Exercise and Respiratory Training as Supportive Treatments for Patients With Chronic Pulmonary Hypertension
—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.
—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.
—We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.
|Chronic Pulmonary Hypertension||Behavioral: Exercise and Respiratory Training||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 3 Study of Physical Exercise and Respiratory Training as Supportive Treatments for Patients With Severe Chronic Pulmonary Hypertension|
- 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 ]
- changes in WHO functional classification [ Time Frame: baseline - 15 weeks afterwards ]
- Borg scale assessed immediately after completion of the stress Doppler echocardiography [ Time Frame: baseline - 15 weeks afterwards ]
- parameters of echocardiography [ Time Frame: baseline - 15 weeks afterwards ]
- parameters of gas exchange [ Time Frame: baseline - 15 weeks afterwards ]
|Study Start Date:||April 2003|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
|Active Comparator: Exercise and Respiratory Training||
Behavioral: Exercise and Respiratory Training
Patients in the interventional group will participate in an exercise program 7 days a week at low workloads (10 to 60 W) that will be supervised by physical therapists and physicians.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398345
|Heidelberg, Germany, 69126|