
Description
Questionnaire; self-report regarding corona virus 19 infection (yes/no, if yes: hospitalization/no hospitalization) from 3 months post baseline to 6 montsh post baseline
Time Frame
6 months post baseline
Title
Corona virus 19 quarantine
Description
Questionnaire; self-report regarding corona virus 19 quarantine (yes/no) from baseline to 3 months post baseline
Time Frame
3 months post baseline
Title
Corona virus 19 quarantine
Description
Questionnaire; self-report regarding corona virus 19 quarantine (yes/no) from 3 months post baseline to 6 months post baseline
Time Frame
6 months post baseline
Title
Maximum minute ventilation at peak exercise (VEmax, L/min)
Description
Maximum ventilation, recorded from CPET at peak exercise
Time Frame
Baseline
Title
Maximum minute ventilation at peak exercise (VEmax, L/min)
Description
Maximum ventilation, recorded from CPET at peak exercise
Time Frame
3 months post baseline
Title
Maximum minute ventilation at peak exercise (VEmax, L/min)
Description
Maximum ventilation, recorded from CPET at peak exercise
Time Frame
6 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-70 BMI: 18.5-40 Inflammatory joint disease verified by physician Able to walk unaided and continuously for ≥ 15 min. Norwegian or English speaking Exclusion Criteria: Sustained lower extremity injury ≤12 months, including surgery Neurological disease Absolute contraindication to maximal exercise test Cognitive impairment Participation in structured high-intensity exercise ≥ 1/week in the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Therese Tveter, PhD
Organizational Affiliation
National Resource Center for Rehabilitation in Rheumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data may be made available upon sound request to the principal investigator
Citations:
PubMed Identifier
35177467
Citation
Norden KR, Dagfinrud H, Semb AG, Hisdal J, Viktil KK, Sexton J, Fongen C, Skandsen J, Blanck T, Metsios GS, Tveter AT. Effect of high-intensity exercise on cardiorespiratory fitness, cardiovascular disease risk and disease activity in patients with inflammatory joint disease: protocol for the ExeHeart randomised controlled trial. BMJ Open. 2022 Feb 17;12(2):e058634. doi: 10.1136/bmjopen-2021-058634.
Results Reference
derived
Links:
URL
https://bmjopen.bmj.com/content/bmjopen/12/2/e058634.full.pdf
Description
Effect of high-intensity exercise on cardiorespiratory fitness, cardiovascular disease risk and disease activity in patients with inflammatory joint disease: protocol for the ExeHeart randomised controlled trial

Learn more about this trial

Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases

We'll reach out to this number within 24 hrs