NCT01398345

Exercise and Respiratory Training as Supportive Treatments for Patients With Chronic Pulmonary Hypertension

Phase 3 Study of Physical Exercise and Respiratory Training as Supportive Treatments for Patients With Severe Chronic Pulmonary Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pulmonary Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-04-01
• Primary completion: 2006-12-01
• First posted: 2011-07-20
• Last updated: 2014-07-02

Locations

1 site across 1 country: Germany