Effect of Early Pulmonary Rehabilitation After Lung Transplantation

July 30, 2012 updated by: Martin G Dierich, MD, Hannover Medical School

Effect of Early Pulmonary Rehabilitation After Lung Transplantation in Patients With a Prolonged Length of Stay on the Waiting List and Hospitalization After Transplantation

The purpose of this observation study is to evaluate the effects of an early, 3 week lasting rehabilitation program, that starts roundabout 4 weeks after lung or combined lung transplantation, on physical activity, functional and physical condition (6-min-walk, FEV1, ADL-score) and quality of life (SF36) in lung transplant recipients with a different length of stay on the waiting list and a different duration of hospitalization in the transplantation centre after transplantation.

Study Overview

Status

Completed

Conditions

Detailed Description

To which extend a prolonged duration from listing for lung transplantation until a successful transplantation or a long length of hospitalization may influence the success of a pulmonary rehabilitation, that starts after discharge from the transplantation centre, is still unknown.

Long waiting periods before transplantation and surgical, infectious or immunological complications after transplantation influence the physical condition and the quality of life of the organ recipient.

A poor physical condition before transplantation results in an unfavourable outcome in the first 12 months after transplantation.

At present it is unclear, whether a structured pulmonary rehabilitation may overwhelm differences between patients with a prolonged course roundabout the transplantation compared or not. At present it is not clear whether it is necessary for lung transplant recipients to participate in a rehabilitation program including structured exercise training.

The aim of this observational study is to assess the effect of a short-term pulmonary rehabilitation, that starts immediately after discharge from the transplantation centre on patients with a prolonged waiting period or an extended postoperative hospitalization.

  • Hypothesis: a structured pulmonary rehabilitation early after transplantation may overwhelm poor physical and functional conditions after a prolonged period on the transplant waiting listor a prolonged hospitalization after transplantation resulting in a significant improvement in all transplanted patients
  • Antithesis: a prolonged period on the waiting list before transplantation or a prolonged hospitalization after transplantation can not be influenced significantly by an early transplant rehabilitation resulting in a persistent lack of functional status and quality of life compared with a short waiting period or a normal duration of hospitalization after transplantation.
  • Outcomes: functional status (6-min. walk, exercise capacity, FEV1, ADL), and quality of life (SF36) will be assessed at the beginning and on discharge from the rehabilitation centre.

Study Type

Observational

Enrollment (Actual)

120

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
      • Hannover, Germany
        • Hannover Medical School, Dpt. of Respiratory Medicine

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

17 years to 67 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

lung transplant patients performing a three week lasting rehabilitation program

Description

Inclusion Criteria:

  • Recipients of single or double lung transplants
  • Recipients of combined (heart and lung or heart an liver) transplants

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

Cohorts and Interventions

Group / Cohort
1
lung transplant patients performing a three week lasting rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise capacity at the end of an early short-term after lung transplantation
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Lung function
Time Frame: 3 years
3 years
Body composition
Time Frame: 3 years
3 years
Activities of daily living
Time Frame: 3 years
3 years
Health Status (SF-36)
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Hannover Medical School

Collaborators

Klinik Fallingbostel Rehabilitation Center

Investigators

  • Principal Investigator: Martin Dierich, MD, Hannover Medical School, Dpt. of Respiratory Medicine

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

July 1, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MHH-2008-4

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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