Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life
Pulmonary Hypertension: Efficacy of Rehabilitation
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- Exercise capacity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Body composition (bioimpedance analysis)
- Health related Quality of Life [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Health related Quality of Life (Short form 36 questionnaire)
- Right ventricular function [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Activities of daily living (Barthel`s Index)
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650857
|Contact: Martin G Dierich, MD||+49 532 firstname.lastname@example.org|
|Contact: Thomas Fuehner, MD||+ 49 532 email@example.com|
|Klinik Bad Fallingbostel||Recruiting|
|Bad Fallingbostel, Lower Saxony, Germany, 29683|
|Contact: Martin G Dierich, MD +49 5162 44 754 firstname.lastname@example.org|
|Principal Investigator: Martin G Dierich, MD|
|Principal Investigator:||Martin G Dierich, MD||Department of Respiratory Diseases, Hannover Medical School|