Exercise Capacity, Heart Transplantation
Conditions
Keywords
HRQoL, exercise capacity
Brief summary
A prospective, interventional rehabilitation program was initiated to improve exercise tolerance and psychosocial functioning in patients after heart transplantation (HTx) 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 HTx. 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.
Interventions
BEHAVIORALexercise training; psychosocial support
supervised home-based endurance training; recommendation to exercise every other day
Sponsors
Roche Pharma AG
Hannover Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
Yes
Inclusion criteria
Heart transplant (6-9 mts post Tx) stabile 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
* TVP diagnosis before study inclusion * Episodes of recurrent acute rejections * Medical contra-indication for regular exercise ergometer training * Malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HRQoL,exercise capacity | 36 mts |
Secondary
| Measure | Time frame |
|---|---|
| Weight gain; cardiovascular risk factors; social re-integration | 36 mts |
Outcome results
None listed