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

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 Overview

• Status: Recruiting
• Conditions: Mobility Limitation
• Intervention / Treatment: Other: Stepping-Up; Other: Telephone-Based Coaching Walking Program; Other: Chair-Based Yoga Program

• Study Type: Interventional
• Enrollment (Anticipated): 249
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Sinclair, BHScPT; Phone Number: 27810 905-525-9140; Email: ssincla@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1C7
      • Recruiting
      • McMaster University
      • Contact: Susanne Sinclair; Email: ssincla@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Stepping-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.
Active Comparator: TELE Group; The initial telephone session will be 20-30 minutes, with subsequent weekly calls will be approximately 10 minutes.	Other: Telephone-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.
Placebo Comparator: 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.	Other: Chair-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	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.	Baseline
Change in walking speed from 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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in walking speed from 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.	24 weeks
Change in walking speed from 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.	36 weeks
Exercise capacity	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.	Baseline
Change in exercise capacity from 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.	12 weeks
Change in exercise capacity from 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.	24 weeks
Change in exercise capacity from 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.	36 weeks
Lower body strength	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.	Baseline
Change in lower body strength from 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.	12 weeks
Change in lower body strength from 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.	24 weeks
Change in lower body strength from 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.	36 weeks
Dual task cost	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.	Baseline
Change in dual task cost from baseline	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.	12 weeks
Change in dual task cost from baseline	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.	24 weeks
Change in dual task cost from baseline	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.	36 weeks
Self-reported change in mobility	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.	12 weeks
Change in self-reported change in mobility from basseline	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.	24 weeks
Change in self-reported change in mobility from basseline	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.	36 weeks
Balance self-efficacy	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).	Baseline
Change in balance self-efficacy from 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).	12 weeks
Change in balance self-efficacy from 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).	24 weeks
Change in balance self-efficacy from 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).	36 weeks
Mobility patterns	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.	Baseline
Change in mobility patterns from 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.	12 weeks
Change in mobility patterns from 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.	24 weeks
Change in mobility patterns from 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.	36 weeks
Knowledge, skill and confidence for self-management	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).	12 weeks
Change in knowledge, skill and confidence for self-management from baseline	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).	Baseline
Change in knowledge, skill and confidence for self-management from baseline	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).	24 weeks
Change in knowledge, skill and confidence for self-management from baseline	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).	36 weeks
Balance	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.	Baseline
Change in balance from 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.	12 weeks
Change in balance from 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.	24 weeks
Change in balance from 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.	36 weeks
Health-related quality of life	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).	Baseline
Change in health-related quality of life from 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).	12 weeks
Change in health-related quality of life from 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).	24 weeks
Change in health-related quality of life from 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).	36 weeks
Self-efficacy for physical activity:	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.	Baseline
Change in self-efficacy for physical activity from 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.	12 weeks
Change in self-efficacy for physical activity from 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.	24 weeks
Change in self-efficacy for physical activity from 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.	36 weeks
Self-reported mobility	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.	Baseline
Change in self-reported mobility from 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.	12 weeks
Change in self-reported mobility from 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.	24 weeks
Change in self-reported mobility from 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.	36 weeks
Emergency room visits	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Emergency room visits	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Emergency room visits	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks
Hospitalizations	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Hospitalizations	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Hospitalizations	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks
Family doctor visits	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Family doctor visits	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Family doctor visits	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks
Specialist physician visits visits	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Specialist physician visits visits	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Specialist physician visits visits	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks
Medical tests or procedures	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Medical tests or procedures	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Medical tests or procedures	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: YMCA Hamilton/Burlington/Brantford; City of Hamilton
• Investigators: Principal Investigator: Julie Richardson, PhD, McMaster University; Principal Investigator: Ayse Kuspinar, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Self-management; Physical function; Walking ability; Preclinical mobility limitation; Task-oriented motor learning
• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: PJT-169034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No