Back to resultsRehabilitation for Patients With Pulmonary Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary rehabilitation, physical activity
Eligibility Criteria
Inclusion Criteria:
- Female and male patients ≥ 18 years
- Pulmonary arterial hypertension (PAH, Group 1 of Nice classification) and chronic thromboembolic pulmonary hypertension (CTEPH, group 4)
- WHO functional class II-III
PH diagnosed by right heart catheter showing:
- Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
- Baseline pulmonary vascular resistance (PVR) ≥ 240dyn x s x cm-5
- Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHgg
- Patients receiving optimized conventional PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study.
- Except for diuretics, medical treatment should not be expected to change during the entire 15-week study period.
- Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the study for women with child- bearing potential
- Able to understand and willing to sign the Informed Consent Form
Exclusion Criteria:
- PH of any cause other than permitted in the entry criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease based on pulmonary edema during a previous vasoreactivity test or on abnormal findings compatible with this diagnosis (septal lines or pulmonary edema at high resolution computer tomography), congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension or unclear diagnosis
- Patients with signs of right heart decompensation
- Walking disability
- Acute infection, pyrexia
- Any change in disease-targeted therapy within the last 2 months
- Any subject who is scheduled to receive an investigational drug during the course of this study
- Severe lung disease: FEV1/FVC <0.5 and total lung capacity <70% of the normal value
- Active myocarditis, instable angina pectoris, exercise induced ventricular arrhythmias, decompensated heart failure, active liver disease, porphyria or elevations of serum transaminases >3 x ULN (upper limit of normal) or bilirubin >1.5 x ULN
- Hemoglobin concentration of less than 75% of the lower limit of normal
- Systolic blood pressure <85 mmHg
- History or suspicion of inability to cooperate adequately
Sites / Locations
- University Hospitals LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rehabilitation group
Control group
Arm Description
15 weeks pulmonary rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home-based rehabilitation.
Usual care
Outcomes
Primary Outcome Measures
Change in functional exercise capacity
Change in six minutes-walk distance measured at baseline, after 4 weeks and at the end of the study (15 weeks after randomization).
Secondary Outcome Measures
Difference in change over time between the rehabilitation and the control group in SF-36
Health related quality of life (HRQoL) will be measured by the extensively validated generic HRQoL questionnaire, the 36-Item Short Form Survey Instrument (SF-36). This questionnaire includes two main scores with a physical component and an emotional component scale and eight subscales. The score ranges between 0 and 100, higher scores indicate a better quality of life. The questionnaire is self-administered and will be completed on paper
Difference in change over time between the rehabilitation and the control group in EmPHasis-10.
Health related quality of life (HRQoL) will be measured the EmPHasis-10 questionnaire, measuring the impact of PH on health related quality of life. The score ranges between 0 and 50, higher scores indicate worse quality of life.
Change from baseline to 15 weeks between the rehabilitation and the control group in WHO functional class
The WHO functional classification ranges from class I (patients with PH but without resting limitation of physical activity) to class IV (patients with PH with inability to carry out any physical activity without symptoms). The WHO functional class is a powerful predictor of survival in patients with PH.
Difference in change over time between the rehabilitation and the control group in Borgscale at the end of the 6MWD test
Borg (0-10) scale reporting on dyspnea and fatigue will be administered at the end of the six-minutes walk test. The score ranges between 0 and 10, a higher score means more symptoms of dyspnea / fatigue.
Change from baseline to 15 weeks between the rehabilitation and the control group in maximal exercise capacity
Maximal exercise capacity will be assessed by a maximal incremental cycling test. After a 2-min resting period and 3 minutes of unloaded cycling, the patients will start at 20 W and cycle until symptom limitation at an incremental workload of 10 W/min. Oxygen consumption, carbon dioxide output and ventilation will be measured breath by breath (Vmax series, SensorMedics, Anaheim, CA). Heart rate and oxygen saturation will be registered continuously. Peak workload, oxygen consumption (VO2 max), heart rate, blood pressure, oxygen saturation, ventilation and VE/VCO2 slope will be retrieved.
Difference in change over time between the rehabilitation and the control group in Objectively measured physical activity
At every time point, physical activity will be measured for 1 week, using a physical activity monitor validated to be used in patients with respiratory disease. Patients will be asked to wear the monitor during waking hours. The mean number of steps per day and time spent in activities of at least moderate intensity will be retrieved as outcomes.
Difference in change over time between the rehabilitation and the control group in symptoms of anxiety and depression (HADs questionnaire)
Symptoms of anxiety and depression will be assessed by the Depression, Anxiety, and Stress Scale. This questionnaires is self-administered and will be completed on paper. Higher scores indicate more symptoms of anxiety / depression.
Difference in change over time between the rehabilitation and the control group in Isometric quadriceps force
An isometric maximal volitional contraction of the right quadriceps muscle be performed using the Biodex dynamometer with the patient seated with a 90° hip and 60° knee flexion. The best of 3 reproducible measurements will be retrieved as a measure of quadriceps force.
Change from baseline to 15 weeks between the rehabilitation and the control group in hemodynamics measured by echocardiography
Hemodynamics measured by echocardiography at rest and during a symptom limiting exercise test. The following outcomes will be investigated: Change in tricuspid annular plane systolic excursion, Change in tissue Doppler imaging, Change in left ventricular pump function, Change in right ventricular pump function , Change in thickness of interventricular septum, Change insize of inferior vena cava, Change in systolic pulmonary arterial pressure, Change in left ventricular eccentricity index, Change in Tei index , Change in right ventricular area, Change in right atrial area
Change from baseline to 15 weeks between the rehabilitation and the control group in proportion of patients who exceeded the MID in 6MWD
MID will be defined as an increase of at least 30m
Change from baseline to 15 weeks between the rehabilitation and the control group in heart function as measured by MRI (optional)
MRI scan at rest and during exercise combined with right heart catherization and blood sampling before and after the exercise protocol.
adverse events
Patients will be asked about visits to general practitioner and hospitalizations due to any medical reasons in order to control the occurrence of adverse events. In a semi-structured way,, occurrence of exercise related and non-exercise related adverse events will be collected.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03955016
Brief Title
Rehabilitation for Patients With Pulmonary Hypertension
Official Title
A Randomized Controlled Trial to Evaluate the Effect of a Rehabilitation Program on the Exercise Capacity of Patients With Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
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
The purpose of this study is to test the impact of a personalized, partly supervised rehabilitation program on the exercise capacity in patients with pulmonary hypertension. The rehabilitation program consists of 2 weeks inpatient, 2 weeks ambulatory and 11 weeks home based rehabilitation.
Detailed Description
The present study is a 15 weeks, randomized (1:1) controlled trial. Patients in both groups will not change their usual medical treatment. After 2 clinical visits (screening and randomization visit), patients in the intervention group will follow a 15 week rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home based rehabilitation. At the end of the outpatient rehabilitation phase (week 4) and the home-based program (week 15), clinical outcomes will be reassessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary rehabilitation, physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Outcome assessor will be blinded for the outcome
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation group
Arm Type
Experimental
Arm Description
15 weeks pulmonary rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home-based rehabilitation.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
Rehabilitation program consisting of 2 weeks inpatient (supervised training 5 times per week), 2 weeks outpatient (supervised sessions 3 times per week) and 11 weeks home-based exercise training (weekly phone call).
During the inpatient phase, patients will receive on top of the supervised training sessions a consultation of the dietitian, PH psychologist, social worker and specialized nurse. During the ambulatory rehabilitation phase patients will have 2 session with the occupational therapist.
Every supervised training session contains:
Interval training on a cyclo-ergometer
Strength training of the upper and lower extremities
Guided walks
Primary Outcome Measure Information:
Title
Change in functional exercise capacity
Description
Change in six minutes-walk distance measured at baseline, after 4 weeks and at the end of the study (15 weeks after randomization).
Time Frame
Baseline, 4 weeks, 15 weeks
Secondary Outcome Measure Information:
Title
Difference in change over time between the rehabilitation and the control group in SF-36
Description
Health related quality of life (HRQoL) will be measured by the extensively validated generic HRQoL questionnaire, the 36-Item Short Form Survey Instrument (SF-36). This questionnaire includes two main scores with a physical component and an emotional component scale and eight subscales. The score ranges between 0 and 100, higher scores indicate a better quality of life. The questionnaire is self-administered and will be completed on paper
Time Frame
Baseline, 4 weeks, 15 weeks
Title
Difference in change over time between the rehabilitation and the control group in EmPHasis-10.
Description
Health related quality of life (HRQoL) will be measured the EmPHasis-10 questionnaire, measuring the impact of PH on health related quality of life. The score ranges between 0 and 50, higher scores indicate worse quality of life.
Time Frame
Baseline, 4 weeks, 15 weeks
Title
Change from baseline to 15 weeks between the rehabilitation and the control group in WHO functional class
Description
The WHO functional classification ranges from class I (patients with PH but without resting limitation of physical activity) to class IV (patients with PH with inability to carry out any physical activity without symptoms). The WHO functional class is a powerful predictor of survival in patients with PH.
Time Frame
Baseline, 15 weeks
Title
Difference in change over time between the rehabilitation and the control group in Borgscale at the end of the 6MWD test
Description
Borg (0-10) scale reporting on dyspnea and fatigue will be administered at the end of the six-minutes walk test. The score ranges between 0 and 10, a higher score means more symptoms of dyspnea / fatigue.
Time Frame
Baseline, 4 weeks, 15 weeks
Title
Change from baseline to 15 weeks between the rehabilitation and the control group in maximal exercise capacity
Description
Maximal exercise capacity will be assessed by a maximal incremental cycling test. After a 2-min resting period and 3 minutes of unloaded cycling, the patients will start at 20 W and cycle until symptom limitation at an incremental workload of 10 W/min. Oxygen consumption, carbon dioxide output and ventilation will be measured breath by breath (Vmax series, SensorMedics, Anaheim, CA). Heart rate and oxygen saturation will be registered continuously. Peak workload, oxygen consumption (VO2 max), heart rate, blood pressure, oxygen saturation, ventilation and VE/VCO2 slope will be retrieved.
Time Frame
Baseline, 15 weeks
Title
Difference in change over time between the rehabilitation and the control group in Objectively measured physical activity
Description
At every time point, physical activity will be measured for 1 week, using a physical activity monitor validated to be used in patients with respiratory disease. Patients will be asked to wear the monitor during waking hours. The mean number of steps per day and time spent in activities of at least moderate intensity will be retrieved as outcomes.
Time Frame
Baseline, 4 weeks, 15 weeks
Title
Difference in change over time between the rehabilitation and the control group in symptoms of anxiety and depression (HADs questionnaire)
Description
Symptoms of anxiety and depression will be assessed by the Depression, Anxiety, and Stress Scale. This questionnaires is self-administered and will be completed on paper. Higher scores indicate more symptoms of anxiety / depression.
Time Frame
Baseline, 4 weeks, 15 weeks
Title
Difference in change over time between the rehabilitation and the control group in Isometric quadriceps force
Description
An isometric maximal volitional contraction of the right quadriceps muscle be performed using the Biodex dynamometer with the patient seated with a 90° hip and 60° knee flexion. The best of 3 reproducible measurements will be retrieved as a measure of quadriceps force.
Time Frame
Baseline, 4 wekes, 15 weeks
Title
Change from baseline to 15 weeks between the rehabilitation and the control group in hemodynamics measured by echocardiography
Description
Hemodynamics measured by echocardiography at rest and during a symptom limiting exercise test. The following outcomes will be investigated: Change in tricuspid annular plane systolic excursion, Change in tissue Doppler imaging, Change in left ventricular pump function, Change in right ventricular pump function , Change in thickness of interventricular septum, Change insize of inferior vena cava, Change in systolic pulmonary arterial pressure, Change in left ventricular eccentricity index, Change in Tei index , Change in right ventricular area, Change in right atrial area
Time Frame
Baseline, 15 weeks
Title
Change from baseline to 15 weeks between the rehabilitation and the control group in proportion of patients who exceeded the MID in 6MWD
Description
MID will be defined as an increase of at least 30m
Time Frame
Baseline, 15 weeks
Title
Change from baseline to 15 weeks between the rehabilitation and the control group in heart function as measured by MRI (optional)
Description
MRI scan at rest and during exercise combined with right heart catherization and blood sampling before and after the exercise protocol.
Time Frame
Baseline, 15 weeks
Title
adverse events
Description
Patients will be asked about visits to general practitioner and hospitalizations due to any medical reasons in order to control the occurrence of adverse events. In a semi-structured way,, occurrence of exercise related and non-exercise related adverse events will be collected.
Time Frame
15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female and male patients ≥ 18 years
Pulmonary arterial hypertension (PAH, Group 1 of Nice classification) and chronic thromboembolic pulmonary hypertension (CTEPH, group 4)
WHO functional class II-III
PH diagnosed by right heart catheter showing:
Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
Baseline pulmonary vascular resistance (PVR) ≥ 240dyn x s x cm-5
Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHgg
Patients receiving optimized conventional PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study.
Except for diuretics, medical treatment should not be expected to change during the entire 15-week study period.
Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the study for women with child- bearing potential
Able to understand and willing to sign the Informed Consent Form
Exclusion Criteria:
PH of any cause other than permitted in the entry criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease based on pulmonary edema during a previous vasoreactivity test or on abnormal findings compatible with this diagnosis (septal lines or pulmonary edema at high resolution computer tomography), congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension or unclear diagnosis
Patients with signs of right heart decompensation
Walking disability
Acute infection, pyrexia
Any change in disease-targeted therapy within the last 2 months
Any subject who is scheduled to receive an investigational drug during the course of this study
Severe lung disease: FEV1/FVC <0.5 and total lung capacity <70% of the normal value
Active myocarditis, instable angina pectoris, exercise induced ventricular arrhythmias, decompensated heart failure, active liver disease, porphyria or elevations of serum transaminases >3 x ULN (upper limit of normal) or bilirubin >1.5 x ULN
Hemoglobin concentration of less than 75% of the lower limit of normal
Systolic blood pressure <85 mmHg
History or suspicion of inability to cooperate adequately
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wim Janssens, Prof
Phone
0032 16 34 68 33
Email
wim.janssens@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Delcroix, Prof
Email
marion.delcroix@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Janssens, Prof
Organizational Affiliation
University hospitals Leuven, KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wim Janssens, Prof
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Rehabilitation for Patients With Pulmonary Hypertension
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