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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Transplantation

Keywords

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HRQoL; exercise capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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exercise training; psychosocial support

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Hannover Medical School, Hannover

References

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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.

Reference Type DERIVED

PMID: 34282853 (View on PubMed)

Other Identifiers

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LTx-2778

Identifier Type: -

Identifier Source: org_study_id