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

249 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Chair-Based Yoga Program, Stepping-Up, Telephone-Based Coaching Walking Program?

Research shows that walking programs like STRIDE can help reduce the negative effects of immobility in hospitalized patients, such as loss of function and increased need for care after leaving the hospital. This suggests that similar programs, like the Stepping-Up intervention, may also be effective in improving mobility and reducing these negative outcomes. ^{1 2 3 4 5}

Is the Stepping-Up Intervention for Limited Mobility safe for humans?

The Stepping-Up Intervention, including similar programs like Chair-Based Yoga and Telephone-Based Coaching Walking Program, has been generally safe in humans. Studies show no serious adverse events, with only a few minor issues like muscle strains, emphasizing the importance of starting slowly and gradually increasing activity. ^{6 7 8 9 10}

How is the Stepping-Up treatment different from other treatments for limited mobility?

The Stepping-Up treatment is unique because it focuses on enhancing physical activity through tailored advice from physiotherapists, based on behavior change theories, making it affordable and scalable for adults with mobility limitations. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Julie Richardson, PhD

Principal Investigator

McMaster University

Ayse Kuspinar, PhD

Principal Investigator

McMaster University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Early Mobility in the Hospital: Lessons Learned from the STRIDE Program. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Inactive and alone: physical activity within the first 14 days of acute stroke unit care. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Early Mobilization in the ICU: A Collaborative, Integrated Approach. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Impact of an INtervention to increase MOBility in older hospitalized medical patients (INTOMOB): Study protocol for a cluster randomized controlled trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Measuring change in gait performance of children with motor disorders: assessing the Functional Mobility Scale and the Gillette Functional Assessment Questionnaire walking scale. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Step training improves reaction time, gait and balance and reduces falls in older people: a systematic review and meta-analysis. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Motor Control and Ergonomic Intervention Home-Based Program: A Pilot Trial Performed in the Framework of the Motor Control Home Ergonomics Elderlies' Prevention of Falls (McHeELP) Project. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness and sustainability of a motor-cognitive stepping exergame training on stepping performance in older adults: a randomized controlled trial. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Short and long-term effects of exergaming for the elderly. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial. [2021]

12. Sweden pubmed.ncbi.nlm.nih.gov

Mobility devices to promote activity and participation: a systematic review. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Use of a device to support standing during a physical activity program to improve function of individuals with disabilities who reside in a nursing home. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

In frail older adults with sarcopenia, a multicomponent intervention vs. education reduced mobility disability at 26 mo. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Effect of a multifactorial interdisciplinary intervention on mobility-related disability in frail older people: randomised controlled trial. [2022]