Clinical trial NCT04368949: Stepping-Up: Partnering with the Community to Prevent Early Mobility Decline
Official title: Stepping-Up: Partnering with the Community to Prevent Early Mobility Decline
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mobility Limitation
Keywords: Preclinical mobility limitation
Walking ability
Physical function
Task-oriented motor learning
Self-management
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: YMCA Hamilton/Burlington/Brantford
name: City of Hamilton
First posted: 2020-04-30
Enrollment: 249
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Community-dwelling
2. Age ≥55-75 years
3. 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)
4. Understanding of spoken and written English
5. Own a laptop computer, have an email address and have internet capabilities of running the video-conferencing platform, Zoom©.
6. Resident of Ontario, Canada

Exclusion Criteria:

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

Primary outcomes:
measure: Walking speed
timeFrame: Baseline
measure: Change in walking speed from baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in walking speed from baseline
timeFrame: 24 weeks
measure: Change in walking speed from baseline
timeFrame: 36 weeks
measure: Exercise capacity
timeFrame: Baseline
measure: Change in exercise capacity from baseline
timeFrame: 12 weeks
measure: Change in exercise capacity from baseline
timeFrame: 24 weeks
measure: Change in exercise capacity from baseline
timeFrame: 36 weeks
measure: Lower body strength
timeFrame: Baseline
measure: Change in lower body strength from baseline
timeFrame: 12 weeks
measure: Change in lower body strength from baseline
timeFrame: 24 weeks
measure: Change in lower body strength from baseline
timeFrame: 36 weeks
measure: Dual task cost
timeFrame: Baseline
measure: Change in dual task cost from baseline
timeFrame: 12 weeks
measure: Change in dual task cost from baseline
timeFrame: 24 weeks
measure: Change in dual task cost from baseline
timeFrame: 36 weeks
measure: Self-reported change in mobility
timeFrame: 12 weeks
measure: Change in self-reported change in mobility from basseline
timeFrame: 24 weeks
measure: Change in self-reported change in mobility from basseline
timeFrame: 36 weeks
measure: Balance self-efficacy
timeFrame: Baseline
measure: Change in balance self-efficacy from baseline
timeFrame: 12 weeks
measure: Change in balance self-efficacy from baseline
timeFrame: 24 weeks
measure: Change in balance self-efficacy from baseline
timeFrame: 36 weeks
measure: Mobility patterns
timeFrame: Baseline
measure: Change in mobility patterns from baseline
timeFrame: 12 weeks
measure: Change in mobility patterns from baseline
timeFrame: 24 weeks
measure: Change in mobility patterns from baseline
timeFrame: 36 weeks
measure: Knowledge, skill and confidence for self-management
timeFrame: 12 weeks
measure: Change in knowledge, skill and confidence for self-management from baseline
timeFrame: Baseline
measure: Change in knowledge, skill and confidence for self-management from baseline
timeFrame: 24 weeks
measure: Change in knowledge, skill and confidence for self-management from baseline
timeFrame: 36 weeks
measure: Balance
timeFrame: Baseline
measure: Change in balance from baseline
timeFrame: 12 weeks
measure: Change in balance from baseline
timeFrame: 24 weeks
measure: Change in balance from baseline
timeFrame: 36 weeks
measure: Health-related quality of life
timeFrame: Baseline
measure: Change in health-related quality of life from baseline
timeFrame: 12 weeks
measure: Change in health-related quality of life from baseline
timeFrame: 24 weeks
measure: Change in health-related quality of life from baseline
timeFrame: 36 weeks
measure: Self-efficacy for physical activity:
timeFrame: Baseline
measure: Change in self-efficacy for physical activity from baseline
timeFrame: 12 weeks
measure: Change in self-efficacy for physical activity from baseline
timeFrame: 24 weeks
measure: Change in self-efficacy for physical activity from baseline
timeFrame: 36 weeks
measure: Self-reported mobility
timeFrame: Baseline
measure: Change in self-reported mobility from baseline
timeFrame: 12 weeks
measure: Change in self-reported mobility from baseline
timeFrame: 24 weeks
measure: Change in self-reported mobility from baseline
timeFrame: 36 weeks
measure: Emergency room visits
timeFrame: Baseline to 12 weeks
measure: Emergency room visits
timeFrame: 12 weeks to 24 weeks
measure: Emergency room visits
timeFrame: 24 weeks to 36 weeks
measure: Hospitalizations
timeFrame: Baseline to 12 weeks
measure: Hospitalizations
timeFrame: 12 weeks to 24 weeks
measure: Hospitalizations
timeFrame: 24 weeks to 36 weeks
measure: Family doctor visits
timeFrame: Baseline to 12 weeks
measure: Family doctor visits
timeFrame: 12 weeks to 24 weeks
measure: Family doctor visits
timeFrame: 24 weeks to 36 weeks
measure: Specialist physician visits visits
timeFrame: Baseline to 12 weeks
measure: Specialist physician visits visits
timeFrame: 12 weeks to 24 weeks
measure: Specialist physician visits visits
timeFrame: 24 weeks to 36 weeks
measure: Medical tests or procedures
timeFrame: Baseline to 12 weeks
measure: Medical tests or procedures
timeFrame: 12 weeks to 24 weeks
measure: Medical tests or procedures
timeFrame: 24 weeks to 36 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Julie Richardson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Ayse Kuspinar, PhD
role: PRINCIPAL_INVESTIGATOR
References: