NCT00395889

Brief Summary

The purpose of this study is to compare participation in physical activities in daily life and functional outcomes of lung transplant recipients attending a six-month multicomponent rehabilitation program including exercise training against others receiving only instructions on how to increase their participation in physical activities in daily life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_1

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

November 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

4 years

First QC Date

November 3, 2006

Last Update Submit

February 18, 2011

Conditions

Lung Transplantation

Keywords

Lung TransplantationPhysical Activities in Daily LifePulmonary RehabilitationFunctional Status

Outcome Measures

Primary Outcomes (1)

  • Participation in Physical Activities in Daily Life

    One year

Secondary Outcomes (4)

  • Health Status (SF-36)

    One year

  • Exercise Capacity

    One year

  • Peripheral Muscle Function

    One year

  • Psychological Functioning

    One year

Study Arms (2)

Rehabilitation + Lifestyle Counseling

EXPERIMENTAL

Multicomponent Pulmonary Rehabilitation Program including structured exercise training

Procedure: Rehabilitation including structured exercise training

Lifestyle Counseling

ACTIVE COMPARATOR
Procedure: Physical Activity Counseling

Interventions

Rehabilitation including structured exercise trainingPROCEDURE

Rehabilitation of at least 8 weeks, for at least twice/week. This group will also receive the exercise counseling as a part of the rehabilitation program.

Also known as: Physical Activity Counseling, Pulmonary Rehabilitation
Rehabilitation + Lifestyle Counseling
Physical Activity CounselingPROCEDURE

Six exercise counseling sessions will be carried out during a 6-month period. This group will only receive the counseling and no formal structured exercise training sessions.

Lifestyle Counseling

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipients of single or double lung transplants

You may not qualify if:

  • Recipients of multiple organ transplants
  • Patients scheduled for retransplantation
  • Patients not leaving hospital within 6 weeks after surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, B-3000, Belgium

Location

Related Publications (1)

  • Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.

    PMID: 34282853DERIVED

Study Officials

  • Daniel Langer, MSc

    KU-Leuven, Faculty of Movement and Rehabilitation Sciences

    PRINCIPAL INVESTIGATOR

  • Rik Gosselink, PhD

    KU-Leuven, Faculty of Movement and Rehabilitation Sciences

    STUDY CHAIR

  • Thierry Troosters, PhD

    KU-Leuven, Faculty of Movement and Rehabilitation Sciences

    STUDY CHAIR

  • Marc Decramer, PhD

    University Hospital Leuven, Respiratory Division

    STUDY CHAIR

  • Geert Verleden, PhD

    University Hospital Leuven, Respiratory Division

    STUDY CHAIR

  • Lieven Dupont, PhD

    University Hospital Leuven, Respiratory Division

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2006

First Posted

November 6, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

February 21, 2011

Record last verified: 2011-02

Locations

BE(1)