Completed

NCT Number: NCT01398345

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

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.

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Key information

Conditions

Chronic Pulmonary Hypertension

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thoraxklinik Heidelberg

Heidelberg, 69126, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise and Respiratory Training

Behavioral

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.

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

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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2006
First posted: Jul 20, 2011
Registry last updated: Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.