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Behavioural Intervention

Exercise Program for Limited Mobility

N/A

Recruiting

Led By Nancy Salbach, PhD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mobility limitations such as need to use a walking aid, difficulty stepping onto curbs, ramps, stairs, or walk on uneven surfaces

Able to stand up from and sit down onto a chair independently, without supervision

Must not have

Severe visual impairment

Severe hearing impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the effects of a virtual group exercise program called TIME™ at Home with a control group in adults with balance and mobility limitations. The trial will assess if the exercise program improves physical

Who is the study for?

This trial is for adults over 18 with limited mobility who live independently and can stand, sit, and walk at least 10 meters without help but may use walking aids. They must speak English, have a caregiver to assist during evaluations via Zoom, and be able to follow exercise instructions.

What is being tested?

The TIME™ at Home trial tests an 8-week virtual group exercise program against a waitlist control to see if it improves balance, mobility, mental health outcomes for participants and mood of caregivers. It also examines the influence of sex/gender on experiences and costs involved.

What are the potential side effects?

Since this is an exercise-based intervention conducted virtually through Zoom, side effects are not typical as in drug trials but may include general discomfort or minor injuries related to physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need help walking or have trouble with stairs and uneven surfaces.

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I can sit and stand from a chair by myself.

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I can walk at least 10 meters on my own, with aids if needed.

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I have someone who can join me for a Zoom call during my first evaluation.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe difficulty seeing.

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I have severe hearing loss.

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I have health issues that stop me from exercising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months

Secondary study objectives

2-minute step test (2ST)

3-metre walk test (3mWT, comfortable pace)

3-metre walk test (3mWT, fast pace)

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TIME at HomeExperimental Treatment1 Intervention

TIME at Home is a virtual, group, task-oriented exercise program targeting balance and mobility. A community organization delivers two 1.5-hour sessions per week, for 8 weeks using Zoom.

Group II: WaitlistActive Control1 Intervention

Individuals in the waitlist control group will receive the TIME at Home program following the final 5-month evaluation.

0 / 8Eligibility criteria met