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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368949
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
YMCA Hamilton/Burlington/Brantford
City of Hamilton
Information provided by (Responsible Party):
Julie Richardson, 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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Other: Stepping-Up Other: Telephone-Based Coaching Walking Program Other: Chair-Based Stretching and Strengthening Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Stepping-Up: Partnering With the Community to Prevent Early Mobility Decline
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Arm Intervention/treatment
Experimental: Stepping-Up Group
Participants will attend one 2-hour session (1-hour exercise and 1-hour SM) per week. Each class of 10-12 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 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: STRETCH Group
Participants will attend 2x/week for 1 hour each time to ensure this group is matched for attention to STEPPING-UP.
Other: Chair-Based Stretching and Strengthening Program
Participants assigned to this group will receive a 12-week Stretching Program (STRETCH), a group-based exercise control where participants will undertake a seated exercise program that includes: warm up, upper and lower body strengthening, upper and lower body flexibility and some aerobic exercise such as marching.




Primary Outcome Measures :
  1. Walking ability [ Time Frame: Baseline ]
    The Six-Minute Walk Test (6MWT) will be used to quantify walking ability. It measures the distance walked in 6 minutes and is an indicator of exercise capacity and community ambulation.

  2. Change in walking ability from baseline [ Time Frame: 12 weeks ]
    The Six-Minute Walk Test (6MWT) will be used to quantify walking ability. It measures the distance walked in 6 minutes and is an indicator of exercise capacity and community ambulation.


Secondary Outcome Measures :
  1. Change in walking ability from baseline [ Time Frame: 24 weeks ]
    The Six-Minute Walk Test (6MWT) will be used to quantify walking ability. It measures the distance walked in 6 minutes and is an indicator of exercise capacity and community ambulation.

  2. Change in walking ability from baseline [ Time Frame: 36 weeks ]
    The Six-Minute Walk Test (6MWT) will be used to quantify walking ability. It measures the distance walked in 6 minutes and is an indicator of exercise capacity and community ambulation.

  3. Gait speed [ Time Frame: Baseline ]
    An instrumented walkway (Zeno Walkway, Zenometrics) with pressure sensors will allow us accurately measure gait speed.

  4. Change in gait speed from baseline [ Time Frame: 12 weeks ]
    An instrumented walkway (Zeno Walkway, Zenometrics) with pressure sensors will allow us accurately measure gait speed.

  5. Change in gait speed from baseline [ Time Frame: 24 weeks ]
    An instrumented walkway (Zeno Walkway, Zenometrics) with pressure sensors will allow us accurately measure gait speed.

  6. Change in gait speed from baseline [ Time Frame: 36 weeks ]
    An instrumented walkway (Zeno Walkway, Zenometrics) with pressure sensors will allow us accurately measure gait speed.

  7. Self-reported change in mobility [ Time Frame: 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.

  8. Self-reported change in mobility from baseline [ Time Frame: 24 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.

  9. Self-reported change in mobility from baseline [ Time Frame: 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.

  10. Self-efficacy to perform everyday walking tasks [ Time Frame: Baseline ]
    Modified Gait Efficacy Scale (mGES): The mGES will capture an individual's self-efficacy to perform everyday walking tasks. Items are scored individually on a 10-point Likert scale with 1 denoting no confidence and 10 representing complete confidence giving a total score ranging from 10-100 with 100 representing complete confidence in all tasks.

  11. Change in self-efficacy to perform everyday walking tasks from baseline [ Time Frame: 12 weeks ]
    Modified Gait Efficacy Scale (mGES): The mGES will capture an individual's self-efficacy to perform everyday walking tasks. Items are scored individually on a 10-point Likert scale with 1 denoting no confidence and 10 representing complete confidence giving a total score ranging from 10-100 with 100 representing complete confidence in all tasks.

  12. Change in self-efficacy to perform everyday walking tasks from baseline [ Time Frame: 24 weeks ]
    Modified Gait Efficacy Scale (mGES): The mGES will capture an individual's self-efficacy to perform everyday walking tasks. Items are scored individually on a 10-point Likert scale with 1 denoting no confidence and 10 representing complete confidence giving a total score ranging from 10-100 with 100 representing complete confidence in all tasks.

  13. Change in self-efficacy to perform everyday walking tasks from baseline [ Time Frame: 36 weeks ]
    Modified Gait Efficacy Scale (mGES): The mGES will capture an individual's self-efficacy to perform everyday walking tasks. Items are scored individually on a 10-point Likert scale with 1 denoting no confidence and 10 representing complete confidence giving a total score ranging from 10-100 with 100 representing complete confidence in all tasks.

  14. Knowledge, skill and confidence for self-management [ Time Frame: 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).

  15. Change in knowledge, skill and confidence for self-management from baseline [ Time Frame: 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).

  16. Change in knowledge, skill and confidence for self-management from baseline [ Time Frame: 24 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).

  17. Change in knowledge, skill and confidence for self-management from baseline [ Time Frame: 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).

  18. Balance [ Time Frame: Baseline ]
    Mini-Best Test: This balance assessment has 14 items scored on a 3 level ordinal scale (0-2). The maximum score is 28. Higher scores indicate better balance.

  19. Change in balance from baseline [ Time Frame: 12 weeks ]
    Mini-Best Test: This balance assessment has 14 items scored on a 3 level ordinal scale (0-2). The maximum score is 28. Higher scores indicate better balance.

  20. Change in balance from baseline [ Time Frame: 24 weeks ]
    Mini-Best Test: This balance assessment has 14 items scored on a 3 level ordinal scale (0-2). The maximum score is 28. Higher scores indicate better balance.

  21. Change in balance from baseline [ Time Frame: 36 weeks ]
    Mini-Best Test: This balance assessment has 14 items scored on a 3 level ordinal scale (0-2). The maximum score is 28. Higher scores indicate better balance.

  22. Health-related quality of life [ Time Frame: 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).

  23. Change in health-related quality of life from baseline [ Time Frame: 12 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).

  24. Change in health-related quality of life from baseline [ Time Frame: 24 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).

  25. Change in health-related quality of life from baseline [ Time Frame: 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).

  26. Self-efficacy for physical activity: [ Time Frame: 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.

  27. Change in self-efficacy for physical activity from baseline [ Time Frame: 12 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.

  28. Change in self-efficacy for physical activity from baseline [ Time Frame: 24 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.

  29. Change in self-efficacy for physical activity from baseline [ Time Frame: 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.

  30. Emergency room visits [ Time Frame: Baseline to 12 weeks ]
    Healthcare utilization data collected using self-report self-report.

  31. Emergency room visits [ Time Frame: 12 weeks to 24 weeks ]
    Healthcare utilization data collected using self-report self-report.

  32. Emergency room visits [ Time Frame: 24 weeks to 36 weeks ]
    Healthcare utilization data collected using self-report self-report.

  33. Hospitalizations [ Time Frame: Baseline to 12 weeks ]
    Healthcare utilization data collected using self-report self-report.

  34. Hospitalizations [ Time Frame: 12 weeks to 24 weeks ]
    Healthcare utilization data collected using self-report self-report.

  35. Hospitalizations [ Time Frame: 24 weeks to 36 weeks ]
    Healthcare utilization data collected using self-report self-report.

  36. Family doctor visits [ Time Frame: Baseline to 12 weeks ]
    Healthcare utilization data collected using self-report self-report.

  37. Family doctor visits [ Time Frame: 12 weeks to 24 weeks ]
    Healthcare utilization data collected using self-report self-report.

  38. Family doctor visits [ Time Frame: 24 weeks to 36 weeks ]
    Healthcare utilization data collected using self-report self-report.

  39. Specialist physician visits visits [ Time Frame: Baseline to 12 weeks ]
    Healthcare utilization data collected using self-report self-report.

  40. Specialist physician visits visits [ Time Frame: 12 weeks to 24 weeks ]
    Healthcare utilization data collected using self-report self-report.

  41. Specialist physician visits visits [ Time Frame: 24 weeks to 36 weeks ]
    Healthcare utilization data collected using self-report self-report.

  42. Medical tests or procedures [ Time Frame: Baseline to 12 weeks ]
    Healthcare utilization data collected using self-report self-report.

  43. Medical tests or procedures [ Time Frame: 12 weeks to 24 weeks ]
    Healthcare utilization data collected using self-report self-report.

  44. Medical tests or procedures [ Time Frame: 24 weeks to 36 weeks ]
    Healthcare utilization data collected using self-report self-report.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, walking 0.5km, and climbing up 1 flight of stairs). 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

Exclusion Criteria:

  1. Any errors on the 6 item telephone screen
  2. A score of ≤24 points on the Mini Mental Status Exam during face-to-face assessment
  3. Major illness that would prevent participation
  4. Leaving the geographic area in the next 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368949


Contacts
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Contact: Susanne Sinclair, BHScPT 905-525-9140 ext 27810 ssincla@mcmaster.ca

Locations
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Canada, Ontario
Sackville Hill Seniors Recreation Centre
Hamilton, Ontario, Canada, L9A 4V5
Contact: Eleanor Morton    905-546-2424 ext 3743    Eleanor.Morton@hamilton.ca   
Les Chater Family YMCA
Hamilton, Ontario, Canada, L9B1C2
Contact: Genevieve Hladysh    905-667-1515 ext 8033    genevieve_hladysh@ymca.ca   
Sponsors and Collaborators
McMaster University
YMCA Hamilton/Burlington/Brantford
City of Hamilton
Investigators
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Principal Investigator: Julie Richardson, PhD McMaster University
Principal Investigator: Ayse Kuspinar, PhD McMaster University
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Responsible Party: Julie Richardson, Principal Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT04368949    
Other Study ID Numbers: PJT-169034
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Richardson, McMaster University:
Preclinical mobility limitation
Walking ability
Physical function
Task-oriented motor learning
Self-management
Additional relevant MeSH terms:
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Mobility Limitation