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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pulmonary Hypertension

Intervention / Treatment
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* Behavioral: Exercise and Respiratory Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise and Respiratory Training<br> | Behavioral: Exercise and Respiratory Training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in WHO functional classification |  | baseline - 15 weeks afterwards | 
| Borg scale assessed immediately after completion of the stress Doppler echocardiography |  | baseline - 15 weeks afterwards | 
| parameters of echocardiography |  | baseline - 15 weeks afterwards | 
| parameters of gas exchange |  | baseline - 15 weeks afterwards |