- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02113748
Downhill Walking Training in COPD
Downhill Walking to Enhance Training Effects in Patients With COPD
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vl-Brabant
-
Leuven, Vl-Brabant, Belgium, 3000
- Recruiting
- University Hospitals Leuven
-
Principal Investigator:
- Thierry Troosters, PhD
-
Sub-Investigator:
- Carlos Augusto Camillo, MSc
-
Principal Investigator:
- Wim Janssens, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Downhill walking training
Exercise training including treadmill walking with a negative inclination.
|
Walk on a treadmill with a negative inclination.
|
|
Active Comparator: Conventional walking training
Exercise training including treadmill walking without inclination.
Possible to progress training intensity with positive inclinations.
|
Walk on a treadmill without inclination.
Possible to progress training intensity with positive inclinations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
changes in 6-minute walking distance
Time Frame: changes from baseline to Week 12
|
changes from baseline to Week 12
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML10278
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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