Hypertension, Pulmonary
Conditions
Keywords
Pulmonary arterial hypertension, Chronic thromboembolic pulmonary hypertension, Rehabilitation, Oxygen
Brief summary
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.
Interventions
BEHAVIORALrespiratory and exercise therapy
The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
BEHAVIORALrespiratory and exercise therapy with supplemental oxygen
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.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* WHO functional class II-IV * PH diagnosed by right heart catheter showing: * Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg * Baseline pulmonary vascular resistance (PVR) \> 240 dyn x s x cm-5 * Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mm Hg * Patients receiving maximal PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study * PH target therapy should not be expected to change during the entire 15-week study period * Negative pregnancy test (β-HCG) at the start of the trial * Able to understand and willing to sign the Informed Consent Form
Exclusion criteria
* PH due to significant left heart disease (Wedge ≥ 15mmHg) or lung disease (FEV1 ≤ 60% predicted) * Pregnancy at study onset * Walking disability * Any change in disease-targeted therapy within the last 2 months * Any subject who is scheduled to receive another investigational drug during the course of this study * Any other relevant concomitant disease * Systolic blood pressure \< 85 mmHg * History or suspicion of inability to cooperate adequately
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constant cardiopulmonary exercise testing change in endurance time | Change from Baseline to 15 weeks |
| 6 Minute walking test | Change from Baseline to 15 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sit-to-Stand (physiological parameter) | Baseline, 3 weeks, 15 weeks, 6 and 12 months | Number of Sit-to-Stand performed in 1 minute |
| Stair Ascent (physiological parameter) | Baseline, 3 weeks, 15 weeks, 6 and 12 months | Force, Power and Time needed to climb 5 steps |
| Cognitive function (questionnaire) | Baseline, 3 weeks, 15 weeks, 6 and 12 months | Trail Making Test A & B, Stroop 1-3, 5 point test |
| Functional class (scale) | Baseline, 3 weeks, 15 weeks, 6 and 12 months | — |
| Lung function (physiological parameter) | Baseline, 3 weeks, 15 weeks, 6 and 12 months | Forced vital capacity and liters in 1 second, Total lung capacity, diffusion of carbon dioxide |
| Daily activity (energy expenditure, steps per day, sleep time and efficiency, lying down time, physical activity level, metabolic equivalent units) | Baseline, 3 weeks, 15 weeks, 6 and 12 months | Actigraphy |
| Hemodynamic (physiological parameter) | Baseline, 3 weeks, 15 weeks, 6 and 12 months | Pulmonary artery pressure, cardiac output |
| Quality of Life (questionnaire) | Baseline, 3 weeks, 15 weeks, 6 and 12 months | Minnesota living with heart failure questionnaire, Camphor, short form 36 item |
Other
| Measure | Time frame |
|---|---|
| Hospitalisation days | Baseline, 3 weeks, 15 weeks, 6 and 12 months |
Countries
Switzerland
Contacts
Primary ContactSilvia Ulrich Somaini, PD Dr.
Backup ContactStéphanie Saxer, MSc
Outcome results
None listed