- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02613351
Muscle Activity and Sensation During Upright Partitioned Leg Exercise in COPD (MAPLE)
November 16, 2017 updated by: Roger Goldstein, West Park Healthcare Centre
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6M 2J5
- Westpark Health Care Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: scooting
incremental test to establish the relationship between leg and breathing heaviness with increasing demand (speed) during scooting
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
slope of the relationship between self-reported breathing and leg heaviness using Borg scale
Time Frame: 1 week
|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
August 14, 2017
Study Completion (Actual)
August 14, 2017
Study Registration Dates
First Submitted
November 17, 2015
First Submitted That Met QC Criteria
November 19, 2015
First Posted (Estimate)
November 24, 2015
Study Record Updates
Last Update Posted (Actual)
November 20, 2017
Last Update Submitted That Met QC Criteria
November 16, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WPHC-RG-1Lscoot20151201
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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