Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects
Recruitment status was: Recruiting
|Pulmonary Arterial Hypertension Eisenmenger Syndrome||Other: respiratory and exercise therapy||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life in Patients With Severe Associated Pulmonary Arterial Hypertension (APAH) as Part of a Congenital Heart Defect With / Without Eisenmenger's Syndrome|
- Changes in the maximum 6-minute walk distance (6MGT) [ Time Frame: up to 15 weeks ]
- Changes in quality of life [ Time Frame: up to 15 weeks ]
- Changes in hemodynamics [ Time Frame: up to 15 weeks ]
- Changes in maximum oxygen uptake
- Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2)
- Improved condition(NYHA class, Borg scale)
- Changes in Magnetic resonance tomography and echocardiographic parameters of right and left ventricle: size and pump function.
- Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Respiratory and exercise therapy
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.
Other: respiratory and exercise therapy
Conventional therapy with specific respiratory and physical therapy plus mental walking training
No Intervention: Control group without exercise training
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397110
|Contact: Ekkehard Gruenig, MD||+49 6221 396 firstname.lastname@example.org|
|: Center for pulmonary Hypertension, Thoraxclinic Heidelberg||Recruiting|
|Heidelberg, Germany, 69126|
|Principal Investigator: Ekkehard Gruenig, MD|
|Study Chair:||Ekkehard Gruenig, MD||Center for pulmonary hypertension, Thoraxclinic Heidelberg|