Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life
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|ClinicalTrials.gov Identifier: NCT01650857|
Recruitment Status : Recruiting
First Posted : July 26, 2012
Last Update Posted : August 20, 2015
|Condition or disease|
|Pulmonary Hypertension: Efficacy of Rehabilitation|
Pulmonary hypertension (PH) impairs physical condition (PC), body composition (BC) and health-related quality of life (HRQOL).
Specific pharmacological treatment and - in selected patients, refractory to agents - lung or combined heart and lung transplantation can improve physical functioning and long term survival. Initial trials with limited numbers of patients were encouraging. Investigation of larger cohorts is essential to assess the efficacy of rehabilitation programmes in PH.
We hypothesize that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL in patients with PH in functional classes (FC) II and III. Critical ill patients with a functional class IV are excluded. All patients with PH undergo a 3-week inpatient rehabilitation program (interval bicycle and strength training, physiotherapy, psychological support, education). Exercise testing (peak work load (PWL) 6-min-walk distance), body composition (bioimpedance analysis BIA: lean body mass (LBM), body cell mass (BCM), BCM/LBM ratio, phase angle (PA)) and HRQOL (SF 36 questionnaire) are assessed at baseline and completion of PR.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Pulmonary Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life - an Observational Study|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
- Exercise capacity [ Time Frame: 3 weeks ]Exercise capacity (peak work load and 6-minute walk distance at completion of an 3-week inpatient pulmonary rehabilitation)
- Body composition [ Time Frame: 3 weeks ]Body composition (bioimpedance analysis)
- Health related Quality of Life [ Time Frame: 3 weeks ]Health related Quality of Life (Short form 36 questionnaire)
- Right ventricular function [ Time Frame: 3 weeks ]Right ventricular function (echocardiography: estimated right ventricular systolic pressure, Tricuspid annular plane systolic excursion, left ventricular eccentricity index)
- Activities of daily living [ Time Frame: 3 weeks ]Activities of daily living (Barthel`s Index)
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): NCT01650857
|Contact: Martin G Dierich, MD||+49 532 email@example.com|
|Contact: Thomas Fuehner, MD||+ 49 532 firstname.lastname@example.org|
|Klinik Bad Fallingbostel||Recruiting|
|Bad Fallingbostel, Lower Saxony, Germany, 29683|
|Contact: Martin G Dierich, MD +49 5162 44 754 email@example.com|
|Principal Investigator: Martin G Dierich, MD|
|Principal Investigator:||Martin G Dierich, MD||Department of Respiratory Diseases, Hannover Medical School|