Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lung Transplantation (Ergo-LTx)
Ergo-LTx
1 other identifier
interventional
89
0 countries
N/A
Brief Summary
A prospective, interventional rehabilitation program was initiated to improve exercise capacity and psychosocial functioning in patients after lung transplantation (LTx) and to evaluate long-term effects on health-related quality of life (HRQoL). Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after LTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2002
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2008
CompletedFirst Posted
Study publicly available on registry
September 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedSeptember 16, 2008
September 1, 2008
7.7 years
September 12, 2008
September 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HRQoL, exercise capacity
36 mts
Secondary Outcomes (1)
Weight gain; Pulmonary function; Social re-integration
36 mts
Interventions
supervised home-based endurance training; recommendation to exercise every other day; psychosocial support
Eligibility Criteria
You may qualify if:
- Lung transplant (single, double, combined heart-lung) (6-9 mts post Tx)
- Stable health condition at study entry (pt stays within home environment)
- Age ≥ 18 yrs
- Sufficient language skills to answer questionnaire
- Follow-up at our center
- Willingness to participate by written informed consent
You may not qualify if:
- Episodes of recurrent acute rejections
- Medical contra-indication for regular exercise ergometer training
- Malignancy
- Multi-resistent pathogens
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hannover Medical Schoollead
- Roche Pharma AGcollaborator
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2008
First Posted
September 16, 2008
Study Start
January 1, 2002
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
September 16, 2008
Record last verified: 2008-09