Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lung Transplantation (Ergo-LTx)
Not Applicable
- Conditions
- Lung Transplantation
- Registration Number
- NCT00753155
- Lead Sponsor
- Hannover Medical School
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 89
Inclusion Criteria
- 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
Exclusion Criteria
- BOS III diagnosis before study inclusion
- Episodes of recurrent acute rejections
- Medical contra-indication for regular exercise ergometer training
- Malignancy
- Multi-resistent pathogens
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HRQoL, exercise capacity 36 mts
- Secondary Outcome Measures
Name Time Method Weight gain; Pulmonary function; Social re-integration 36 mts