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Mobility LimitationStepping-UpNCT04368949

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

A study testing Stepping-Up, Telephone-Based Coaching Walking Program and Chair-Based Yoga Program in people with Mobility Limitation, run by McMaster University at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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). Read more about this study

Who is it for?
Ages 55 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Mobility Limitation
What is being tested?
Stepping-Up, Telephone-Based Coaching Walking Program and Chair-Based Yoga Program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
249 participants
Where
1 siteCanada
Study dates
1 Apr 2021to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • A score of <11 on the MoCA 5-Minute telephone screen
  • Major illness that would prevent participation

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McMaster University

    Hamilton, Ontario, L8S 1C7

Other trials in Canada

About this study

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.

Being tested
Stepping-Up, Telephone-Based Coaching Walking Program, Chair-Based Yoga Program
Keywords
Preclinical mobility limitation, Walking ability, Physical function, Task-oriented motor learning, Self-management
Medical subject headings
Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stepping-UpOther

    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 ProgramOther

    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 ProgramOther

    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.

Study groups in NCT04368949
Study groupRoleWhat they receive
Stepping-Up GroupExperimentalParticipants 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.
Receives: Other: Stepping-Up
TELE GroupActive comparatorThe initial telephone session will be 20-30 minutes, with subsequent weekly calls will be approximately 10 minutes.
Receives: Other: Telephone-Based Coaching Walking Program
Chair-Based Yoga GroupPlacebo comparatorParticipants will attend two 1-hour virtual sessions per week to ensure this group is matched for attention to STEPPING-UP.
Receives: Other: Chair-Based Yoga Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: 12 weeks

Secondary outcomes (60)
  1. 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.

    Measured: 24 weeks

  2. 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.

    Measured: 36 weeks

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: 12 weeks

  5. 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.

    Measured: 24 weeks

  6. 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.

    Measured: 36 weeks

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: 12 weeks

  9. 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.

    Measured: 24 weeks

  10. 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.

    Measured: 36 weeks

  11. Dual task cost

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

    Measured: Baseline

  12. Change in dual task cost from baseline

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

    Measured: 12 weeks

  13. Change in dual task cost from baseline

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

    Measured: 24 weeks

  14. Change in dual task cost from baseline

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

    Measured: 36 weeks

  15. 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.

    Measured: 12 weeks

  16. 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.

    Measured: 24 weeks

  17. 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.

    Measured: 36 weeks

  18. 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).

    Measured: Baseline

  19. 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).

    Measured: 12 weeks

  20. 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).

    Measured: 24 weeks

  21. 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).

    Measured: 36 weeks

  22. 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.

    Measured: Baseline

  23. 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.

    Measured: 12 weeks

  24. 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.

    Measured: 24 weeks

  25. 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.

    Measured: 36 weeks

  26. 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).

    Measured: 12 weeks

  27. 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).

    Measured: Baseline

  28. 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).

    Measured: 24 weeks

  29. 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).

    Measured: 36 weeks

  30. 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.

    Measured: Baseline

  31. 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.

    Measured: 12 weeks

  32. 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.

    Measured: 24 weeks

  33. 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.

    Measured: 36 weeks

  34. 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).

    Measured: Baseline

  35. 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).

    Measured: 12 weeks

  36. 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).

    Measured: 24 weeks

  37. 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).

    Measured: 36 weeks

  38. 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.

    Measured: Baseline

  39. 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.

    Measured: 12 weeks

  40. 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.

    Measured: 24 weeks

  41. 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.

    Measured: 36 weeks

  42. 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.

    Measured: Baseline

  43. 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.

    Measured: 12 weeks

  44. 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.

    Measured: 24 weeks

  45. 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.

    Measured: 36 weeks

  46. Emergency room visits

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

    Measured: Baseline to 12 weeks

  47. Emergency room visits

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

    Measured: 12 weeks to 24 weeks

  48. Emergency room visits

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

    Measured: 24 weeks to 36 weeks

  49. Hospitalizations

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

    Measured: Baseline to 12 weeks

  50. Hospitalizations

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

    Measured: 12 weeks to 24 weeks

  51. Hospitalizations

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

    Measured: 24 weeks to 36 weeks

  52. Family doctor visits

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

    Measured: Baseline to 12 weeks

  53. Family doctor visits

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

    Measured: 12 weeks to 24 weeks

  54. Family doctor visits

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

    Measured: 24 weeks to 36 weeks

  55. Specialist physician visits visits

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

    Measured: Baseline to 12 weeks

  56. Specialist physician visits visits

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

    Measured: 12 weeks to 24 weeks

  57. Specialist physician visits visits

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

    Measured: 24 weeks to 36 weeks

  58. Medical tests or procedures

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

    Measured: Baseline to 12 weeks

  59. Medical tests or procedures

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

    Measured: 12 weeks to 24 weeks

  60. Medical tests or procedures

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

    Measured: 24 weeks to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2020
  2. Study start1 Apr 2021
  3. Primary completion1 Oct 2025
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
249 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04368949
Sponsor's protocol ID
PJT-169034
Acronym
Stepping-Up
Status last verified
Jun 2026
First submitted
23 Apr 2020
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Richardson J, Kuspinar A, Sinclair S, Beauchamp M, Dufour S, Tang A, MacDermid J, Durocher E, Thabane L, Xie F, Costa A. Effect of an Online Mobility Self-Management Program on Walking Speed in Older Adults With Preclinical Mobility Limitation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 21;14:e72585. doi: 10.2196/72585.

    PubMed 40397951

Questions about this trial

What is this clinical trial studying?

A study testing Stepping-Up, Telephone-Based Coaching Walking Program and Chair-Based Yoga Program in people with Mobility Limitation, run by McMaster University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Walking speed (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04368949, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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