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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
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: 1. Interval training on a cyclo-ergometer 2. Strength training of the upper and lower extremities 3. Guided walks
University Hospitals Leuven
Leuven, Belgium
RECRUITINGChange 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).
Time frame: Baseline, 4 weeks, 15 weeks
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
Time frame: Baseline, 4 weeks, 15 weeks
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.
Time frame: Baseline, 4 weeks, 15 weeks
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.
Time frame: Baseline, 15 weeks
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.
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Time frame: Baseline, 4 weeks, 15 weeks
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.
Time frame: Baseline, 15 weeks
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.
Time frame: Baseline, 4 weeks, 15 weeks
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.
Time frame: Baseline, 4 weeks, 15 weeks
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.
Time frame: Baseline, 4 wekes, 15 weeks
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
Time frame: Baseline, 15 weeks
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
Time frame: Baseline, 15 weeks
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.
Time frame: Baseline, 15 weeks
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.
Time frame: 15 weeks