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

NCT01398345 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-07-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2006-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01398345 on ClinicalTrials.gov