Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lnug Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hannover Medical School
- Enrollment
- 89
- Primary Endpoint
- HRQoL, exercise capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
HRQoL, exercise capacity
Time Frame: 36 mts
Secondary Outcomes
- Weight gain; Pulmonary function; Social re-integration(36 mts)