Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01397110|
Recruitment Status : Unknown
Verified June 2015 by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University.
Recruitment status was: Recruiting
First Posted : July 19, 2011
Last Update Posted : June 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension Eisenmenger Syndrome||Other: respiratory and exercise therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397110
|Contact: Ekkehard Gruenig, MD||+49 6221 396 email@example.com|
|: 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|