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Clinical Trials/NCT00753155
NCT00753155
Unknown
Not Applicable

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

Hannover Medical School0 sites89 target enrollmentJanuary 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Transplantation
Sponsor
Hannover Medical School
Enrollment
89
Primary Endpoint
HRQoL, exercise capacity
Last Updated
17 years ago

Overview

Brief Summary

A prospective, interventional rehabilitation program was initiated to improve exercise capacity and psychosocial functioning in patients after lung transplantation (LTx) 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 LTx. 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.

Registry
clinicaltrials.gov
Start Date
January 2002
End Date
September 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Lung transplant (single, double, combined heart-lung) (6-9 mts post Tx)
  • Stable 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

  • BOS III diagnosis before study inclusion
  • Episodes of recurrent acute rejections
  • Medical contra-indication for regular exercise ergometer training
  • Malignancy
  • Multi-resistent pathogens

Outcomes

Primary Outcomes

HRQoL, exercise capacity

Time Frame: 36 mts

Secondary Outcomes

  • Weight gain; Pulmonary function; Social re-integration(36 mts)

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