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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02113748
Other study ID # ML10278
Secondary ID
Status Recruiting
Phase N/A
First received April 8, 2014
Last updated April 11, 2014
Start date April 2014

Study information

Verified date April 2014
Source Katholieke Universiteit Leuven
Contact Thierry Troosters, PhD
Email Thierry.Troosters@kuleuven.be
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial Summary

This randomized control trial will investigate whether a modality that generates more contractile muscle fatigue with lower ventilatory requirements render better results after a 12-week exercise training program in subjects with COPD.

Subjects will be randomized to either exercise in a training program including downhill walking or to exercise in a training program including conventional walking.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with a primary diagnosis of COPD according to internationally accepted guidelines

- Patients referred to the outpatient PR program of Gasthuisberg University Hospital(Leuven, Belgium)

Exclusion Criteria:

- Any underlying disease or musculoskeletal limitation that could impair the ability to perform any of the exercise training modalities

- Absence of exacerbations in the previous month before entering the present study

- Patients included on the waiting list for lung transplantation

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Downhill walking training
Walk on a treadmill with a negative inclination.
Conventional walking training
Walk on a treadmill without inclination. Possible to progress training intensity with positive inclinations

Locations

Country Name City State
Belgium University Hospitals Leuven Leuven Vl-Brabant

Sponsors (3)

Lead Sponsor Collaborator
Katholieke Universiteit Leuven Conselho Nacional de Desenvolvimento Científico e Tecnológico, Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in 6-minute walking distance changes from baseline to Week 12 No
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