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High-intensity Interval Exercise in Rheumatoid Arthritis (RA-HIIT)

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
High intensity exercise
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Rheumatoid arthritis disease according to the American College of Rheumatology (ACR)/ The European Alliance of Associations for Rheumatology (EULAR) 1987/2010 criteria Disease duration >1 year Age (range 20-60 years) Stable medication on anti- rheumatic drugs for >3 months Low-to-moderate disease activity (<5.1) according to the Disease activity score 28 (DAS28) Exclusion Criteria: Cerebrovascular diseases Diabetes Severe hypertension Chronic obstructive pulmonary disease or other severe pulmonary diseases Other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise Arthroplasty of large joints Inability to manage Cardiopulmonary Exercise Testing (CPET) Pregnancy Already participating in regular aerobic or strength exercise at a high intensity level (>1 hours/ week) during the last 6 months Inability to speak or read Swedish.

Sites / Locations

  • Sahlgrenska university hospitalRecruiting
  • Uddevalla HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Care as usual

Arm Description

Cardiorespiratory and strength exercise training 2-3 sessions per week

Care as usual and information of health enhancing physical activity according to general recommendations

Outcomes

Primary Outcome Measures

Cardiopulmonary function
Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)

Secondary Outcome Measures

Vascular function
Aortic pulse wave velocity (PWV) (m/sec.) (Higher PWV value indicate worse vascular function)
Level of disease activity
Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Level of disease activity
Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Level of disease activity
Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Homeostatic model assessment of insulin resistance (HOMA IR)
Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report HOMA IR
Glycosylation level of hemoglobin (HbA1c)
Glycosylation level of hemoglobin (mmol/mol)
Level of blood lipids
Levels of triglycerides (mmol/L), Level of high-density lipoprotein (HDL) (mmol/L), low-density lipoprotein (LDL) ( mmol/L), Total cholesterol (mmol/L )
Erythrocyte Sedimentation Rate (ESR)
Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
Erythrocyte Sedimentation Rate (ESR)
Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
Erythrocyte Sedimentation Rate (ESR)
Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
C-Reactive Protein (CRP)
Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
C-Reactive Protein (CRP)
Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
C-Reactive Protein (CRP)
Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
Cytokine levels
Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL)
Muscle function of lower extremities
The one minute sit-to-stand test (Higher numbers of complete rises indicate better muscle function in lower extremities)
Hand-grip force
Hand-grip force is assessed with a dynamometer ( Higher value indicate better grip strength)
Self-reported physical activity
Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)
Self-reported physical activity
Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)
Self-reported physical activity
Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)
Objective assessment of physical activity
Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)
Objective assessment of physical activity
Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)
Objective assessment of physical activity
Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)
Pain intensity
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Pain intensity
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Pain intensity
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Global health
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Global health
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Global health
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Fatigue
The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Fatigue
The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Fatigue
The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Sleep
Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Sleep
Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Sleep
Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Activity limitations
Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)
Activity limitations
Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)
Activity limitations
Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)
Attitude to exercise
Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Attitude to exercise
Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Attitude to exercise
Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Body compositions
Weight and height will be combined to report Body mass index BMI kg/m2 (A higher score indicate higher relative weight)
Waist circumference
Measured with a tape measure midway between the lower rib and iliac crest. (A waist measurement of 80 centimeters or more for women and 94 centimeters or more for men indicate increased risk for diseases related to overweight)

Full Information

First Posted
September 6, 2021
Last Updated
March 15, 2023
Sponsor
Vastra Gotaland Region
Collaborators
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT05768165
Brief Title
High-intensity Interval Exercise in Rheumatoid Arthritis
Acronym
RA-HIIT
Official Title
Expected Health Benefits on Cardiovascular Function, Inflammation and Quality of Life With High-intensity Interval Exercise for Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
Collaborators
Göteborg University

4. Oversight

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

5. Study Description

Brief Summary
Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention versus care as usual
Masking
InvestigatorOutcomes Assessor
Masking Description
Single blinded
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Cardiorespiratory and strength exercise training 2-3 sessions per week
Arm Title
Care as usual
Arm Type
No Intervention
Arm Description
Care as usual and information of health enhancing physical activity according to general recommendations
Intervention Type
Behavioral
Intervention Name(s)
High intensity exercise
Other Intervention Name(s)
Person- centeredness
Intervention Description
Twelve weeks of supervised high intensity aerobic and resistance exercise including two sessions/week, one additional session of the patient´s own choice, non-supervised. The target of the high intensity intervals (HIIT) is 90%-95% of maximum heart rate alternated with recovery phases at 70% of maximal heart rate. The resistance exercise session of large muscle groups: 8-10 repetitions, 2-3 sets. Exercise guidance follows principles of self-efficacy and person-centeredness.
Primary Outcome Measure Information:
Title
Cardiopulmonary function
Description
Maximum oxygen uptake (VO2ml/min/kg) (Higher value indicate better cardiorespiratory capacity)
Time Frame
0 -12 weeks
Secondary Outcome Measure Information:
Title
Vascular function
Description
Aortic pulse wave velocity (PWV) (m/sec.) (Higher PWV value indicate worse vascular function)
Time Frame
0-12 weeks
Title
Level of disease activity
Description
Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Time Frame
0-12 weeks
Title
Level of disease activity
Description
Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Time Frame
0-6 months
Title
Level of disease activity
Description
Disease activity score 28 (DAS28) (Range 0-10 where a higher score indicate worse disease activity)
Time Frame
0-12 months
Title
Homeostatic model assessment of insulin resistance (HOMA IR)
Description
Measure of insulin resistance (fasting glucose (mmol/L) and fasting insulin (mIU/ L) will be combined to report HOMA IR
Time Frame
0-12 weeks
Title
Glycosylation level of hemoglobin (HbA1c)
Description
Glycosylation level of hemoglobin (mmol/mol)
Time Frame
0-12 weeks
Title
Level of blood lipids
Description
Levels of triglycerides (mmol/L), Level of high-density lipoprotein (HDL) (mmol/L), low-density lipoprotein (LDL) ( mmol/L), Total cholesterol (mmol/L )
Time Frame
0-12 weeks
Title
Erythrocyte Sedimentation Rate (ESR)
Description
Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
Time Frame
0-12 weeks
Title
Erythrocyte Sedimentation Rate (ESR)
Description
Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
Time Frame
0-6 months
Title
Erythrocyte Sedimentation Rate (ESR)
Description
Level of high sensitivity ESR (mm/h) (Higher score indicate higher inflammation)
Time Frame
0-12 months
Title
C-Reactive Protein (CRP)
Description
Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
Time Frame
0-12 weeks
Title
C-Reactive Protein (CRP)
Description
Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
Time Frame
0-6 months
Title
C-Reactive Protein (CRP)
Description
Level of high sensitivity CRP (mg/L) (Higher score indicate higher inflammation)
Time Frame
0-12 months
Title
Cytokine levels
Description
Interleukin-6 (pg/mL), interleukin-10 (pg/mL), tumour necrosis factor-alpha (pg/mL)
Time Frame
0-12 weeks
Title
Muscle function of lower extremities
Description
The one minute sit-to-stand test (Higher numbers of complete rises indicate better muscle function in lower extremities)
Time Frame
0-12 weeks
Title
Hand-grip force
Description
Hand-grip force is assessed with a dynamometer ( Higher value indicate better grip strength)
Time Frame
0-12 weeks
Title
Self-reported physical activity
Description
Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)
Time Frame
0-12 weeks
Title
Self-reported physical activity
Description
Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)
Time Frame
0-6 months
Title
Self-reported physical activity
Description
Self-reported questionnaire of habitual physical activity during a typical week. Numbers of hours on low, moderate and high intensity is summed for each category (A minimum of 150 minutes on moderate intensity or 75 minutes on high intensity are equal to health enhancing physical activity according to World Health Organization guidelines)
Time Frame
0-12 months
Title
Objective assessment of physical activity
Description
Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)
Time Frame
0-12 weeks
Title
Objective assessment of physical activity
Description
Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)
Time Frame
0-6 months
Title
Objective assessment of physical activity
Description
Accelerometer to assess habitual physical activity during a typical week. Total time of physical activity and physical activity pattern assessed as time spent at different physical activity intensity levels are obtained using the metabolic equivalent of task values (METS). (Higher METs value indicate higher physical activity level.)
Time Frame
0-12 months
Title
Pain intensity
Description
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Time Frame
0-12 weeks
Title
Pain intensity
Description
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Time Frame
0-6 months
Title
Pain intensity
Description
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse pain)
Time Frame
0-12 months
Title
Global health
Description
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Time Frame
0-12 weeks
Title
Global health
Description
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Time Frame
0-6 months
Title
Global health
Description
Visual Analogue Scale (VAS) (0-100, Higher score indicate worse health)
Time Frame
0-12 months
Title
Fatigue
Description
The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Time Frame
0-12 weeks
Title
Fatigue
Description
The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Time Frame
0-6 months
Title
Fatigue
Description
The Multiple Fatigue Inventory (MFI-20) (4-20 for each subscale, Higher score indicates a higher degree of fatigue
Time Frame
0-12 months
Title
Sleep
Description
Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Time Frame
0-12 weeks
Title
Sleep
Description
Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Time Frame
0-6 months
Title
Sleep
Description
Pittsburgh Sleep Quality Index (0-21, Higher score indicate worse sleep quality).
Time Frame
0-12 months
Title
Activity limitations
Description
Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)
Time Frame
0-12 weeks
Title
Activity limitations
Description
Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)
Time Frame
0-6 months
Title
Activity limitations
Description
Health Assessment Questionnaire (HAQ) (0-3, Higher score indicate worse activity limitations)
Time Frame
0-12 months
Title
Attitude to exercise
Description
Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Time Frame
0-12 weeks
Title
Attitude to exercise
Description
Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Time Frame
0-6 moths
Title
Attitude to exercise
Description
Exercise Health Beliefs questionnaire (20-100, Higher score represents stronger exercise health beliefs.
Time Frame
0-12 months
Title
Body compositions
Description
Weight and height will be combined to report Body mass index BMI kg/m2 (A higher score indicate higher relative weight)
Time Frame
0-12 weeks
Title
Waist circumference
Description
Measured with a tape measure midway between the lower rib and iliac crest. (A waist measurement of 80 centimeters or more for women and 94 centimeters or more for men indicate increased risk for diseases related to overweight)
Time Frame
0-12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rheumatoid arthritis disease according to the American College of Rheumatology (ACR)/ The European Alliance of Associations for Rheumatology (EULAR) 1987/2010 criteria Disease duration >1 year Age (range 20-60 years) Stable medication on anti- rheumatic drugs for >3 months Low-to-moderate disease activity (<5.1) according to the Disease activity score 28 (DAS28) Exclusion Criteria: Cerebrovascular diseases Diabetes Severe hypertension Chronic obstructive pulmonary disease or other severe pulmonary diseases Other severe diseases that may be associated with adverse events or restrict participation in high-intensity exercise Arthroplasty of large joints Inability to manage Cardiopulmonary Exercise Testing (CPET) Pregnancy Already participating in regular aerobic or strength exercise at a high intensity level (>1 hours/ week) during the last 6 months Inability to speak or read Swedish.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annelie Bilberg, PhD
Phone
+46313421195
Email
annelie.bilberg@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Bjersing, Assoc Prof
Email
jan.bjersing@rheuma.gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annelie Bilberg, PhD
Organizational Affiliation
Vastra Gotaland Region
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgrenska university hospital
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelie Bilberg, PhD
Phone
+46313421195
Email
annelie.bilberg@vgregion.se
Facility Name
Uddevalla Hospital
City
Uddevalla
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelie Bilberg, PhD
Phone
+46313421195
Email
annelie.bilberg@vgregion.se
First Name & Middle Initial & Last Name & Degree
Jenny Sivertsson, MSc
Email
jenny.sivertsson@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD
No

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High-intensity Interval Exercise in Rheumatoid Arthritis

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