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Recruiting NCT05978336

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

No phase Interventional Limitation, Mobility Older Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health Coaching Program, Health Education Program.
Who it may be relevant to
Registry conditions: Limitation, Mobility, Older Adults. Basic parameters: 70 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • 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 ha
  • 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.

Primary outcome measures

  • Mobility [Time frame: Baseline, 13-weeks, 26-weeks, 52-weeks]
Secondary outcome measures (12)
  • Physical activity [Time frame: Baseline, 13-weeks, 26-weeks, 52-weeks]
  • Self reported physical activity [Time frame: Baseline, 13-weeks, 26-weeks, 52-weeks]
  • Gait speed [Time frame: Baseline, 13- weeks, 26-weeks, 52-weeks]
  • Capacity to complete the 400-m walk in ≤ 15 minutes [Time frame: Baseline, 13- weeks, 26-weeks, 52-weeks]
  • Cognitive function [Time frame: Baseline, 26-weeks, 52-weeks]
  • Community mobility [Time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]
  • Functional mobility [Time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]
  • Fatigue [Time frame: Baseline, 13-weeks, 26-weeks, 39-weeks, 52-weeks]
  • Lower extremity strength [Time frame: Baseline, 13- weeks, 26-weeks, 52-weeks]
  • Grip strength [Time frame: Baseline, 13-weeks, 26-weeks, 52-weeks]
  • Mood [Time frame: 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Vancouver Coastal Health Research Institute Research Pavilion — Vancouver

Publications

  • Rice J, Li LC, Davis JC, Pahor M, Madden K, Wei N, Wong H, Skelton DA, McCormick S, Falck RS, Barha CK, Rhodes RE, Loomba S, Sadatsafavi M, Liu-Ambrose T. Supporting physical activity for mobility in older adults with mobility limitations (SuPA Mobility): study protocol for a randomized controlled trial. Trials. 2023 Nov 28;24(1):769. doi: 10.1186/s13063-023-07798-9. PMID 38017467

Identifiers

NCT: NCT05978336 · H21-00858

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗