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Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life

This study is currently recruiting participants.
Verified July 2012 by Hannover Medical School
Sponsor:
Collaborator:
Klinik Bad Fallingbostel
Information provided by (Responsible Party):
Martin G Dierich, MD, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01650857
First received: July 21, 2012
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

Pulmonary hypertension (PH) leads to impaired physical condition (PC), body composition (BC) and health-related quality of life (HRQOL). We hypothesized that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL.


Condition
Pulmonary Hypertension: Efficacy of Rehabilitation

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Body composition [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Body composition (bioimpedance analysis)


Other Outcome Measures:
  • 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)


Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: September 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with pulmonary hypertension in World Heart Organization functional classification classes (FC) II and III

Criteria

Inclusion Criteria:

  • Clinical diagnosis of pulmonary hypertension
  • Functional class II-III

Exclusion Criteria:

  • Functional class I and IV
  • Right heart decompensation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650857

Contacts
Contact: Martin G Dierich, MD +49 532 3530 dierich.martin@mh-hannover.de
Contact: Thomas Fuehner, MD + 49 532 3530 fuehner.thomas@mh-hannover.de

Locations
Germany
Klinik Bad Fallingbostel Recruiting
Bad Fallingbostel, Lower Saxony, Germany, 29683
Contact: Martin G Dierich, MD     +49 5162 44 754     dierich@klinik-fallingbostel.de    
Principal Investigator: Martin G Dierich, MD            
Sponsors and Collaborators
Hannover Medical School
Klinik Bad Fallingbostel
Investigators
Principal Investigator: Martin G Dierich, MD Department of Respiratory Diseases, Hannover Medical School
  More Information

Publications:

Responsible Party: Martin G Dierich, MD, MD, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01650857     History of Changes
Other Study ID Numbers: HannoverMS PH-Reha001
Study First Received: July 21, 2012
Last Updated: July 31, 2012
Health Authority: Germany: Ministry of Health

Keywords provided by Hannover Medical School:
Pulmonary hypertension
Rehabilitation
Exercise capacity
Body composition
Health related Quality of Life

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013