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

Older Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978336
• Other study ID #: H21-00858
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: December 30, 2027

Study information

• Verified date: October 2023
• Source: University of British Columbia
• Contact: Nathan Wei, B.Sc.
• Phone: 604-875-4111
• Email: nathan.wei[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: December 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Limitation, Mobility
• Mobility Limitation
• Older Adults

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Vancouver Coastal Health Research Institute Research Pavilion	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility	Measured by the Short Physical Performance Battery (SPPB)	Baseline, 13-weeks, 26-weeks, 52-weeks
Secondary	Physical activity	Time spent moderate to vigorous physical activity and sedentary time measured by accelerometer.	Baseline, 13-weeks, 26-weeks, 52-weeks
Secondary	Self reported physical activity	Measured by the Community Health Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults.	Baseline, 13-weeks, 26-weeks, 52-weeks
Secondary	Gait speed	Measured during the 4-m walk	Baseline, 13- weeks, 26-weeks, 52-weeks
Secondary	Capacity to complete the 400-m walk in = 15 minutes	measured as yes or no	Baseline, 13- weeks, 26-weeks, 52-weeks
Secondary	Cognitive function	Measured with the NIH Toolbox and standard neuropsychological assessments	Baseline, 26-weeks, 52-weeks
Secondary	Community mobility	Measured with the Life Space Questionnaire	Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Secondary	Functional mobility	Measured as the time to complete the Timed Up-and-Go (TUG)	Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Secondary	Fatigue	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
Secondary	Lower extremity strength	Measured with strain gauge (kilograms) on dominant quadriceps	Baseline, 13- weeks, 26-weeks, 52-weeks
Secondary	Grip strength	Measured with digital Jamar isometric dynamometer (Newtons)	Baseline, 13-weeks, 26-weeks, 52-weeks
Secondary	Mood	Measured by the Centre for Epidemiological Studies Depression Scale (CES-D)	Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Secondary	Health-related quality of life	Measured with questionnaire EuroQol (EQ-5D-5L)	Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Secondary	Sleep	Measured with 19-item Pittsburgh Sleep Quality Index	Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Secondary	Sleep	Measured by accelerometer	Baseline, 13-weeks, 26-weeks, 52-weeks
Secondary	Falls	Assessed with monthly calendar and questionnaire	Baseline, monthly
Secondary	Health resource utilization	Assessed with a questionnaire	Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks