SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults

• Sponsor: University of British Columbia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05978336
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 290
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 53
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

The goal of this randomized controlled trial is to investigate the effectiveness of a health-coaching intervention to improve physical activity in older adults with limited mobility when compared to a control, health education group.

Condition or Disease	Intervention/Treatment	Phase
Limitation, Mobility; Older Adults	Behavioral: Health Coaching Program; Behavioral: Health Education Program	N/A

Detailed Description

A total of 290 older adults with limited mobility will be randomized to either a 26-week health coaching program or health education program. Outcomes will be assessed at baseline, 13-weeks, 26-weeks (end of intervention), and 52 week (6-month follow-up period).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults
• Anticipated Study Start Date: Jul 31, 2023
• Anticipated Primary Completion Date: Jun 30, 2027
• Anticipated Study Completion Date: Dec 30, 2027

Arms and Interventions

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.	Behavioral: Health Coaching Program; 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: HC
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.	Behavioral: Health Education Program; 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: ED

Outcome Measures

Primary Outcome Measures

1. Mobility [Baseline, 13-weeks, 26-weeks, 52-weeks]

   Measured by the Short Physical Performance Battery (SPPB)

2. Time in moderate to vigorous physical activity [Baseline, 13-weeks, 26-weeks, 52-weeks]

   Time spent in moderate to vigorous physical activity (MVPA) measured by accelerometer

Secondary Outcome Measures

1. Sedentary Time [Baseline, 13-weeks, 26-weeks, 52-weeks]

   Time spent sedentary measured by accelerometer

2. Gait speed [Baseline, 13- weeks, 26-weeks, 52-weeks]

   Measured during the 400-m walk

3. Capacity to complete the 400-m walk in ≤ 15 minutes [Baseline, 13- weeks, 26-weeks, 52-weeks]

   measured as yes or no

4. Cognitive function [Baseline, 26-weeks, 52-weeks]

   Measured with the NIH Toolbox and standard neuropsychological assessments

5. Community mobility [Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]

   Measured with the Life Space Questionnaire

6. Physical mobility [Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]

   Measured as the time to complete the Timed Up-and-Go (TUG)

7. Fatigue [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

8. Lower extremity strength [Baseline, 13- weeks, 26-weeks, 52-weeks]

   Measured with strain gauge (kilograms) on dominant quadriceps

9. Grip strength [Baseline, 13-weeks, 26-weeks, 52-weeks]

   Measured with digital Jamar isometric dynamometer (Newtons)

10. Mood [Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]

    Measured by the Centre for Epidemiological Studies Depression Scale (CES-D)

11. Self Reported Quality of Life [Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]

    Measured with questionnaire EuroQol (EQ-5D-5L)

12. Sleep [Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]

    Measured with 19-item Pittsburgh Sleep Quality Index

13. Sleep [Baseline, 13-weeks, 26-weeks, 52-weeks]

    Measured by accelerometer

14. Falls [Baseline, monthly]

    Assessed with monthly calendar and questionnaire

15. Health resource utilization [Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]

    Assessed with a questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 on the Mini-Mental State Examination (MMSE)

• have no significant functional impairment and no dementia

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vancouver Coastal Health Research Institute Research Pavilion	Vancouver	British Columbia	Canada	V5Z 1L8

Sponsors and Collaborators

• University of British Columbia
• Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Teresa Liu-Ambrose, PhD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teresa Liu-Ambrose, Professor, University of British Columbia
• ClinicalTrials.gov Identifier: NCT05978336
• Other Study ID Numbers: H21-00858
• First Posted: Aug 7, 2023
• Last Update Posted: Aug 8, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Teresa Liu-Ambrose, Professor, University of British Columbia: physical activity; health coaching; exercise; limited mobility
• Additional relevant MeSH terms: Mobility Limitation

Study Results

No Results Posted as of Aug 8, 2023