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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00753155
Acronym
Ergo-LTx
Enrollment
89
Registered
2008-09-16
Start date
2002-01-31
Completion date
2009-09-30
Last updated
2008-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplantation

Keywords

HRQoL;, exercise, capacity

Brief 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.

Interventions

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

Sponsors

Roche Pharma AG
CollaboratorINDUSTRY
Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
HRQoL, exercise capacity36 mts

Secondary

MeasureTime frame
Weight gain; Pulmonary function; Social re-integration36 mts

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026