Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation
This trial is active, not recruiting.
|Conditions||exercise capacity, heart transplantation|
|Treatment||exercise training; psychosocial support|
|Sponsor||Hannover Medical School|
|Collaborator||Roche Pharma AG|
|Start date||January 2002|
|End date||September 2009|
|Trial size||87 participants|
|Trial identifier||NCT00752336, HTx-2777|
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.
|Intervention model||parallel assignment|
|Primary purpose||supportive care|
time frame: 36 mts
Weight gain; cardiovascular risk factors; social re-integration
time frame: 36 mts
Male or female participants from 18 years up to 67 years old.
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
|Official title||Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation|
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