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

Hannover Medical School87 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Exercise Capacity Heart Transplantation

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 67 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

HRQoL,exercise capacity

Time frame: 36 mts

Secondary Outcomes

Weight gain; cardiovascular risk factors; social re-integration

Time frame: 36 mts