Physical Activities in Daily Life After Lung Transplantation
NCT ID: NCT00395889
Last Updated: 2011-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2006-11-30
2010-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Early Pulmonary Rehabilitation After Lung Transplantation
NCT00759538
High-intensity Training Safely Improves Exercise Capacity in Heart, Lung, Kidney, and Liver Transplant Recipients: a Comparative Study
NCT03329586
Heart Transplant Patients, Health Status and Physical Activity
NCT05282342
Rehabilitation for Patients With Pulmonary Hypertension
NCT03955016
Empowerment of Lung and Heart-lung Transplant Patients
NCT00808600
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Interventions: Both groups will receive counseling to engage in regular physical activity. Patients in the intervention group will additionally follow a standardized outpatient pulmonary rehabilitation program for 6 months starting immediately after discharge from hospital.
* Hypothesis: Our alternative hypothesis is that intensive post transplant rehabilitation does enhance improvements in functional status and participation in physical activities in daily life after transplantation.
* Outcomes: Participation in physical activities in daily life will be the primary outcome. Physical component summary scale of the SF-36, exercise capacity and peripheral muscle function will be secondary outcomes. Outcomes will be assessed on discharge from the hospital and again three, six and twelve months after discharge.
* Treatment failure: Patients in the control group receiving only counseling will be allowed to discontinue the assigned treatment and will receive respiratory rehabilitation including exercise training if functional outcomes do not improve or participation in physical activities in daily life does not increase within the first three months of the intervention period. The treatment groups will be compared both as randomized (according to intention to treat) and with crossover cases excluded.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rehabilitation + Lifestyle Counseling
Multicomponent Pulmonary Rehabilitation Program including structured exercise training
Rehabilitation including structured exercise training
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.
Lifestyle Counseling
Physical Activity Counseling
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rehabilitation including structured exercise training
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.
Physical Activity Counseling
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients scheduled for retransplantation
* Patients not leaving hospital within 6 weeks after surgery
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fund for Scientific Research, Flanders, Belgium
OTHER
International Society for Heart and Lung Transplantation
OTHER
KU Leuven
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
KU Leuven
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Langer, MSc
Role: PRINCIPAL_INVESTIGATOR
KU-Leuven, Faculty of Movement and Rehabilitation Sciences
Rik Gosselink, PhD
Role: STUDY_CHAIR
KU-Leuven, Faculty of Movement and Rehabilitation Sciences
Thierry Troosters, PhD
Role: STUDY_CHAIR
KU-Leuven, Faculty of Movement and Rehabilitation Sciences
Marc Decramer, PhD
Role: STUDY_CHAIR
University Hospital Leuven, Respiratory Division
Geert Verleden, PhD
Role: STUDY_CHAIR
University Hospital Leuven, Respiratory Division
Lieven Dupont, PhD
Role: STUDY_CHAIR
University Hospital Leuven, Respiratory Division
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Leuven
Leuven, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML3782
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.