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

September 15, 2008 updated by: Hannover Medical School

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

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.

Study Overview

Status

Unknown

Conditions

Lung Transplantation

Intervention / Treatment

Behavioral: exercise training; psychosocial support

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HRQoL, exercise capacity Time Frame: 36 mts	36 mts

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight gain; Pulmonary function; Social re-integration Time Frame: 36 mts	36 mts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Collaborators

Roche Pharma AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ANTICIPATED)

September 1, 2009

Study Completion (ANTICIPATED)