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Active, Not Recruiting

NCT Number: NCT04368949

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stepping-Up

Other

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

Other

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

Other

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 outcomes

  1. Walking speed

    Time frame: 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.

  2. Change in walking speed from baseline

    Time frame: 12 weeks

    The 4-Metre Gait Speed Test (4MGS) is a performance-based measure of walking speed. The 4MGS test will be performed from a standing start at both a self-selected (usual) and fastest walking speed.

Secondary outcomes

  1. Change in walking speed from baseline

    Time frame: 24 weeks

    The 4-Metre Gait Speed Test (4MGS) is a performance-based measure of walking speed. The 4MGS test will be performed from a standing start at both a self-selected (usual) and fastest walking speed.

  2. Change in walking speed from baseline

    Time frame: 36 weeks

    The 4-Metre Gait Speed Test (4MGS) is a performance-based measure of walking speed. The 4MGS test will be performed from a standing start at both a self-selected (usual) and fastest walking speed.

  3. Exercise capacity

    Time frame: 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.

  4. Change in exercise capacity from baseline

    Time frame: 12 weeks

    2-Minute Step Test (TMST): The TMST is a test of exercise capacity that can be used as an alternative to a timed long-distance walking test when assessment space is limited. Individuals are required to march in place as quickly as possible for 2 minutes while lifting their knees to a height midway between their patella and iliac crest when standing.

  5. Change in exercise capacity from baseline

    Time frame: 24 weeks

    2-Minute Step Test (TMST): The TMST is a test of exercise capacity that can be used as an alternative to a timed long-distance walking test when assessment space is limited. Individuals are required to march in place as quickly as possible for 2 minutes while lifting their knees to a height midway between their patella and iliac crest when standing.

  6. Change in exercise capacity from baseline

    Time frame: 36 weeks

    2-Minute Step Test (TMST): The TMST is a test of exercise capacity that can be used as an alternative to a timed long-distance walking test when assessment space is limited. Individuals are required to march in place as quickly as possible for 2 minutes while lifting their knees to a height midway between their patella and iliac crest when standing.

  7. Lower body strength

    Time frame: 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.

  8. Change in lower body strength from baseline

    Time frame: 12 weeks

    30-Second Chair Stand Test (CST): The 30-Second CST is used to assess lower body strength and power and is measured by the number of chair stand repetitions in a 30-second period.

  9. Change in lower body strength from baseline

    Time frame: 24 weeks

    30-Second Chair Stand Test (CST): The 30-Second CST is used to assess lower body strength and power and is measured by the number of chair stand repetitions in a 30-second period.

  10. Change in lower body strength from baseline

    Time frame: 36 weeks

    30-Second Chair Stand Test (CST): The 30-Second CST is used to assess lower body strength and power and is measured by the number of chair stand repetitions in a 30-second period.

  11. Dual task cost

    Time frame: Baseline

    Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.

  12. Change in dual task cost from baseline

    Time frame: 12 weeks

    Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.

  13. Change in dual task cost from baseline

    Time frame: 24 weeks

    Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.

  14. Change in dual task cost from baseline

    Time frame: 36 weeks

    Difference in time between the Timed Up and Go (TUG) and the TUG Cognitive.

  15. 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.

  16. Change in self-reported change in mobility from basseline

    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.

  17. Change in self-reported change in mobility from basseline

    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.

  18. Balance self-efficacy

    Time frame: 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).

  19. Change in balance self-efficacy from baseline

    Time frame: 12 weeks

    Activities-specific Balance Confidence (ABC) Scale: The ABC Scale is a self-report measure of balance confidence. Individuals are asked to rate their confidence in completing 16 common tasks without losing balance, on a scale from 0% (no confidence) to 100% (complete confidence).

  20. Change in balance self-efficacy from baseline

    Time frame: 24 weeks

    Activities-specific Balance Confidence (ABC) Scale: The ABC Scale is a self-report measure of balance confidence. Individuals are asked to rate their confidence in completing 16 common tasks without losing balance, on a scale from 0% (no confidence) to 100% (complete confidence).

  21. Change in balance self-efficacy from baseline

    Time frame: 36 weeks

    Activities-specific Balance Confidence (ABC) Scale: The ABC Scale is a self-report measure of balance confidence. Individuals are asked to rate their confidence in completing 16 common tasks without losing balance, on a scale from 0% (no confidence) to 100% (complete confidence).

  22. Mobility patterns

    Time frame: 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.

  23. Change in mobility patterns from baseline

    Time frame: 12 weeks

    The Life-Space Assessment (LSA): The LSA measures a person's usual pattern of mobility during a 1-month period, documenting mobility based on how far and how often a person travels and any assistance required.

  24. Change in mobility patterns from baseline

    Time frame: 24 weeks

    The Life-Space Assessment (LSA): The LSA measures a person's usual pattern of mobility during a 1-month period, documenting mobility based on how far and how often a person travels and any assistance required.

  25. Change in mobility patterns from baseline

    Time frame: 36 weeks

    The Life-Space Assessment (LSA): The LSA measures a person's usual pattern of mobility during a 1-month period, documenting mobility based on how far and how often a person travels and any assistance required.

  26. 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).

  27. 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).

  28. 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).

  29. 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).

  30. Balance

    Time frame: 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.

  31. Change in balance from baseline

    Time frame: 12 weeks

    Unipedal Stance Test (UPST): The UPST is used to assess static balance. 68 Individuals are asked to stand barefoot on the limb of their choice until they (1) use their arms (i.e., uncross arms), (2) use their raised foot (i.e., move it toward or away from the standing limb or touched the floor), (3) move the weight-bearing foot to maintain their balance (i.e., rotate foot on the ground) or (4) maintain the position for a maximum of 45 seconds.

  32. Change in balance from baseline

    Time frame: 24 weeks

    Unipedal Stance Test (UPST): The UPST is used to assess static balance. 68 Individuals are asked to stand barefoot on the limb of their choice until they (1) use their arms (i.e., uncross arms), (2) use their raised foot (i.e., move it toward or away from the standing limb or touched the floor), (3) move the weight-bearing foot to maintain their balance (i.e., rotate foot on the ground) or (4) maintain the position for a maximum of 45 seconds.

  33. Change in balance from baseline

    Time frame: 36 weeks

    Unipedal Stance Test (UPST): The UPST is used to assess static balance. 68 Individuals are asked to stand barefoot on the limb of their choice until they (1) use their arms (i.e., uncross arms), (2) use their raised foot (i.e., move it toward or away from the standing limb or touched the floor), (3) move the weight-bearing foot to maintain their balance (i.e., rotate foot on the ground) or (4) maintain the position for a maximum of 45 seconds.

  34. 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).

  35. 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).

  36. 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).

  37. 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).

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. Self-reported mobility

    Time frame: 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.

  43. Change in self-reported mobility from baseline

    Time frame: 12 weeks

    Mobility Assessment Tool (MAT-sf): The MAT-sf is a video-animated tool for assessing mobility. It consists of 10 animated video clips that assess an individuals' perceived level of proficiency in performing each task.

  44. Change in self-reported mobility from baseline

    Time frame: 24 weeks

    Mobility Assessment Tool (MAT-sf): The MAT-sf is a video-animated tool for assessing mobility. It consists of 10 animated video clips that assess an individuals' perceived level of proficiency in performing each task.

  45. Change in self-reported mobility from baseline

    Time frame: 36 weeks

    Mobility Assessment Tool (MAT-sf): The MAT-sf is a video-animated tool for assessing mobility. It consists of 10 animated video clips that assess an individuals' perceived level of proficiency in performing each task.

  46. Emergency room visits

    Time frame: Baseline to 12 weeks

    Healthcare utilization data collected using self-report self-report.

  47. Emergency room visits

    Time frame: 12 weeks to 24 weeks

    Healthcare utilization data collected using self-report self-report.

  48. Emergency room visits

    Time frame: 24 weeks to 36 weeks

    Healthcare utilization data collected using self-report self-report.

  49. Hospitalizations

    Time frame: Baseline to 12 weeks

    Healthcare utilization data collected using self-report self-report.

  50. Hospitalizations

    Time frame: 12 weeks to 24 weeks

    Healthcare utilization data collected using self-report self-report.

  51. Hospitalizations

    Time frame: 24 weeks to 36 weeks

    Healthcare utilization data collected using self-report self-report.

  52. Family doctor visits

    Time frame: Baseline to 12 weeks

    Healthcare utilization data collected using self-report self-report.

  53. Family doctor visits

    Time frame: 12 weeks to 24 weeks

    Healthcare utilization data collected using self-report self-report.

  54. Family doctor visits

    Time frame: 24 weeks to 36 weeks

    Healthcare utilization data collected using self-report self-report.

  55. Specialist physician visits visits

    Time frame: Baseline to 12 weeks

    Healthcare utilization data collected using self-report self-report.

  56. Specialist physician visits visits

    Time frame: 12 weeks to 24 weeks

    Healthcare utilization data collected using self-report self-report.

  57. Specialist physician visits visits

    Time frame: 24 weeks to 36 weeks

    Healthcare utilization data collected using self-report self-report.

  58. Medical tests or procedures

    Time frame: Baseline to 12 weeks

    Healthcare utilization data collected using self-report self-report.

  59. Medical tests or procedures

    Time frame: 12 weeks to 24 weeks

    Healthcare utilization data collected using self-report self-report.

  60. Medical tests or procedures

    Time frame: 24 weeks to 36 weeks

    Healthcare utilization data collected using self-report self-report.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • City of Hamilton
  • YMCA Hamilton/Burlington/Brantford

Registry information

Acronym: Stepping-Up

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Apr 30, 2020
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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