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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and Respiratory Training | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 | |
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Inclusion Criteria:
Additional inclusion criteria will be age of between 18 and 75 years and World Health Organization (WHO) functional class II to IV.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxklinik Heidelberg | Heidelberg | 69126 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22848542 | Derived | Nagel C, Prange F, Guth S, Herb J, Ehlken N, Fischer C, Reichenberger F, Rosenkranz S, Seyfarth HJ, Mayer E, Halank M, Grunig E. Exercise training improves exercise capacity and quality of life in patients with inoperable or residual chronic thromboembolic pulmonary hypertension. PLoS One. 2012;7(7):e41603. doi: 10.1371/journal.pone.0041603. Epub 2012 Jul 25. |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| parameters of echocardiography |
| baseline - 15 weeks afterwards |
| parameters of gas exchange | baseline - 15 weeks afterwards |