Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation (Ergo-HTx)

Hannover Medical School (MHH)

Status: Unknown

Conditions: Exercise Capacity; Heart Transplantation

Treatments: Behavioral: exercise training; psychosocial support

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00752336

HTx-2777

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)