- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02527655
The Men on the Move Study
September 19, 2018 updated by: Dawn C. Mackey, Simon Fraser University
Shape the Path: Targeting the Health and Mobility of Older Men Through Key Community Partnerships -- The Men on the Move Study
The Men on the Move Study is a randomized, controlled, feasibility study designed to address the health problem of physical inactivity in older men.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Men on the Move is a randomized, controlled, feasibility study to provide preliminary evidence of feasibility and efficacy for promoting mobility through the uptake of physical activity among men aged 65 years and older who are physically inactive.
Specifically, Men on the Move will evaluate the effects of a choice-based physical activity model paired with an active transportation model.
The choice-based physical activity model encourages older men to use existing community-based resources to create and implement actions plans for physical activity.
It also provides ongoing face-to-face and telephone-based support from trained activity coaches.
The active transportation model provides transit passes and active travel planning to promote use of transit and walking to destinations of interest.
The feasibility of delivering the intervention will be assessed.
Accelerometry and travel diaries will be used to measure the effects of the intervention on physical activity.
Study Type
Interventional
Enrollment (Actual)
58
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
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British Columbia
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Vancouver, British Columbia, Canada, V5Z1M9
- Centre for Hip Health and Mobility
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 65 years of age and older;
- identify as a man;
- English speaking; and
- demonstrate readiness for physical activity (by the PAR-Q+ questionnaire or a letter of recommendation from their physician)
Exclusion Criteria:
- participated in any strength training in the past 3 months;
- participated in any aerobic exercise class in the past 3 months;
- live in a nursing home or assisted living facility; or
- have plans to be out of town for more than 7 days during the 12-week intervention period.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Choice-Based Physical Activity and Active Transportation
Participants will meet one-on-one with an activity coach to develop a choice-based physical activity and active transportation plan based on their interest, abilities, and resources; attend group-based motivational meetings; and receive ongoing support and encouragement for physical activity and active transportation (e.g., telephone-assisted support, community centre and transit passes).
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No Intervention: Wait-List Control
Participants will be offered the Choice-Based Physical Activity and Active Transportation intervention after the experimental arm has completed the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of participant recruitment and retention
Time Frame: 12 weeks
|
Number of study participants recruited and retained for the 12-week study
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in physical activity as measured by accelerometry at 12 weeks
Time Frame: Baseline and 12 weeks
|
Minutes/day
|
Baseline and 12 weeks
|
Change from baseline in daily steps as measured by accelerometry at 12 weeks
Time Frame: Baseline and 12 weeks
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steps/day
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Baseline and 12 weeks
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Change from baseline in physical activity as measured by the CHAMPS questionnaire score at 12 weeks
Time Frame: Baseline and 12 weeks
|
Baseline and 12 weeks
|
|
Change from baseline in active transportation as measured by travel diaries at 12 weeks
Time Frame: Baseline and 12 weeks
|
Trip rates (overall, by walking, by transit)
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Baseline and 12 weeks
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Change from baseline in mobility as measured by the Short Physical Performance Battery (SPPB) score at 12 weeks
Time Frame: Baseline and 12 weeks
|
Baseline and 12 weeks
|
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Change from baseline in mobility as measured by the Life-Space Assessment score at 12 weeks
Time Frame: Baseline and 12 weeks
|
Baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heather A McKay, PhD, University of British Columbia
- Principal Investigator: Joanie Sims-Gould, PhD, University of British Columbia
- Principal Investigator: Meghan Winters, PhD, Simon Fraser University
- Principal Investigator: Christiane Hoppmann, PhD, University of British Columbia
- Principal Investigator: Alison Phinney, PhD, University of British Columbia
- Principal Investigator: Karim Khan, PhD, University of British Columbia
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
August 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
July 29, 2015
First Submitted That Met QC Criteria
August 17, 2015
First Posted (Estimate)
August 19, 2015
Study Record Updates
Last Update Posted (Actual)
September 20, 2018
Last Update Submitted That Met QC Criteria
September 19, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STP-MOTM
- TE1-138295 (Other Grant/Funding Number: Canadian Institutes of Health Research)
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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