Back to resultsDownhill Walking Training in COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Downhill walking training
Conventional walking training
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary disease, chronic obstructive, Downhill walking, exercise
Eligibility Criteria
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
Sites / Locations
- University Hospitals LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Downhill walking training
Conventional walking training
Arm Description
Exercise training including treadmill walking with a negative inclination.
Exercise training including treadmill walking without inclination. Possible to progress training intensity with positive inclinations.
Outcomes
Primary Outcome Measures
changes in 6-minute walking distance
Secondary Outcome Measures
Full Information
NCT ID
NCT02113748
First Posted
April 8, 2014
Last Updated
April 11, 2014
Sponsor
KU Leuven
Collaborators
Research Foundation Flanders, Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT02113748
Brief Title
Downhill Walking Training in COPD
Official Title
Downhill Walking to Enhance Training Effects in Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Research Foundation Flanders, Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary disease, chronic obstructive, Downhill walking, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Downhill walking training
Arm Type
Experimental
Arm Description
Exercise training including treadmill walking with a negative inclination.
Arm Title
Conventional walking training
Arm Type
Active Comparator
Arm Description
Exercise training including treadmill walking without inclination. Possible to progress training intensity with positive inclinations.
Intervention Type
Other
Intervention Name(s)
Downhill walking training
Intervention Description
Walk on a treadmill with a negative inclination.
Intervention Type
Other
Intervention Name(s)
Conventional walking training
Intervention Description
Walk on a treadmill without inclination. Possible to progress training intensity with positive inclinations
Primary Outcome Measure Information:
Title
changes in 6-minute walking distance
Time Frame
changes from baseline to Week 12
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry Troosters, PhD
Email
Thierry.Troosters@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Troosters, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vl-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Troosters, PhD
Email
Thierry.Troosters@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Carlos Augusto Camillo, MSc
First Name & Middle Initial & Last Name & Degree
Thierry Troosters, PhD
First Name & Middle Initial & Last Name & Degree
Wim Janssens, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
32444407
Citation
Camillo CA, Osadnik CR, Burtin C, Everaerts S, Hornikx M, Demeyer H, Loeckx M, Rodrigues FM, Maes K, Gayan-Ramirez G, Janssens W, Troosters T. Effects of downhill walking in pulmonary rehabilitation for patients with COPD: a randomised controlled trial. Eur Respir J. 2020 Sep 17;56(3):2000639. doi: 10.1183/13993003.00639-2020. Print 2020 Sep.
Results Reference
derived
Learn more about this trial
Downhill Walking Training in COPD
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