Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Rehabilitation | Experimental | The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. |
|
| Immediate Rehabilitation with oxygen | Experimental | 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. |
|
| Delayed Rehabilitation | Experimental | Waiting group that participates in the rehabilitation program after 3 months. The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. |
|
| Delayed Rehabilitation with oxygen | Experimental | Waiting group that participates in the rehabilitation program after 3 months. 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| respiratory and exercise therapy | Behavioral | The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute walking test | Change from Baseline to 15 weeks | |
| Constant cardiopulmonary exercise testing change in endurance time | Change from Baseline to 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (questionnaire) | Minnesota living with heart failure questionnaire, Camphor, short form 36 item | Baseline, 3 weeks, 15 weeks, 6 and 12 months |
| Sit-to-Stand (physiological parameter) |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalisation days | Baseline, 3 weeks, 15 weeks, 6 and 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Ulrich Somaini, PD Dr. | Contact | 0041442552220 | silvia.ulrich@usz.ch | |
| Stéphanie Saxer, MSc | Contact | 0041442552220 | stephanie.saxer@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Ulrich Somaini, PD Dr. | UniversityHospital Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UniversityHospital Zurich, Department of Pulmonology | Recruiting | Zurich | 8091 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D056152 | Respiratory Rate |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| respiratory and exercise therapy with supplemental oxygen | Behavioral | 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. |
|
Number of Sit-to-Stand performed in 1 minute
| Baseline, 3 weeks, 15 weeks, 6 and 12 months |
| Stair Ascent (physiological parameter) | Force, Power and Time needed to climb 5 steps | Baseline, 3 weeks, 15 weeks, 6 and 12 months |
| Cognitive function (questionnaire) | Trail Making Test A & B, Stroop 1-3, 5 point test | Baseline, 3 weeks, 15 weeks, 6 and 12 months |
| Hemodynamic (physiological parameter) | Pulmonary artery pressure, cardiac output | Baseline, 3 weeks, 15 weeks, 6 and 12 months |
| Functional class (scale) | 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 | 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 | Baseline, 3 weeks, 15 weeks, 6 and 12 months |
| D002318 |
| Cardiovascular Diseases |
| D012119 |
| Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |