Stepping-Up Intervention for Limited Mobility

(Stepping-Up Trial)

Overseen By Susanne Sinclair, BHScPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Cognitive impairment, Major illness, others

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called STEPPING-UP, designed to assist individuals with early signs of mobility issues, such as slower walking or quick fatigue. The goal is to enhance walking ability and prevent future mobility problems, which can lead to serious health issues. Participants will either join the STEPPING-UP group, engage in chair-based yoga, or receive phone check-ins through a telephone-based coaching walking program. It suits community-dwelling individuals in Ontario, Canada, aged 55-75, who notice changes in their walking but do not have major difficulties. Participants need access to a computer and the internet for virtual sessions. As an unphased trial, this study provides a unique opportunity to contribute to innovative research aimed at enhancing mobility and overall health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Stepping-Up program is generally safe. Similar programs, such as Chair-Based Yoga and Telephone-Based Coaching, have also proven to be safe. In studies of the Telephone-Based Coaching Walking Program, researchers reported no major safety issues, indicating it is well-tolerated. These findings suggest that both Stepping-Up and similar programs are safe options for improving mobility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stepping-Up intervention for limited mobility because it combines personalized exercise routines with self-management strategies in a virtual setting. This approach is unique because, unlike traditional mobility treatments that often require in-person sessions, Stepping-Up offers flexibility by allowing participants to join from home. Moreover, the involvement of both a physiotherapist and a kinesiologist ensures that exercises are individually tailored, potentially improving effectiveness and engagement. This innovative method aims to address mobility challenges in a more accessible and personalized way, which could significantly enhance the quality of life for individuals with limited mobility.

What evidence suggests that this trial's treatments could be effective for improving mobility in persons with PCML?

Research has shown that the Stepping-Up program, which participants in this trial may receive, can help people walk faster and improve their aerobic exercise ability. In a previous study, participants in a 12-week online program to manage their mobility independently achieved better results. They walked faster and could perform more tasks while walking. Another study found that better mobility is linked to improved health in older adults.

The phone-based coaching program, another treatment arm in this trial, has shown mixed results in studies. Some research indicates it helps people walk better, while other studies find it doesn't significantly improve home exercise routines for older adults. However, the coaching aims to reduce sitting time and increase movement, potentially leading to better mobility over time. ^{1 2 5 6 7}

Who Is on the Research Team?

Julie Richardson, PhD

Principal Investigator

McMaster University

Ayse Kuspinar, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for people aged 55-75 living in Ontario, Canada who have early signs of mobility decline but can still do daily tasks like walking. They must understand English, own a laptop with internet and email to use Zoom©, and not have any major illnesses that would stop them from participating.

Inclusion Criteria

Understanding of spoken and written English

I am between 55 and 75 years old.

Own a laptop computer, have an email address and have internet capabilities of running the video-conferencing platform, Zoom©

Exclusion Criteria

A score of <11 on the MoCA 5-Minute telephone screen

I do not have any major illnesses that would stop me from joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will attend virtual sessions for exercise and self-management tailored by a Physiotherapist and kinesiologist

12 weeks

1-2 virtual sessions per week

Follow-up

Participants are monitored for changes in mobility and healthcare utilization

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chair-Based Yoga Program
• Stepping-Up
• Telephone-Based Coaching Walking Program

Trial Overview The study tests a new program called STEPPING-UP aimed at improving walking ability in older adults with preclinical mobility limitations. It includes chair-based yoga, telephone coaching, and a walking program to see if these can prevent early mobility decline.

How Is the Trial Designed?

Group I: Stepping-Up Group Experimental Treatment 1 Intervention

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.

Group II: TELE Group Active Control 1 Intervention

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

Group III: Chair-Based Yoga Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

City of Hamilton

Collaborator

Trials

1

Recruited

250+

YMCA Hamilton/Burlington/Brantford

Collaborator

Trials

1

Recruited

250+

Published Research Related to This Trial

In a study of 64 stroke patients observed over two days, it was found that more than 50% of their time was spent resting in bed, with only 13% engaged in activities that could help prevent complications and improve mobility.

The findings highlight the need for a randomized controlled trial to test the effectiveness of increased physical activity in stroke patients, as current levels of activity are low and may hinder recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inactive and alone: physical activity within the first 14 days of acute stroke unit care. Bernhardt, J., Dewey, H., Thrift, A., et al.[2022]

A 12-month multifactorial intervention significantly improved mobility-related disability in 241 frail older adults, as evidenced by better scores on the Goal Attainment Scale and Life Space Assessment compared to the control group.

Participants in the intervention group also demonstrated a slight increase in walking speed and higher scores on activity measures, indicating enhanced mobility and participation in daily life activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a multifactorial interdisciplinary intervention on mobility-related disability in frail older people: randomised controlled trial. Fairhall, N., Sherrington, C., Kurrle, SE., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04368949

Stepping-Up: Partnering with the Community to Prevent ... This study will evaluate a novel intervention, STEPPING-UP, for improving walking ability in persons with PCML. Official Title. Stepping-Up: Partnering with the ...

2. withpower.com withpower.com/trial/phase-mobility-limitation-3-2021-a2190

Stepping-Up Intervention for Limited Mobility In a study of 64 stroke patients observed over two days, it was found that more than 50% of their time was spent resting in bed, with only 13% engaged in ...

3. researchprotocols.org researchprotocols.org/2025/1/e72585

Effect of an Online Mobility Self-Management Program on ... A 12-week online mobility self-management program (Stepping Up) on mobility outcomes, including walking speed, aerobic exercise capacity, dual-task cost, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7662180/

Association Between Improved Mobility and Distal ... We examined the association between improved mobility and distal health outcomes in older adults using secondary analysis of data from a cluster-randomized ...

5. exponent.com exponent.com/article/stepping-gait-mobility-outcomes-wearables

Stepping Up Gait & Mobility Outcomes with Wearables Gait and mobility tracking with wearables can generate high-quality real-world data for assessing clinical intervention efficacies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6832707/

Stepping Up to Rethink the Future of Rehabilitation: IV ... The desired outcomes of physical therapy intervention include better motor skills; better health; prevention of impairments; and measuring whether or not the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04714840

NCT04714840 | Telehealth Based Intervention to Improve ... Telehealth Based Intervention to Improve Functional Capacity in Survivors of Childhood Cancer With Significantly Limited Exercise Tolerance · Study Overview.