NCT00759538

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

Same day

First QC Date

September 24, 2008

Last Update Submit

July 30, 2012

Conditions

Keywords

Lung TransplantationPulmonary RehabilitationExercise toleranceQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Exercise capacity at the end of an early short-term after lung transplantation

    3 years

Secondary Outcomes (4)

  • Lung function

    3 years

  • Body composition

    3 years

  • Activities of daily living

    3 years

  • Health Status (SF-36)

    3 years

Study Arms (1)

1

lung transplant patients performing a three week lasting rehabilitation program

Eligibility Criteria

Age17 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

lung transplant patients performing a three week lasting rehabilitation program

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School, Dpt. of Respiratory Medicine

Hanover, Germany

Location

Related Publications (5)

  • Tegtbur U, Sievers C, Busse MW, Pethig K, Warnecke G, Kugler C, Gutzlaff E, Kunsebeck HW, Struber M, Haverich A, Niedermeyer J. [Quality of life and exercise capacity in lung transplant recipients]. Pneumologie. 2004 Feb;58(2):72-8. doi: 10.1055/s-2003-812526. German.

    PMID: 14961434BACKGROUND
  • Schwaiblmair M, Reichenspurner H, Muller C, Briegel J, Furst H, Groh J, Reichart B, Vogelmeier C. Cardiopulmonary exercise testing before and after lung and heart-lung transplantation. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1277-83. doi: 10.1164/ajrccm.159.4.9805113.

    PMID: 10194177BACKGROUND
  • Schultz K, Bergmann KC, Kenn K, Petro W, Heitmann RH, Fischer R, Lang SM. [Effectiveness of inpatient pulmonary rehabilitation (AHB). Results of a multicenter prospective observation study]. Dtsch Med Wochenschr. 2006 Aug 18;131(33):1793-8. doi: 10.1055/s-2006-949155. German.

    PMID: 16902901BACKGROUND
  • Maury G, Langer D, Verleden G, Dupont L, Gosselink R, Decramer M, Troosters T. Skeletal muscle force and functional exercise tolerance before and after lung transplantation: a cohort study. Am J Transplant. 2008 Jun;8(6):1275-81. doi: 10.1111/j.1600-6143.2008.02209.x. Epub 2008 Apr 29.

    PMID: 18444941BACKGROUND
  • Dierich M, Tecklenburg A, Fuehner T, Tegtbur U, Welte T, Haverich A, Warnecke G, Gottlieb J. The influence of clinical course after lung transplantation on rehabilitation success. Transpl Int. 2013 Mar;26(3):322-30. doi: 10.1111/tri.12048. Epub 2013 Jan 7.

Study Officials

  • Martin Dierich, MD

    Hannover Medical School, Dpt. of Respiratory Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

July 1, 2007

Primary Completion

July 1, 2007

Study Completion

December 1, 2008

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations