Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation

Not Applicable

• Conditions: Exercise Capacity; Heart Transplantation

• Registration Number: NCT00752336
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Status Verified: 2008-09
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-12
• Last Update Submitted: 2008-09-12
• Study First Posted: 2008-09-15
• Last Update Posted: 2008-09-15
• Primary Completion: 2009-09
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 87

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

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Exclusion Criteria

• TVP diagnosis before study inclusion
• Episodes of recurrent acute rejections
• Medical contra-indication for regular exercise ergometer training
• Malignancy

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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; cardiovascular risk factors; social re-integration	36 mts