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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care

Primary Outcomes

HRQoL,exercise capacity
time frame: 36 mts

Secondary Outcomes

Weight gain; cardiovascular risk factors; social re-integration
time frame: 36 mts

Eligibility Criteria

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

Additional Information

Official title Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by Hannover Medical School.