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NCT00753155 Clinical Trial

Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lung Transplantation (Ergo-LTx)

Lung Transplantation Clinical Trial

— Ergo-LTx  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00753155
Other study ID # LTx-2778
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 12, 2008
Last updated September 15, 2008
Start date January 2002
Est. completion date September 2009

Study information
Verified date September 2008
Source Hannover Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 89
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 67 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Behavioral:
• exercise training; psychosocial support
supervised home-based endurance training; recommendation to exercise every other day; psychosocial support

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Hannover Medical School Roche Pharma AG

Outcome
Type Measure Description Time frame Safety issue
Primary HRQoL, exercise capacity 36 mts No
Secondary Weight gain; Pulmonary function; Social re-integration 36 mts No
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