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

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. 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 data supports the effectiveness of the treatment TIME™ at Home for limited mobility?

Research shows that home-based exercise programs can improve physical functioning in older adults with chronic illnesses and mobility restrictions. These programs are feasible and can be effectively delivered through cooperation between healthcare providers and exercise therapists. ^{1 2 3 4 5}

Is the TIME™ at Home exercise program safe for people with limited mobility?

Research shows that home-based exercise programs, like TIME™ at Home, are generally safe for older adults, even those with limited mobility or chronic health conditions, as long as they are supervised and participants have medical clearance. Some studies report adverse events, but these are often minor and can be managed with proper guidance and supervision. ^{6 7 8 9 10}

How is the TIME™ at Home treatment different from other treatments for limited mobility?

The TIME™ at Home treatment is unique because it is a home-based exercise program specifically designed for individuals with limited mobility, allowing them to participate without needing to visit a gym or clinic. It involves collaboration between general practitioners and exercise therapists to ensure the program is tailored and accessible for those who are chronically ill or have mobility restrictions. ^{2 3 11 12 13}

What is the purpose of this trial?

The goal of this randomized controlled trial is to compare the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) with a waitlist control in community-dwelling adults with balance and mobility limitations. The main questions the trial aims to answer are: 1. Will there be improvements in physical and mental health outcomes, and caregiver mood and assistance, following participation in the TIME™ at Home exercise program that are greater than in the waitlist control group? 2. Will level of mobility limitation, sex, or gender influence the experiences of people in the exercise program? 3. What will be the costs of the TIME™ at Home exercise program for the organization delivering the program, and the people who are in the exercise program? Participants and their caregivers will be asked to complete 3 evaluations using Zoom at study entry and 2 and 5 months later. * Participants will complete tests of balance and walking and questionnaires. * Caregivers will only complete questionnaires. After the first evaluation, participants will be randomly assigned to either participate in: * the 8-week TIME™ at Home exercise program from their homes using Zoom, or * to wait 5 months (waitlist control group) before beginning the 8-week TIME™ at Home exercise program

Research Team

Nancy Salbach, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

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

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

I live on my own or in an assisted living setting.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Home exercise program compliance of service members in the deployed environment: an observational cohort study. [2022]

2. England 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. [2023]

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

Alternatives for cardiac rehabilitation patients unable to return to a hospital-based program. [2007]

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

Effects of a home-based exercise program on clinical outcomes in heart failure. [2007]

5. England 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. [2022]

6. United States 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. [2015]

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

High-intensity home health physical therapy among older adult Veterans: A randomized controlled trial. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Translating Behavior Change Principles Into a Blended Exercise Intervention for Older Adults: Design Study. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Exploring participants' perspectives on adverse events due to resistance training: a qualitative study. [2023]

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

Home-Based Indoor Physical Activity Programs for Community-Dwelling Older Adults: A Systematic Review. [2023]

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

Home-Based Pulmonary Rehabilitation for Subjects With COPD: A Randomized Study. [2022]

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

Design and implementation of a home-based exercise program post-hip fracture: the Baltimore hip studies experience. [2021]