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

Primary Purpose

Limitation, Mobility, Older Adults

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Health Coaching Program
Health Education Program
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Limitation, Mobility focused on measuring physical activity, health coaching, exercise, limited mobility

Eligibility Criteria

70 Years - 89 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver Coastal Health Research Institute Research PavilionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Health Coaching (HC)

Health Education Program (ED)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mobility
Measured by the Short Physical Performance Battery (SPPB)

Secondary Outcome Measures

Physical activity
Time spent moderate to vigorous physical activity and sedentary time measured by accelerometer.
Self reported physical activity
Measured by the Community Health Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults.
Gait speed
Measured during the 4-m walk
Capacity to complete the 400-m walk in ≤ 15 minutes
measured as yes or no
Cognitive function
Measured with the NIH Toolbox and standard neuropsychological assessments
Community mobility
Measured with the Life Space Questionnaire
Functional mobility
Measured as the time to complete the Timed Up-and-Go (TUG)
Fatigue
Measured by the 9-item Fatigue Severity Scale (FSS) scored from 9 to 63, with higher scores indicating more severe fatigue
Lower extremity strength
Measured with strain gauge (kilograms) on dominant quadriceps
Grip strength
Measured with digital Jamar isometric dynamometer (Newtons)
Mood
Measured by the Centre for Epidemiological Studies Depression Scale (CES-D)
Health-related quality of life
Measured with questionnaire EuroQol (EQ-5D-5L)
Sleep
Measured with 19-item Pittsburgh Sleep Quality Index
Sleep
Measured by accelerometer
Falls
Assessed with monthly calendar and questionnaire
Health resource utilization
Assessed with a questionnaire

Full Information

First Posted
July 28, 2023
Last Updated
October 19, 2023
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05978336
Brief Title
SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults
Official Title
SuPA Mobility: Supporting Physical Activity for Mobility in Mobility-Limited Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
December 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limitation, Mobility, Older Adults
Keywords
physical activity, health coaching, exercise, limited mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Coaching (HC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education Program (ED)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Coaching Program
Other Intervention Name(s)
HC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education Program
Other Intervention Name(s)
ED
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mobility
Description
Measured by the Short Physical Performance Battery (SPPB)
Time Frame
Baseline, 13-weeks, 26-weeks, 52-weeks
Secondary Outcome Measure Information:
Title
Physical activity
Description
Time spent moderate to vigorous physical activity and sedentary time measured by accelerometer.
Time Frame
Baseline, 13-weeks, 26-weeks, 52-weeks
Title
Self reported physical activity
Description
Measured by the Community Health Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults.
Time Frame
Baseline, 13-weeks, 26-weeks, 52-weeks
Title
Gait speed
Description
Measured during the 4-m walk
Time Frame
Baseline, 13- weeks, 26-weeks, 52-weeks
Title
Capacity to complete the 400-m walk in ≤ 15 minutes
Description
measured as yes or no
Time Frame
Baseline, 13- weeks, 26-weeks, 52-weeks
Title
Cognitive function
Description
Measured with the NIH Toolbox and standard neuropsychological assessments
Time Frame
Baseline, 26-weeks, 52-weeks
Title
Community mobility
Description
Measured with the Life Space Questionnaire
Time Frame
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Title
Functional mobility
Description
Measured as the time to complete the Timed Up-and-Go (TUG)
Time Frame
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Title
Fatigue
Description
Measured by the 9-item Fatigue Severity Scale (FSS) scored from 9 to 63, with higher scores indicating more severe fatigue
Time Frame
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Title
Lower extremity strength
Description
Measured with strain gauge (kilograms) on dominant quadriceps
Time Frame
Baseline, 13- weeks, 26-weeks, 52-weeks
Title
Grip strength
Description
Measured with digital Jamar isometric dynamometer (Newtons)
Time Frame
Baseline, 13-weeks, 26-weeks, 52-weeks
Title
Mood
Description
Measured by the Centre for Epidemiological Studies Depression Scale (CES-D)
Time Frame
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Title
Health-related quality of life
Description
Measured with questionnaire EuroQol (EQ-5D-5L)
Time Frame
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Title
Sleep
Description
Measured with 19-item Pittsburgh Sleep Quality Index
Time Frame
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks
Title
Sleep
Description
Measured by accelerometer
Time Frame
Baseline, 13-weeks, 26-weeks, 52-weeks
Title
Falls
Description
Assessed with monthly calendar and questionnaire
Time Frame
Baseline, monthly
Title
Health resource utilization
Description
Assessed with a questionnaire
Time Frame
Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Wei, B.Sc.
Phone
604-875-4111
Ext
69056
Email
nathan.wei@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Liu-Ambrose, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver Coastal Health Research Institute Research Pavilion
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Wei, B.SC
Phone
604-875-4111
Ext
69056
Email
cogmob.research@hiphealth.ca
First Name & Middle Initial & Last Name & Degree
Teresa Liu-Ambrose, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

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

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