Back to resultsMuscle Activity and Sensation During Upright Partitioned Leg Exercise in COPD (MAPLE)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
scooting
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Exercise Tolerance, Lung Diseases, Obstructive
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COPD: FEV1 < 80 % and FEV1/FVC < 0.7;
- Able to communicate in English
- Clinically stable
Exclusion Criteria:
- predominant co-morbidities or treatments that might influence the results of exercise testing
Sites / Locations
- Westpark Health Care Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
scooting
Arm Description
incremental test to establish the relationship between leg and breathing heaviness with increasing demand (speed) during scooting
Outcomes
Primary Outcome Measures
slope of the relationship between self-reported breathing and leg heaviness using Borg scale
Borg scale ratings of breathing and leg heaviness will be measured during stepwise incremental speed exercise tests. The relationship between leg and breathing heaviness with increasing demand (speed) is quantified by the slope of the relationship between self-reported breathing and leg heaviness under each condition of customary walking and scooting.
Secondary Outcome Measures
Full Information
NCT ID
NCT02613351
First Posted
November 17, 2015
Last Updated
November 16, 2017
Sponsor
West Park Healthcare Centre
1. Study Identification
Unique Protocol Identification Number
NCT02613351
Brief Title
Muscle Activity and Sensation During Upright Partitioned Leg Exercise in COPD
Acronym
MAPLE
Official Title
Leg Muscle Activity and Sensation During Upright Partitioned Exercise Compared to Walking: Propulsion of a 3-wheeled Scooter by Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
August 14, 2017 (Actual)
Study Completion Date
August 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Park Healthcare Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to determine if: the large muscles of the leg, activated during walking, are also active during scooting; whether scooting alters the relationship between leg and breathing heaviness; whether there is evidence of leg fatigue during scooting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Exercise Tolerance, Lung Diseases, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
scooting
Arm Type
Experimental
Arm Description
incremental test to establish the relationship between leg and breathing heaviness with increasing demand (speed) during scooting
Intervention Type
Device
Intervention Name(s)
scooting
Intervention Description
three-wheeled scooter (Monark 662, Monark Exercise AB Sweden) comprised of a single front wheel that provides steering and two rear wheels that create a wide base of support.
Primary Outcome Measure Information:
Title
slope of the relationship between self-reported breathing and leg heaviness using Borg scale
Description
Borg scale ratings of breathing and leg heaviness will be measured during stepwise incremental speed exercise tests. The relationship between leg and breathing heaviness with increasing demand (speed) is quantified by the slope of the relationship between self-reported breathing and leg heaviness under each condition of customary walking and scooting.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD: FEV1 < 80 % and FEV1/FVC < 0.7;
Able to communicate in English
Clinically stable
Exclusion Criteria:
predominant co-morbidities or treatments that might influence the results of exercise testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger S Goldstein, MD
Organizational Affiliation
West Park Healthcare Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westpark Health Care Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Muscle Activity and Sensation During Upright Partitioned Leg Exercise in COPD
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