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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Exercise Capacity Heart Transplantation

Keywords

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HRQoL exercise capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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exercise training; psychosocial support

supervised home-based endurance training; recommendation to exercise every other day

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Hannover Medical School, Hannover

Other Identifiers

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HTx-2777

Identifier Type: -

Identifier Source: org_study_id