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Clinical Trials/NCT04368949
NCT04368949
Active, not recruiting
Not Applicable

Stepping-Up: Partnering with the Community to Prevent Early Mobility Decline

McMaster University1 site in 1 country249 target enrollmentStarted: April 1, 2021Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
249
Locations
1
Primary Endpoint
Change in walking speed from baseline

Overview

Brief Summary

Preclinical mobility limitations (PCML) manifest early in the process of declining mobility, and are not typically identified or acted upon by clinicians. These mobility limitations manifest as changes in how daily tasks such as walking are performed (slower speed, lower endurance). Persons in the PCML stage are at increased risk for the onset of disability and chronic disease. Persistent deterioration in mobility is a predictor of mortality and has been reported even in the absence of changes in activities of daily living over a two-year period. Further, older persons with mobility limitations, including reduced gait speed, are at risk for falls. These cumulative transitions of a person's life-long mobility form their mobility trajectory and preventing mobility decline at an early stage along this trajectory is the focus of this research initiative. This study will evaluate a novel intervention, STEPPING-UP, for improving walking ability in persons with PCML.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
55 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Community-dwelling
  • Age ≥55-75 years
  • PCML as assessed using a questionnaire that requires respondents to self-report difficulties with their mobility (walking 2.0km). Respondents will be considered in a stage of PCML if they report no task difficulty but report modification of task performance (i.e. modify frequency, method or time to complete the task)
  • Understanding of spoken and written English
  • Own a laptop computer, have an email address and have internet capabilities of running the video-conferencing platform, Zoom©.
  • Resident of Ontario, Canada

Exclusion Criteria

  • A score of \<11 on the MoCA 5-Minute telephone screen
  • Major illness that would prevent participation

Outcomes

Primary Outcomes

Change in walking speed from baseline

Time Frame: 12 weeks

The 4-Metre Gait Speed Test (4MGS) is a performance-based measure of walking speed. The 4MGS test will be performed from a standing start at both a self-selected (usual) and fastest walking speed.

Walking speed

Time Frame: Baseline

The 4-Metre Gait Speed Test (4MGS) is a performance-based measure of walking speed. The 4MGS test will be performed from a standing start at both a self-selected (usual) and fastest walking speed.

Secondary Outcomes

  • Change in walking speed from baseline(36 weeks)
  • Change in exercise capacity from baseline(36 weeks)
  • Change in mobility patterns from baseline(36 weeks)
  • Change in balance self-efficacy from baseline(36 weeks)
  • Change in knowledge, skill and confidence for self-management from baseline(36 weeks)
  • Balance(Baseline)
  • Hospitalizations(24 weeks to 36 weeks)
  • Exercise capacity(Baseline)
  • Lower body strength(Baseline)
  • Change in lower body strength from baseline(36 weeks)
  • Dual task cost(Baseline)
  • Balance self-efficacy(Baseline)
  • Self-reported mobility(Baseline)
  • Emergency room visits(24 weeks to 36 weeks)
  • Change in dual task cost from baseline(36 weeks)
  • Self-reported change in mobility(12 weeks)
  • Change in self-reported change in mobility from basseline(36 weeks)
  • Knowledge, skill and confidence for self-management(12 weeks)
  • Change in balance from baseline(36 weeks)
  • Change in health-related quality of life from baseline(36 weeks)
  • Change in self-efficacy for physical activity from baseline(36 weeks)
  • Change in self-reported mobility from baseline(36 weeks)
  • Family doctor visits(24 weeks to 36 weeks)
  • Specialist physician visits visits(24 weeks to 36 weeks)
  • Mobility patterns(Baseline)
  • Health-related quality of life(Baseline)
  • Self-efficacy for physical activity:(Baseline)
  • Medical tests or procedures(24 weeks to 36 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Julie Richardson

Principal Investigator

McMaster University

Study Sites (1)

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