- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05978336
SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nathan Wei, B.Sc.
- Phone Number: 69056 604-875-4111
- Email: nathan.wei@ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1L8
- Recruiting
- Vancouver Coastal Health Research Institute Research Pavilion
-
Contact:
- Nathan Wei, B.SC
- Phone Number: 69056 604-875-4111
- Email: cogmob.research@hiphealth.ca
-
Principal Investigator:
- Teresa Liu-Ambrose, Ph.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- scored ≤ 9/12 on the SPPB
- are able to complete the 400-m walk in ≤ 15 minutes without sitting or physical assistance from another person or walker (use of cane is acceptable)
- scored 22/30 or higher on the Mini-Mental State Examination (MMSE)
- have no significant functional impairment as indicated by a score of 6/8 or higher on the Lawton and Brody Instrumental Activities of Daily Living Scale
- are able to safely engage in MVPA as indicated by the PAR-Q+ and by the family or study physician as necessary
- are community-dwelling
- are able to provide written informed consent.
Exclusion Criteria:
- are diagnosed with dementia or stroke
- self-report engaging in MVPA ≥ 10 minutes per week in the prior 3 months
- are unable to understand, speak, and read English proficiently
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health Coaching (HC)
The health coaching program will be delivered by trained and certified kinesiologists utilizing Brief Action Planning (BAP) principals.
The BAP behavior change approach utilizes the following 4 techniques: 1) goal-setting; 2 )action planning; 3) self-monitoring; and 4) feedback.
Participants will utilize daily physical activity diaries to enable self-monitoring, and BAP coaches will provide feedback on progress toward individualized physical activity goals.
|
The HC program will be delivered over 26-weeks. Participants will have an initial hour-long HC session where the BAP coach will conduct a brief physical assessment and work with the participant to establish their physical activity goals and develop a plan. After the initial consult, coaches will conduct 8 x 20-minute phone calls with participants over the 26-week trial decreasing from bi-weekly phone calls in weeks 1-12 to monthly phone calls in weeks 13-26. Participants in the HC group will have an overall goal of increasing their weekly participation in moderate to vigorous physical activity by 50 minutes, via 5-, 7-, or 10-minute bouts of progressive exercises, at a rate of perceived exertion range of 13-14 ("somewhat hard") by week 16. Participants will have access to specific exercise sessions made available by YouTube and/or hardcopy manuals created by the research team.
Other Names:
|
|
Active Comparator: Health Education Program (ED)
This program is an attention control group, which consists of general health education.
Education sessions will be delivered either by zoom or in person.
The education sessions will cover the following topics: 1) falls prevention; 2) sleep; 3) healthy eating; 4) cognitive health; and 5) mental and emotional health.
|
Participants will begin with a one-hour, group-based, interactive education session on falls prevention delivered either in-person or by Zoom.
Following the initial education session, ED participants will receive additional group education sessions (in-person or by Zoom) with the same duration and schedule as the HC program covering a variety of healthy aging topics.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility
Time Frame: Baseline, 13-weeks, 26-weeks, 52-weeks
|
Measured by the Short Physical Performance Battery (SPPB)
|
Baseline, 13-weeks, 26-weeks, 52-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Capacity to complete the 400-m walk in ≤ 15 minutes
Time Frame: Baseline, 13- weeks, 26-weeks, 52-weeks
|
measured as yes or no
|
Baseline, 13- weeks, 26-weeks, 52-weeks
|
|
Cognitive function
Time Frame: Baseline, 26-weeks, 52-weeks
|
Measured with the NIH Toolbox and standard neuropsychological assessments
|
Baseline, 26-weeks, 52-weeks
|
|
Community mobility
Time Frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
Measured with the Life Space Questionnaire
|
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
|
Lower extremity strength
Time Frame: Baseline, 13- weeks, 26-weeks, 52-weeks
|
Measured with strain gauge (kilograms) on dominant quadriceps
|
Baseline, 13- weeks, 26-weeks, 52-weeks
|
|
Grip strength
Time Frame: Baseline, 13-weeks, 26-weeks, 52-weeks
|
Measured with digital Jamar isometric dynamometer (Newtons)
|
Baseline, 13-weeks, 26-weeks, 52-weeks
|
|
Mood
Time Frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
Measured by the Centre for Epidemiological Studies Depression Scale (CES-D)
|
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
|
Sleep
Time Frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
Measured with 19-item Pittsburgh Sleep Quality Index
|
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
|
Sleep
Time Frame: Baseline, 13-weeks, 26-weeks, 52-weeks
|
Measured by accelerometer
|
Baseline, 13-weeks, 26-weeks, 52-weeks
|
|
Falls
Time Frame: Baseline, monthly
|
Assessed with monthly calendar and questionnaire
|
Baseline, monthly
|
|
Health resource utilization
Time Frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
Assessed with a questionnaire
|
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
|
Fatigue
Time Frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
Measured by the 9-item Fatigue Severity Scale (FSS) scored from 9 to 63, with higher scores indicating more severe fatigue
|
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
|
Physical activity
Time Frame: Baseline, 13-weeks, 26-weeks, 52-weeks
|
Time spent moderate to vigorous physical activity and sedentary time measured by accelerometer.
|
Baseline, 13-weeks, 26-weeks, 52-weeks
|
|
Self reported physical activity
Time Frame: Baseline, 13-weeks, 26-weeks, 52-weeks
|
Measured by the Community Health Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults.
|
Baseline, 13-weeks, 26-weeks, 52-weeks
|
|
Gait speed
Time Frame: Baseline, 13- weeks, 26-weeks, 52-weeks
|
Measured during the 4-m walk
|
Baseline, 13- weeks, 26-weeks, 52-weeks
|
|
Functional mobility
Time Frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
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Measured as the time to complete the Timed Up-and-Go (TUG)
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Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
|
Health-related quality of life
Time Frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
Measured with questionnaire EuroQol (EQ-5D-5L)
|
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Teresa Liu-Ambrose, PhD, University of British Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H21-00858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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