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

Not Applicable

Active, not recruiting

• Conditions: Mobility Limitation
• Interventions: Other: Telephone-Based Coaching Walking Program; Other: Chair-Based Yoga Program; Other: Stepping-Up

• Registration Number: NCT04368949
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Study Start: 2021-04-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-09
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 249

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TELE Group	Telephone-Based Coaching Walking Program	The initial telephone session will be 20-30 minutes, with subsequent weekly calls will be approximately 10 minutes.
Chair-Based Yoga Group	Chair-Based Yoga Program	Participants will attend two 1-hour virtual sessions per week to ensure this group is matched for attention to STEPPING-UP.
Stepping-Up Group	Stepping-Up	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.

Primary Outcome Measures

Name	Time	Method
Change in walking speed from baseline	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	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 Outcome Measures

Name	Time	Method
Change in balance self-efficacy from baseline	36 weeks	Activities-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 walking speed from baseline	36 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.
Change in exercise capacity from baseline	36 weeks	2-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 mobility patterns from baseline	36 weeks	The 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 knowledge, skill and confidence for self-management from baseline	36 weeks	Patient 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).
Balance	Baseline	Unipedal 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.
Hospitalizations	24 weeks to 36 weeks	Healthcare utilization data collected using self-report self-report.
Exercise capacity	Baseline	2-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 strength	Baseline	30-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 baseline	36 weeks	30-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 cost	Baseline	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Balance self-efficacy	Baseline	Activities-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).
Self-reported mobility	Baseline	Mobility 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 visits	24 weeks to 36 weeks	Healthcare utilization data collected using self-report self-report.
Change in dual task cost from baseline	36 weeks	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Self-reported change in mobility	12 weeks	Global 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 basseline	36 weeks	Global 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.
Knowledge, skill and confidence for self-management	12 weeks	Patient 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 balance from baseline	36 weeks	Unipedal 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 health-related quality of life from baseline	36 weeks	EQ-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 self-efficacy for physical activity from baseline	36 weeks	Participants 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-reported mobility from baseline	36 weeks	Mobility 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.
Family doctor visits	24 weeks to 36 weeks	Healthcare utilization data collected using self-report self-report.
Specialist physician visits visits	24 weeks to 36 weeks	Healthcare utilization data collected using self-report self-report.
Mobility patterns	Baseline	The 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.
Health-related quality of life	Baseline	EQ-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:	Baseline	Participants 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.
Medical tests or procedures	24 weeks to 36 weeks	Healthcare utilization data collected using self-report self-report.

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada