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

August 19, 2015 updated by: Martin G Dierich, MD, Hannover Medical School

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Bad Fallingbostel, Lower Saxony, Germany, 29683
        • Recruiting
        • Klinik Bad Fallingbostel
        • Contact:
        • Principal Investigator:
          • Martin G Dierich, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Functional class I and IV
  • Right heart decompensation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 3 weeks
Body composition (bioimpedance analysis)
3 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related Quality of Life
Time Frame: 3 weeks
Health related Quality of Life (Short form 36 questionnaire)
3 weeks
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 weeks
Activities of daily living
Time Frame: 3 weeks
Activities of daily living (Barthel's Index)
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Collaborators

Klinik Bad Fallingbostel

Investigators

  • Principal Investigator: Martin G Dierich, MD, Department of Respiratory Diseases, Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

July 21, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (ESTIMATE)

July 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HannoverMS PH-Reha001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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