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

Mobility Limitation Clinical Trial

— Stepping-Up  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368949
• Other study ID #: PJT-169034
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: McMaster University
• Contact: Susanne Sinclair, BHScPT
• Phone: 905-525-9140
• Email: ssincla[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 249
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	City of Hamilton, YMCA Hamilton/Burlington/Brantford

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Dual task cost	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.	Baseline
Secondary	Change in dual task cost from baseline	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.	12 weeks
Secondary	Change in dual task cost from baseline	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.	24 weeks
Secondary	Change in dual task cost from baseline	Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.	36 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Emergency room visits	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Secondary	Emergency room visits	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Secondary	Emergency room visits	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks
Secondary	Hospitalizations	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Secondary	Hospitalizations	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Secondary	Hospitalizations	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks
Secondary	Family doctor visits	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Secondary	Family doctor visits	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Secondary	Family doctor visits	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks
Secondary	Specialist physician visits visits	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Secondary	Specialist physician visits visits	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Secondary	Specialist physician visits visits	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks
Secondary	Medical tests or procedures	Healthcare utilization data collected using self-report self-report.	Baseline to 12 weeks
Secondary	Medical tests or procedures	Healthcare utilization data collected using self-report self-report.	12 weeks to 24 weeks
Secondary	Medical tests or procedures	Healthcare utilization data collected using self-report self-report.	24 weeks to 36 weeks