Overview

This trial is active, not recruiting.

Condition lung transplantation
Treatment exercise training; psychosocial support
Sponsor Hannover Medical School
Collaborator Roche Pharma AG
Start date January 2002
End date September 2009
Trial size 89 participants
Trial identifier NCT00753155, LTx-2778

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care

Primary Outcomes

Measure
HRQoL, exercise capacity
time frame: 36 mts

Secondary Outcomes

Measure
Weight gain; Pulmonary function; Social re-integration
time frame: 36 mts

Eligibility Criteria

Male or female participants from 18 years up to 67 years old.

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

Additional Information

Official title Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lnug Transplantation
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by Hannover Medical School.