Phase 3 Study of Physical Exercise and Respiratory Training as Supportive Treatments for Patients With Severe Chronic Pulmonary Hypertension
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Pulmonary Hypertension
- Sponsor
- Heidelberg University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- distance walked in 6 minutes
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Background
-Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. The present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH.
Methods
-Patients with PH on stable disease-targeted medication will be randomly assigned to a control and a primary training group. Medication will remain unchanged during the study period. Primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life questionnaire. Changes in WHO functional class, Borg scale, and parameters of echocardiography and gas exchange also will be assessed.
Prospects
-We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.
Investigators
Prof. Dr. med. Ekkehard Gruenig
Prof. Dr. med. Ekkehard Grünig
Heidelberg University
Eligibility Criteria
Inclusion Criteria
- •Patients with severe chronic PH who were stable and compensated under optimized medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anticoagulants, diuretics, and supplemental oxygen) for at least 3 months before entering the study will be invited to participate.
- •Additional inclusion criteria will be age of between 18 and 75 years and World Health Organization (WHO) functional class II to IV.
Exclusion Criteria
- •Patients with recent syncope or skeletal or muscle abnormalities prohibiting participation in an exercise program won't be included.
Outcomes
Primary Outcomes
distance walked in 6 minutes
Time Frame: baseline - 15 weeks afterwards
change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire
Time Frame: baseline - 15 weeks afterwards
Secondary Outcomes
- parameters of echocardiography(baseline - 15 weeks afterwards)
- changes in WHO functional classification(baseline - 15 weeks afterwards)
- parameters of gas exchange(baseline - 15 weeks afterwards)
- Borg scale assessed immediately after completion of the stress Doppler echocardiography(baseline - 15 weeks afterwards)