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

NCT04368949 | Active Not Recruiting

• 1 other identifier: PJT-169034
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobility Limitation

Keywords

Preclinical mobility limitation; Walking ability; Physical function; Task-oriented motor learning; Self-management

Outcome Measures

Primary Outcomes (2)

• Walking speed

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

  Baseline

• Change in walking speed from baseline

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

  12 weeks

Secondary Outcomes (60)

• Change in walking speed from baseline

  24 weeks

• Change in walking speed from baseline

  36 weeks

• Exercise capacity

  Baseline

• Change in exercise capacity from baseline

  12 weeks

• Change in exercise capacity from baseline

  24 weeks

Study Arms (3)

Stepping-Up Group

EXPERIMENTAL

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.

Other: Stepping-Up

TELE Group

ACTIVE COMPARATOR

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

Other: Telephone-Based Coaching Walking Program

Chair-Based Yoga Group

PLACEBO COMPARATOR

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

Other: Chair-Based Yoga Program

Interventions

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.

Stepping-Up Group

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.

TELE Group

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.

Chair-Based Yoga Group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• YMCA Hamilton/Burlington/Brantford: collaborator
• City of Hamilton: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

Related Publications (1)

• 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.

  PMID: 40397951 DERIVED

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Richardson, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Ayse Kuspinar, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 30, 2020
• Study Start: April 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: April 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)