Effect of Exercise Training in Patients With Pulmonary Hypertension

Study Purpose

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.#46; 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02558582
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Zurich
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Silvia Ulrich Somaini, PD Dr.
Principal Investigator Affiliation	UniversityHospital Zurich
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Switzerland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hypertension, Pulmonary

Arms & Interventions

Arms

Experimental: Immediate Rehabilitation

The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.

Experimental: Immediate Rehabilitation with 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.

Experimental: Delayed Rehabilitation

Experimental: Delayed Rehabilitation with oxygen

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.

Interventions

Behavioral: - respiratory and exercise therapy

The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.

Behavioral: - respiratory and exercise therapy with supplemental oxygen

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