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The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated pulmonary arterial hypertension (APAH) as part of a congenital heart defect with / without Eisenmenger's Syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory and exercise therapy | Active Comparator | Randomized, prospective, controlled, blinded study of three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional rehabilitation without a specific training program. After 15 weeks training is also offered to patients in the control group. |
|
| Control group without exercise training | No Intervention | patients of the control group continue their sedentary lifestyle without given advice for exercise training. The time before start of rehabilitation (three months) serves as control group. Afterwards patients take part in the training program as well. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| respiratory and exercise therapy | Other | Conventional therapy with specific respiratory and physical therapy plus mental walking training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the maximum 6-minute walk distance (6MGT) | up to 15 weeks | |
| Changes in quality of life | up to 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hemodynamics |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ekkehard Gruenig, MD | Contact | +49 6221 396 8053 | ekkehard.gruenig@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Ekkehard Gruenig, MD | Center for pulmonary hypertension, Thoraxclinic Heidelberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| : Center for pulmonary Hypertension, Thoraxclinic Heidelberg | Recruiting | Heidelberg | 69126 | Germany |
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| up to 15 weeks |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D004541 | Eisenmenger Complex |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D056152 | Respiratory Rate |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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