Stepping-Up: Partnering With the Community to Prevent Early Mobility Decline
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- McMaster University
- Enrollment
- 249
- Locations
- 2
- Primary Endpoint
- Change in walking speed from baseline
Study 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
Arms & Interventions
Stepping-Up Group
Participants will attend one 2-hour virtual session (1-hour exercise and 1-hour SM) per week. Each class of 6-8 participants is supervised by a Physiotherapist (PT) and kinesiologist who will individually tailor the exercises for each participant.
Intervention: Stepping-Up (Other)
TELE Group
The initial telephone session will be 20-30 minutes, with subsequent weekly calls will be approximately 10 minutes.
Intervention: Telephone-Based Coaching Walking Program (Other)
Chair-Based Yoga Group
Participants will attend two 1-hour virtual sessions per week to ensure this group is matched for attention to STEPPING-UP.
Intervention: Chair-Based Yoga Program (Other)
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
Julie Richardson
Principal Investigator
McMaster University