Pulmonary Hypertension (PH) is a serious disease with a dismal prognosis when left untreated. Advances in medical therapy have improved survival according to recent registries and systematic reviews, but are associated with high healthcare costs. Earlier studies in Heidelberg, Germany showed good evidence for the effect of exercise training on improving exercise performance, quality of life and pulmonary hemodynamics in patients with pulmonary hypertension. The main objectives of the present project are: 1. to investigate the quality of the implementation of a standardized 3 week in-hospital exercise training program on markers of outcome and disease severity in PH-patients in Switzerland immediately after training and after 3 and 12 month. 2. to look whether training with hyperoxia vs. standard care might be more effective. This is a multicentre, randomized parallel-group trial where the intervention rehabilitation is delayed in one group so that they can serve as standard care controls for the others. In a nested single-centre randomized-controlled trial patent will additionally be randomized to receive either usual rehabilitation (UR) or rehabilitation with standardized supplemental oxygen therapy (SSOT) during nights and ergometer training. Patients will receive a PH specific rehabilitation program during 3 weeks followed by an instructed home-based training program for 12 weeks. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights upon written informed consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights.
UniversityHospital Zurich, Department of Pulmonology
Zurich, Switzerland
RECRUITING6 Minute walking test
Time frame: Change from Baseline to 15 weeks
Constant cardiopulmonary exercise testing change in endurance time
Time frame: Change from Baseline to 15 weeks
Quality of Life (questionnaire)
Minnesota living with heart failure questionnaire, Camphor, short form 36 item
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Sit-to-Stand (physiological parameter)
Number of Sit-to-Stand performed in 1 minute
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Stair Ascent (physiological parameter)
Force, Power and Time needed to climb 5 steps
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Cognitive function (questionnaire)
Trail Making Test A \& B, Stroop 1-3, 5 point test
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Hemodynamic (physiological parameter)
Pulmonary artery pressure, cardiac output
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Functional class (scale)
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Lung function (physiological parameter)
Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
Daily activity (energy expenditure, steps per day, sleep time and efficiency, lying down time, physical activity level, metabolic equivalent units)
Actigraphy
Time frame: Baseline, 3 weeks, 15 weeks, 6 and 12 months
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