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

NCT00752336 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2008-09-15

No results posted yet for this study

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.

Conditions

  • Exercise Capacity
  • Heart Transplantation

Interventions

BEHAVIORAL

exercise training; psychosocial support

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Hannover Medical School

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2009-09-30
Completion
2009-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00752336 on ClinicalTrials.gov