Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lung Transplantation (Ergo-LTx)
This trial is active, not recruiting.
|Treatment||exercise training; psychosocial support|
|Sponsor||Hannover Medical School|
|Collaborator||Roche Pharma AG|
|Start date||January 2002|
|End date||September 2009|
|Trial size||89 participants|
|Trial identifier||NCT00753155, LTx-2778|
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.
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
HRQoL, exercise capacity
time frame: 36 mts
Weight gain; Pulmonary function; Social re-integration
time frame: 36 mts
Male or female participants from 18 years up to 67 years old.
- 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
- BOS III diagnosis before study inclusion
- Episodes of recurrent acute rejections
- Medical contra-indication for regular exercise ergometer training
- Multi-resistent pathogens
|Official title||Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lnug Transplantation|
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