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

Sponsors and Collaborators:	Hannover Medical School Hoffmann-La Roche
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT00753155

Purpose

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.

Condition	Intervention
Lung Transplantation	Behavioral: exercise training; psychosocial support

MedlinePlus related topics: Exercise and Physical Fitness Lung Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Lnug Transplantation

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:

HRQoL, exercise capacity [ Time Frame: 36 mts ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight gain; Pulmonary function; Social re-integration [ Time Frame: 36 mts ] [ Designated as safety issue: No ]

Enrollment:	89
Study Start Date:	January 2002
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 67 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Hannover Medical School, Hannover ( Kugler, Christiane, PhD )
Study ID Numbers:	LTx-2778
Study First Received:	September 12, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00753155
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:

HRQoL;
exercise
capacity

ClinicalTrials.gov processed this record on January 16, 2009