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The Men on the Move Study

Primary Purpose

Physical Inactivity, Mobility Limitation, Older Men

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Choice-Based Physical Activity and Active Transportation

About this trial

This is an interventional treatment trial for Physical Inactivity

Eligibility Criteria

65 Years - undefined (Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Centre for Hip Health and Mobility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Choice-Based Physical Activity and Active Transportation

Wait-List Control

Arm Description

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).

Participants will be offered the Choice-Based Physical Activity and Active Transportation intervention after the experimental arm has completed the study.

Outcomes

Primary Outcome Measures

Feasibility of participant recruitment and retention

Number of study participants recruited and retained for the 12-week study

Secondary Outcome Measures

Change from baseline in physical activity as measured by accelerometry at 12 weeks

Minutes/day

Change from baseline in daily steps as measured by accelerometry at 12 weeks

steps/day

Change from baseline in physical activity as measured by the CHAMPS questionnaire score at 12 weeks

Change from baseline in active transportation as measured by travel diaries at 12 weeks

Trip rates (overall, by walking, by transit)

Change from baseline in mobility as measured by the Short Physical Performance Battery (SPPB) score at 12 weeks

Change from baseline in mobility as measured by the Life-Space Assessment score at 12 weeks

Full Information

NCT ID

NCT02527655

First Posted

July 29, 2015

Last Updated

September 19, 2018

Sponsor

Simon Fraser University

Collaborators

Canadian Institutes of Health Research (CIHR), Centre for Hip Health and Mobility

1. Study Identification

Unique Protocol Identification Number

NCT02527655

Brief Title

The Men on the Move Study

Official Title

Shape the Path: Targeting the Health and Mobility of Older Men Through Key Community Partnerships -- The Men on the Move Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Simon Fraser University

Collaborators

Canadian Institutes of Health Research (CIHR), Centre for Hip Health and Mobility

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The Men on the Move Study is a randomized, controlled, feasibility study designed to address the health problem of physical inactivity in older men.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Physical Inactivity, Mobility Limitation, Older Men

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Choice-Based Physical Activity and Active Transportation

Arm Type

Experimental

Arm Description

Arm Title

Wait-List Control

Arm Type

No Intervention

Arm Description

Participants will be offered the Choice-Based Physical Activity and Active Transportation intervention after the experimental arm has completed the study.

Intervention Type

Behavioral

Intervention Name(s)

Choice-Based Physical Activity and Active Transportation

Primary Outcome Measure Information:

Title

Feasibility of participant recruitment and retention

Description

Number of study participants recruited and retained for the 12-week study

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in physical activity as measured by accelerometry at 12 weeks

Description

Minutes/day

Time Frame

Baseline and 12 weeks

Title

Change from baseline in daily steps as measured by accelerometry at 12 weeks

Description

steps/day

Time Frame

Baseline and 12 weeks

Title

Change from baseline in physical activity as measured by the CHAMPS questionnaire score at 12 weeks

Time Frame

Baseline and 12 weeks

Title

Change from baseline in active transportation as measured by travel diaries at 12 weeks

Description

Trip rates (overall, by walking, by transit)

Time Frame

Baseline and 12 weeks

Title

Change from baseline in mobility as measured by the Short Physical Performance Battery (SPPB) score at 12 weeks

Time Frame

Baseline and 12 weeks

Title

Change from baseline in mobility as measured by the Life-Space Assessment score at 12 weeks

Time Frame

Baseline and 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: