Exercise Program for Limited Mobility

Recruiting at 3 trial locations

Overseen By Renato Barbosa dos Santos, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Formal exercise, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an exercise program called TIME™ at Home for individuals with balance and mobility issues, such as those needing a walking aid or having difficulty with stairs. The study aims to determine if this virtual program can improve physical and mental health compared to those on a waiting list. Researchers also seek to understand how factors like mobility level, sex, or gender affect the results and assess the program's costs for both participants and the organization. To join, participants must be able to walk 10 meters independently and require a caregiver for daily activities. Participants will attend Zoom sessions to evaluate their progress over several months. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for those with mobility challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on exercise and mobility, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that the TIME™ at Home exercise program is safe for individuals with balance and mobility limitations?

Research has shown that TIME™ at Home is safe for people with balance and mobility issues. In one study, 17 participants with an average age of 73 tried the program and reported no major problems or side effects. Another study confirmed the program's practicality and safety, offering benefits for both physical and mental health. Participants experienced improvements in leg strength and balance without serious safety concerns. Overall, these findings suggest that the TIME™ at Home program is a safe choice for those seeking to improve balance and mobility from home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TIME™ at Home program because it offers a unique approach to improving balance and mobility for individuals with limited mobility by delivering exercises virtually. Unlike traditional physical therapy, which often requires in-person sessions, TIME™ at Home leverages technology, allowing participants to engage in group, task-oriented exercises from the comfort of their homes via Zoom. This accessibility can help overcome barriers like transportation issues or limited availability of local programs, potentially making it more convenient and inclusive. Additionally, the social aspect of virtual group sessions may enhance motivation and adherence, offering a supportive community environment and potentially leading to better outcomes.

What evidence suggests that the TIME™ at Home exercise program is effective for improving balance and mobility?

Research has shown that the TIME™ at Home exercise program, available to participants in this trial, can enhance physical health for individuals with mobility issues. One study found that participants experienced noticeable improvements in leg strength and balance. These benefits appeared in a group with an average age of 73, where more than half had suffered a stroke. The program is designed for safe and effective home use through online sessions, making it easily accessible and potentially beneficial for improving mobility and overall well-being. ^{1 2 3 5 6}

Who Is on the Research Team?

Nancy Salbach, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can keep my balance while exercising if I hold onto something stable.

Able to speak and read English to understand informed consent and follow instructions for study procedures and exercises

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

Exclusion Criteria

Involvement in another formal exercise or rehabilitation program in the next 2 months

Previous participation in the TIME at Home exercise program

Cognitive impairment, defined as a score of <11/15 on the 5-minute Montreal Cognitive Assessment (MoCA)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the 8-week TIME™ at Home exercise program, delivered virtually via Zoom, focusing on balance and mobility

8 weeks

16 sessions (virtual)

Waitlist Control

Participants in the control group wait for 5 months before starting the exercise program

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 evaluations (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• TIME™ at Home

Trial Overview

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.

How Is the Trial Designed?

Group I: TIME at Home Experimental Treatment 1 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: Waitlist Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Bruyere Research Institute

Collaborator

Trials

35

Recruited

2,024,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

University of Manitoba

Collaborator

Trials

628

Recruited

209,000+

March of Dimes, Canada

Collaborator

Trials

3

Recruited

260+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Bruyère Health Research Institute.

Collaborator

Published Research Related to This Trial

Participants with chronic health conditions expressed that adverse events (AEs) from resistance training (RT) significantly impact their willingness to engage in future exercise, highlighting the importance of understanding both the risks and benefits of RT.

The study identified that personal experiences, health conditions, and the environment in which RT occurs influence perceptions of safety and participation, suggesting that better communication about the risks of AEs is essential to encourage RT among individuals with chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2023]

A 12-week home exercise program using transtelephonic exercise monitoring (TEM) was found to be effective for cardiac rehabilitation, showing significant improvements in cardiac function for both home and hospital-based groups.

While two patients in the TEM group experienced new arrhythmias requiring medication adjustments, there were no medical emergencies, indicating that TEM can be a safe alternative for patients unable to attend hospital-based rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternatives for cardiac rehabilitation patients unable to return to a hospital-based program. Sparks, KE., Shaw, DK., Eddy, D., et al.[2007]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

A home-based exercise program for patients with systolic heart failure did not improve overall clinical outcomes after 12 months, as measured by hospitalizations, emergency admissions, and mortality.

However, the exercise group experienced significantly fewer multiple hospitalizations (12.8% vs. 26.6% in the control group), indicating a potential benefit in reducing the frequency of hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a home-based exercise program on clinical outcomes in heart failure. Dracup, K., Evangelista, LS., Hamilton, MA., et al.[2007]

A low-cost, home-based pulmonary rehabilitation program for 29 subjects with COPD significantly improved exercise capacity, as evidenced by a 65-meter increase in the 6-minute walk test and a 316.6-meter increase in treadmill endurance after 24 sessions.

Participants in the rehabilitation program also reported better quality of life, with over a 4-unit decrease in all domains of the St George Respiratory Questionnaire, while the control group showed no improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Pulmonary Rehabilitation for Subjects With COPD: A Randomized Study. Pradella, CO., Belmonte, GM., Maia, MN., et al.[2022]

A home-based exercise program for frail elderly patients recovering from hip fractures was found to be feasible, with 82% of participants receiving follow-up from trainers and most advancing in their exercise levels.

The program, which included both strength training and aerobic components, achieved a high participation rate, with participants completing an average of 78.5% of their scheduled training sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a home-based exercise program post-hip fracture: the Baltimore hip studies experience. Yu-Yahiro, JA., Resnick, B., Orwig, D., et al.[2021]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

In a study of 155 Service Members undergoing physical therapy in Iraq and Afghanistan, it was found that those prescribed 4 or more home exercises had a lower compliance rate compared to those with 2 or fewer exercises, indicating that fewer exercises may lead to better adherence.

Additionally, Service Members who left the base at least once a week also showed lower compliance rates, suggesting that external factors may impact their ability to follow through with prescribed exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home exercise program compliance of service members in the deployed environment: an observational cohort study. Eckard, T., Lopez, J., Kaus, A., et al.[2022]

The Functional Maintenance Program (FMP) was successfully implemented for older hospitalized patients, with 89% of those identified starting the program within 48 hours, indicating high feasibility for tailored exercise interventions.

Patients participating in the FMP showed a significantly lower likelihood of needing nursing home referrals and residential care approvals, suggesting that early exercise programs may help maintain independence and functional mobility in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted individual exercise programmes for older medical patients are feasible, and may change hospital and patient outcomes: a service improvement project. Nolan, J., Thomas, S.[2022]

A randomized controlled trial is set to evaluate a 12-week home-based exercise program for patients aged 70 and older, aiming to improve functional lower body strength and overall physical functioning.

The program, delivered through general practitioners and exercise therapists, is based on behavior change strategies and will assess various outcomes, including physical activity levels and health-related quality of life, to determine its effectiveness compared to a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an exercise programme for chronically ill and mobility-restricted elderly with structured support by the general practitioner's practice (HOMEfit) - study protocol of a randomised controlled trial. Hinrichs, T., Moschny, A., Brach, M., et al.[2023]

Home-based exercise programs for older adults can significantly reduce the fear of falling, providing moderately certain evidence of their effectiveness based on a systematic review of 11 studies involving 1004 participants.

These programs also show potential for improving psychosocial outcomes, such as mental health and quality of life, as well as mobility, although the evidence for these benefits is less certain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Indoor Physical Activity Programs for Community-Dwelling Older Adults: A Systematic Review. Santos, IKD., Cobucci, RN., Medeiros, JA., et al.[2023]

A study involving 150 older adult Veterans showed that both progressive high-intensity resistance training and standardized physical therapy improved physical function, particularly gait speed, after hospitalization, but neither was superior to the other.

The high-intensity training program was found to be safe, with no significant differences in adverse events like rehospitalizations or falls compared to the standardized program, indicating that both approaches are beneficial for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity home health physical therapy among older adult Veterans: A randomized controlled trial. Stevens-Lapsley, JE., Derlein, D., Churchill, L., et al.[2023]

A blended intervention combining a tablet app and personal coaching was developed to help older adults exercise at home, incorporating behavior change techniques to enhance motivation and adherence.

The program includes features like goal setting, personalized training schedules, and remote feedback, making it a convenient and effective way for older adults to maintain physical activity and independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating Behavior Change Principles Into a Blended Exercise Intervention for Older Adults: Design Study. Mehra, S., Visser, B., Dadema, T., et al.[2020]

Citations

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In 17 participants with pre and post data (median age 73 years, 53% post-stroke), significant improvement on measures of leg strength, balance ...

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Feasibility, safety, and potential benefit of a virtual ...

TIMETM at Home combines a prerecorded video of exercises selected from the in-person program deemed safe for adults with mobility limitations to perform at home ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05725564

Testing Interventions for Mobility Through Exercise (TIME)

In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12306342/

Short-term effects of a virtual, community-based, task-oriented ...

The study objective is to estimate the short-term effect of an 8-week, virtual, group, task-oriented CBEP called TIME™ (Together in Movement and ...

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pcori.org

pcori.org/research-results/2016/comparing-clinic-based-versus-home-based-exercise-programs-among-people-multiple-sclerosis-teams-study

Comparing Clinic-Based versus Home-Based Exercise ...

The research team tested people's mobility, balance, ability to walk, and grip strength at the same time. What were the limits of the study?

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physicaltherapy.utoronto.ca

physicaltherapy.utoronto.ca/time-home-and-after-feasibility-study

TIME at Home: A Before-and-After Feasibility Study

We are evaluating the safety and feasibility of a hybrid, group-based, 8-week, virtual, task-oriented community exercise program called TIME TM at Home.