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

Primary Purpose

Mobility Limitation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stepping-Up
Telephone-Based Coaching Walking Program
Chair-Based Yoga Program
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mobility Limitation focused on measuring Preclinical mobility limitation, Walking ability, Physical function, Task-oriented motor learning, Self-management

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Stepping-Up Group

TELE Group

Chair-Based Yoga Group

Arm Description

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.

The initial telephone session will be 20-30 minutes, with subsequent weekly calls will be approximately 10 minutes.

Participants will attend two 1-hour virtual sessions per week to ensure this group is matched for attention to STEPPING-UP.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Dual task cost
Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Change in dual task cost from baseline
Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Change in dual task cost from baseline
Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Change in dual task cost from baseline
Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Emergency room visits
Healthcare utilization data collected using self-report self-report.
Emergency room visits
Healthcare utilization data collected using self-report self-report.
Emergency room visits
Healthcare utilization data collected using self-report self-report.
Hospitalizations
Healthcare utilization data collected using self-report self-report.
Hospitalizations
Healthcare utilization data collected using self-report self-report.
Hospitalizations
Healthcare utilization data collected using self-report self-report.
Family doctor visits
Healthcare utilization data collected using self-report self-report.
Family doctor visits
Healthcare utilization data collected using self-report self-report.
Family doctor visits
Healthcare utilization data collected using self-report self-report.
Specialist physician visits visits
Healthcare utilization data collected using self-report self-report.
Specialist physician visits visits
Healthcare utilization data collected using self-report self-report.
Specialist physician visits visits
Healthcare utilization data collected using self-report self-report.
Medical tests or procedures
Healthcare utilization data collected using self-report self-report.
Medical tests or procedures
Healthcare utilization data collected using self-report self-report.
Medical tests or procedures
Healthcare utilization data collected using self-report self-report.

Full Information

First Posted
April 23, 2020
Last Updated
May 9, 2023
Sponsor
McMaster University
Collaborators
YMCA Hamilton/Burlington/Brantford, City of Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT04368949
Brief Title
Stepping-Up: Partnering With the Community to Prevent Early Mobility Decline
Acronym
Stepping-Up
Official Title
Stepping-Up: Partnering With the Community to Prevent Early Mobility Decline
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
YMCA Hamilton/Burlington/Brantford, City of Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
Keywords
Preclinical mobility limitation, Walking ability, Physical function, Task-oriented motor learning, Self-management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
249 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stepping-Up Group
Arm Type
Experimental
Arm Description
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.
Arm Title
TELE Group
Arm Type
Active Comparator
Arm Description
The initial telephone session will be 20-30 minutes, with subsequent weekly calls will be approximately 10 minutes.
Arm Title
Chair-Based Yoga Group
Arm Type
Placebo Comparator
Arm Description
Participants will attend two 1-hour virtual sessions per week to ensure this group is matched for attention to STEPPING-UP.
Intervention Type
Other
Intervention Name(s)
Stepping-Up
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Telephone-Based Coaching Walking Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Chair-Based Yoga Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Walking speed
Description
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.
Time Frame
Baseline
Title
Change in walking speed from baseline
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in walking speed from baseline
Description
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.
Time Frame
24 weeks
Title
Change in walking speed from baseline
Description
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.
Time Frame
36 weeks
Title
Exercise capacity
Description
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.
Time Frame
Baseline
Title
Change in exercise capacity from baseline
Description
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.
Time Frame
12 weeks
Title
Change in exercise capacity from baseline
Description
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.
Time Frame
24 weeks
Title
Change in exercise capacity from baseline
Description
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.
Time Frame
36 weeks
Title
Lower body strength
Description
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.
Time Frame
Baseline
Title
Change in lower body strength from baseline
Description
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.
Time Frame
12 weeks
Title
Change in lower body strength from baseline
Description
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.
Time Frame
24 weeks
Title
Change in lower body strength from baseline
Description
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.
Time Frame
36 weeks
Title
Dual task cost
Description
Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Time Frame
Baseline
Title
Change in dual task cost from baseline
Description
Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Time Frame
12 weeks
Title
Change in dual task cost from baseline
Description
Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Time Frame
24 weeks
Title
Change in dual task cost from baseline
Description
Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.
Time Frame
36 weeks
Title
Self-reported change in mobility
Description
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.
Time Frame
12 weeks
Title
Change in self-reported change in mobility from basseline
Description
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.
Time Frame
24 weeks
Title
Change in self-reported change in mobility from basseline
Description
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.
Time Frame
36 weeks
Title
Balance self-efficacy
Description
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).
Time Frame
Baseline
Title
Change in balance self-efficacy from baseline
Description
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).
Time Frame
12 weeks
Title
Change in balance self-efficacy from baseline
Description
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).
Time Frame
24 weeks
Title
Change in balance self-efficacy from baseline
Description
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).
Time Frame
36 weeks
Title
Mobility patterns
Description
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.
Time Frame
Baseline
Title
Change in mobility patterns from baseline
Description
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.
Time Frame
12 weeks
Title
Change in mobility patterns from baseline
Description
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.
Time Frame
24 weeks
Title
Change in mobility patterns from baseline
Description
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.
Time Frame
36 weeks
Title
Knowledge, skill and confidence for self-management
Description
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).
Time Frame
12 weeks
Title
Change in knowledge, skill and confidence for self-management from baseline
Description
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).
Time Frame
Baseline
Title
Change in knowledge, skill and confidence for self-management from baseline
Description
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).
Time Frame
24 weeks
Title
Change in knowledge, skill and confidence for self-management from baseline
Description
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).
Time Frame
36 weeks
Title
Balance
Description
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.
Time Frame
Baseline
Title
Change in balance from baseline
Description
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.
Time Frame
12 weeks
Title
Change in balance from baseline
Description
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.
Time Frame
24 weeks
Title
Change in balance from baseline
Description
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.
Time Frame
36 weeks
Title
Health-related quality of life
Description
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).
Time Frame
Baseline
Title
Change in health-related quality of life from baseline
Description
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).
Time Frame
12 weeks
Title
Change in health-related quality of life from baseline
Description
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).
Time Frame
24 weeks
Title
Change in health-related quality of life from baseline
Description
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).
Time Frame
36 weeks
Title
Self-efficacy for physical activity:
Description
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.
Time Frame
Baseline
Title
Change in self-efficacy for physical activity from baseline
Description
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.
Time Frame
12 weeks
Title
Change in self-efficacy for physical activity from baseline
Description
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.
Time Frame
24 weeks
Title
Change in self-efficacy for physical activity from baseline
Description
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.
Time Frame
36 weeks
Title
Self-reported mobility
Description
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.
Time Frame
Baseline
Title
Change in self-reported mobility from baseline
Description
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.
Time Frame
12 weeks
Title
Change in self-reported mobility from baseline
Description
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.
Time Frame
24 weeks
Title
Change in self-reported mobility from baseline
Description
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.
Time Frame
36 weeks
Title
Emergency room visits
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
Baseline to 12 weeks
Title
Emergency room visits
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
12 weeks to 24 weeks
Title
Emergency room visits
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
24 weeks to 36 weeks
Title
Hospitalizations
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
Baseline to 12 weeks
Title
Hospitalizations
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
12 weeks to 24 weeks
Title
Hospitalizations
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
24 weeks to 36 weeks
Title
Family doctor visits
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
Baseline to 12 weeks
Title
Family doctor visits
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
12 weeks to 24 weeks
Title
Family doctor visits
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
24 weeks to 36 weeks
Title
Specialist physician visits visits
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
Baseline to 12 weeks
Title
Specialist physician visits visits
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
12 weeks to 24 weeks
Title
Specialist physician visits visits
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
24 weeks to 36 weeks
Title
Medical tests or procedures
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
Baseline to 12 weeks
Title
Medical tests or procedures
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
12 weeks to 24 weeks
Title
Medical tests or procedures
Description
Healthcare utilization data collected using self-report self-report.
Time Frame
24 weeks to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Community-dwelling Age ≥55-75 years 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) Understanding of spoken and written English Own a laptop computer, have an email address and have internet capabilities of running the video-conferencing platform, Zoom©. Resident of Ontario, Canada Exclusion Criteria: A score of <11 on the MoCA 5-Minute telephone screen Major illness that would prevent participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Sinclair, BHScPT
Phone
905-525-9140
Ext
27810
Email
ssincla@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Richardson, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayse Kuspinar, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1C7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Sinclair
Email
ssincla@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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