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Effect of Early Pulmonary Rehabilitation After Lung Transplantation

This study has been completed.
Sponsor:
Collaborator:
Klinik Fallingbostel Rehabilitation Center
Information provided by (Responsible Party):
Martin G Dierich, MD, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00759538
First received: September 24, 2008
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Lung Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Early Pulmonary Rehabilitation After Lung Transplantation in Patients With a Prolonged Length of Stay on the Waiting List and Hospitalization After Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Exercise capacity at the end of an early short-term after lung transplantation [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung function [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Activities of daily living [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Health Status (SF-36) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
lung transplant patients performing a three week lasting rehabilitation program

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.
  Eligibility

Ages Eligible for Study:   17 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

lung transplant patients performing a three week lasting rehabilitation program

Criteria

Inclusion Criteria:

  • Recipients of single or double lung transplants
  • Recipients of combined (heart and lung or heart an liver) transplants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759538

Locations
Germany
Hannover Medical School, Dpt. of Respiratory Medicine
Hannover, Germany
Sponsors and Collaborators
Hannover Medical School
Klinik Fallingbostel Rehabilitation Center
Investigators
Principal Investigator: Martin Dierich, MD Hannover Medical School, Dpt. of Respiratory Medicine
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Martin G Dierich, MD, MD, Hannover Medical School
ClinicalTrials.gov Identifier: NCT00759538     History of Changes
Other Study ID Numbers: MHH-2008-4
Study First Received: September 24, 2008
Last Updated: July 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Lung Transplantation
Pulmonary Rehabilitation
Exercise tolerance
Quality of Life

ClinicalTrials.gov processed this record on May 22, 2013