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

Phase 3

Completed

• Conditions: Chronic Pulmonary Hypertension
• Interventions: Behavioral: Exercise and Respiratory Training

• Registration Number: NCT01398345
• Lead Sponsor: Heidelberg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2006-12
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise and Respiratory Training	Exercise and Respiratory Training	-

Primary Outcome Measures

Name	Time	Method
distance walked in 6 minutes	baseline - 15 weeks afterwards
change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire	baseline - 15 weeks afterwards

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Germany