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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04368949
Acronym
Stepping-Up
Enrollment
249
Registered
2020-04-30
Start date
2021-04-01
Completion date
2027-03-31
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mobility Limitation

Keywords

Preclinical mobility limitation, Walking ability, Physical function, Task-oriented motor learning, Self-management

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.

Interventions

OTHERTelephone-Based Coaching Walking Program

The participants assigned to this group will receive a 12-week Telephone-Based Coaching Walking Program (TELE) delivered by a PT who will help participants set short and long term walking goals.

OTHERChair-Based Yoga Program

Participants assigned to this group will receive a virtual 12-week Chair-Based Yoga Program (YOGA), a group-based exercise control where participants will undertake a seated exercise program that includes: warm up, seated and standing yoga poses, cool down.

OTHERStepping-Up

The intervention group will receive STEPPING-UP, a virtual 12-week, multicomponent intervention that includes tailored task-oriented motor learning exercise and a mobility self-management (SM) program.

Sponsors

McMaster University
Lead SponsorOTHER
YMCA Hamilton/Burlington/Brantford
CollaboratorUNKNOWN
City of Hamilton
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Walking speedBaselineThe 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.
Change in walking speed from baseline12 weeksThe 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

MeasureTime frameDescription
Change in walking speed from baseline24 weeksThe 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.
Exercise capacityBaseline2-Minute Step Test (TMST): The TMST is a test of exercise capacity that can be used as an alternative to a timed long-distance walking test when assessment space is limited. Individuals are required to march in place as quickly as possible for 2 minutes while lifting their knees to a height midway between their patella and iliac crest when standing.
Change in exercise capacity from baseline12 weeks2-Minute Step Test (TMST): The TMST is a test of exercise capacity that can be used as an alternative to a timed long-distance walking test when assessment space is limited. Individuals are required to march in place as quickly as possible for 2 minutes while lifting their knees to a height midway between their patella and iliac crest when standing.
Lower body strengthBaseline30-Second Chair Stand Test (CST): The 30-Second CST is used to assess lower body strength and power and is measured by the number of chair stand repetitions in a 30-second period.
Change in lower body strength from baseline12 weeks30-Second Chair Stand Test (CST): The 30-Second CST is used to assess lower body strength and power and is measured by the number of chair stand repetitions in a 30-second period.
Dual task costBaselineDifference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Change in dual task cost from baseline12 weeksDifference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Self-reported change in mobility12 weeksGlobal Mobility Change Rating: A single question, ''Since your last visit, has there been any change in your mobility?'' will be asked. The response will be made on a 11-point self-reported Likert scale: - 5 = very much worse; 0 = unchanged; 5 = very much better.
Change in self-reported change in mobility from basseline24 weeksGlobal Mobility Change Rating: A single question, ''Since your last visit, has there been any change in your mobility?'' will be asked. The response will be made on a 11-point self-reported Likert scale: - 5 = very much worse; 0 = unchanged; 5 = very much better.
Balance self-efficacyBaselineActivities-specific Balance Confidence (ABC) Scale: The ABC Scale is a self-report measure of balance confidence. Individuals are asked to rate their confidence in completing 16 common tasks without losing balance, on a scale from 0% (no confidence) to 100% (complete confidence).
Change in balance self-efficacy from baseline12 weeksActivities-specific Balance Confidence (ABC) Scale: The ABC Scale is a self-report measure of balance confidence. Individuals are asked to rate their confidence in completing 16 common tasks without losing balance, on a scale from 0% (no confidence) to 100% (complete confidence).
Mobility patternsBaselineThe Life-Space Assessment (LSA): The LSA measures a person's usual pattern of mobility during a 1-month period, documenting mobility based on how far and how often a person travels and any assistance required.
Change in mobility patterns from baseline12 weeksThe Life-Space Assessment (LSA): The LSA measures a person's usual pattern of mobility during a 1-month period, documenting mobility based on how far and how often a person travels and any assistance required.
Knowledge, skill and confidence for self-management12 weeksPatient Activation Measure (PAM): The PAM is a 13-item measure of the patient's level of knowledge, skill and confidence for SM. An Activation Score is calculated as the sum of the 13 items. The Activation Score can then be converted into an Activation Level (Level 1 = low activation, Level 4 = high activation).
Change in knowledge, skill and confidence for self-management from baselineBaselinePatient Activation Measure (PAM): The PAM is a 13-item measure of the patient's level of knowledge, skill and confidence for SM. An Activation Score is calculated as the sum of the 13 items. The Activation Score can then be converted into an Activation Level (Level 1 = low activation, Level 4 = high activation).
BalanceBaselineUnipedal Stance Test (UPST): The UPST is used to assess static balance. 68 Individuals are asked to stand barefoot on the limb of their choice until they (1) use their arms (i.e., uncross arms), (2) use their raised foot (i.e., move it toward or away from the standing limb or touched the floor), (3) move the weight-bearing foot to maintain their balance (i.e., rotate foot on the ground) or (4) maintain the position for a maximum of 45 seconds.
Change in balance from baseline12 weeksUnipedal Stance Test (UPST): The UPST is used to assess static balance. 68 Individuals are asked to stand barefoot on the limb of their choice until they (1) use their arms (i.e., uncross arms), (2) use their raised foot (i.e., move it toward or away from the standing limb or touched the floor), (3) move the weight-bearing foot to maintain their balance (i.e., rotate foot on the ground) or (4) maintain the position for a maximum of 45 seconds.
Health-related quality of lifeBaselineEQ-5D-5L is a generic utility-based health related quality of life questionnaire. Respondents are asked to rate 5 dimensions of their health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The five response levels are:no problems (1), slight problems (2), moderate problems (3), severe problems (4), unable to /extreme problems (5).
Change in health-related quality of life from baseline12 weeksEQ-5D-5L is a generic utility-based health related quality of life questionnaire. Respondents are asked to rate 5 dimensions of their health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The five response levels are:no problems (1), slight problems (2), moderate problems (3), severe problems (4), unable to /extreme problems (5).
Self-efficacy for physical activity:BaselineParticipants will be asked to rate how confident they are that they could participate in moderate intensity physical activity for 150 minutes per week using a single question on a scale of 1-10. Higher values indicate greater self-efficacy.
Change in self-efficacy for physical activity from baseline12 weeksParticipants will be asked to rate how confident they are that they could participate in moderate intensity physical activity for 150 minutes per week using a single question on a scale of 1-10. Higher values indicate greater self-efficacy.
Self-reported mobilityBaselineMobility Assessment Tool (MAT-sf): The MAT-sf is a video-animated tool for assessing mobility. It consists of 10 animated video clips that assess an individuals' perceived level of proficiency in performing each task.
Change in self-reported mobility from baseline12 weeksMobility Assessment Tool (MAT-sf): The MAT-sf is a video-animated tool for assessing mobility. It consists of 10 animated video clips that assess an individuals' perceived level of proficiency in performing each task.
Emergency room visitsBaseline to 12 weeksHealthcare utilization data collected using self-report self-report.
HospitalizationsBaseline to 12 weeksHealthcare utilization data collected using self-report self-report.
Family doctor visitsBaseline to 12 weeksHealthcare utilization data collected using self-report self-report.
Specialist physician visits visitsBaseline to 12 weeksHealthcare utilization data collected using self-report self-report.
Medical tests or proceduresBaseline to 12 weeksHealthcare utilization data collected using self-report self-report.

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORJulie Richardson, PhD

McMaster University

PRINCIPAL_INVESTIGATORAyse Kuspinar, PhD

McMaster University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026