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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 : Unknown
Verified August 2015 by Martin G Dierich, MD, Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : July 26, 2012
Last Update Posted : August 20, 2015
Sponsor:
Collaborator:
Klinik Bad Fallingbostel
Information provided by (Responsible Party):
Martin G Dierich, MD, Hannover Medical School

Study Description
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Brief Summary:
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 or disease
Pulmonary Hypertension: Efficacy of Rehabilitation

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
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
Study Start Date : April 2010
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Body composition [ Time Frame: 3 weeks ]
    Body composition (bioimpedance analysis)


Other Outcome Measures:
  1. Health related Quality of Life [ Time Frame: 3 weeks ]
    Health related Quality of Life (Short form 36 questionnaire)

  2. 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)

  3. Activities of daily living [ Time Frame: 3 weeks ]
    Activities of daily living (Barthel's Index)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Contacts
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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
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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
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Principal Investigator: Martin G Dierich, MD Department of Respiratory Diseases, Hannover Medical School
More Information
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Publications:

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Responsible Party: Martin G Dierich, MD, MD, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01650857    
Other Study ID Numbers: HannoverMS PH-Reha001
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015
Keywords provided by Martin G Dierich, MD, Hannover Medical School:
Pulmonary hypertension
Rehabilitation
Exercise capacity
Body composition
Health related Quality of Life
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases