Exercise Program for Frailty

Overseen By Guy Hajj Boutros

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must not be taking: Antidepressants, Antipsychotics, others

Disqualifiers: Heart disease, Dementia, Drug abuse, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on prescribed medication that may interfere with the study results, you might need to stop or adjust them.

What data supports the effectiveness of the SAFE Exercise Program treatment for frailty?

Research shows that exercise programs, especially those that include multiple types of exercises like endurance, strength, balance, and flexibility, can help improve the health and physical abilities of frail older adults. Programs that last at least five months and are done three times a week for 30-45 minutes tend to have the best results. ^{1 2 3 4 5}

Is the Exercise Program for Frailty safe for humans?

Research shows that exercise programs for frail older adults, including those using interactive video games, are generally safe and can improve health and physical function. In one study, safety compliance with the physical activity exceeded 87%, and the exercise was found to be safe and beneficial for heart health. ^{1 6 7 8 9}

How is the SAFE Exercise Program different from other treatments for frailty?

The SAFE Exercise Program is unique because it combines endurance, strength, balance, and flexibility exercises specifically designed to improve physical frailty in older adults. Unlike other treatments, it emphasizes a comprehensive approach to enhance resilience and reduce the risk of adverse health outcomes. ^{2 5 6 10 11}

Research Team

Jose Morais, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

This trial is for older adults who are frail or pre-frail, meaning they're at risk of falls due to muscle weakness (sarcopenia) and general decline in physical ability as they age. Participants should be able to follow a video-based exercise program.

Inclusion Criteria

Considered Frail or Pre frail according to Fried's criteria

Exclusion Criteria

I have a disorder affecting my balance or inner ear.

I have a kidney problem.

Mental illness diagnosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Pre-intervention Assessment

Assessment of cognition and functional abilities and explanation of the exercise program

1 visit

1 visit (in-person)

Treatment

Participants in the experimental group engage in the SAFE exercises three times a week for 12 weeks at home

12 weeks

1 visit (virtual)

Post-intervention Assessment

Post-intervention assessment of cognition and functional abilities

1 visit

1 visit (in-person)

Follow-up

Participants are monitored by telephone to follow up whether they are still following the SAFE program or not

12 weeks

1 visit (virtual)

Treatment Details

Interventions

• SAFE program

Trial Overview The SAFE exercise program is being tested to see if it can prevent falls in frail and pre-frail older adults. Half the participants will do these exercises while the other half won't, with a check-in after 12 weeks post-intervention.

Participant Groups

Group I: SAFE program Experimental Treatment 1 Intervention

Participants will be asked to carry out the SAFE program with the help of a caregiver. Our healthcare professionals will visit them during the first week to explain to them and their caregivers how to perform the exercises correctly while using our website. All exercises will be performed using video capsules available on our website (https://safe-seniors.com/fr). The exercises are divided into 4 levels of difficulty: level 1 (light); level 2 (moderate); level 3 (moderate to vigorous); and level 4 (vigorous). Each level lasts 25 to 30 minutes and includes 5 exercise categories split into 5 videos: warm-up, strength, balance, flexibility, and endurance. The exercise intervention will include 3 sessions per week over 12 weeks.

Group II: Control group Active Control 1 Intervention

Participants will be asked to continue their activities of daily living without making any changes.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Findings from Research

Exercise interventions have a positive effect on physical determinants and functional abilities in frail older adults, based on a systematic review of 47 randomized controlled trials.

Multicomponent training programs lasting at least 5 months, with sessions three times a week for 30-45 minutes, showed the best outcomes for managing frailty compared to other exercise types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise interventions for the management of frailty: a systematic review. Theou, O., Stathokostas, L., Roland, KP., et al.[2022]

The HOPE programme, a 12-week home-based exercise intervention for older adults with frailty, showed a non-significant trend towards improved mobility, suggesting potential benefits for this population.

In a pilot study with 84 participants, the intervention group demonstrated a mean adjusted improvement in mobility (measured by the timed-up-and-go test) compared to the control group, indicating that exercise may help mitigate mobility decline in frail older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Home-based Older People's Exercise (HOPE) trial: a pilot randomised controlled trial of a home-based exercise intervention for older people with frailty. Clegg, A., Barber, S., Young, J., et al.[2022]

A 6-week supervised exercise program combining power training and high-intensity interval training (HIIT) significantly improved frailty status in 64% of older adults, with an average improvement of 1.6 points on the Frailty Phenotype scale.

Participants in the exercise group also showed notable enhancements in physical performance, including a 47% increase in muscle power and a 19% improvement in aerobic capacity, while the control group experienced no significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a short multicomponent exercise intervention focused on muscle power in frail and pre frail elderly: A pilot trial. Losa-Reyna, J., Baltasar-Fernandez, I., Alcazar, J., et al.[2019]

In a study involving 300 older adults (average age 82.5 years) with signs of frailty, it was found that greater severity of frailty is linked to lower functional independence and health-related quality of life (HRQoL).

The participants were randomized into a 12-month home-based exercise program or usual care, highlighting the potential for supervised physical activity to improve outcomes for frail individuals, although the results of the intervention are not detailed in this abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older persons with signs of frailty in a home-based physical exercise intervention: baseline characteristics of an RCT. Suikkanen, S., Soukkio, P., Pitkälä, K., et al.[2022]

A 16-week multicomponent exercise program significantly improved physical frailty in older adults, with 46% of pre-frail and 50% of frail participants becoming more robust after the intervention.

The exercise program was particularly effective for frail and pre-frail individuals, leading to a notable reduction in frailty scores, while robust individuals showed a slight increase in frailty, highlighting the program's targeted benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Multicomponent Exercise Program on Prevalence and Severity of the Frailty Syndrome in a Sample of Italian Community-Dwelling Older Adults. Mulasso, A., Roppolo, M., Rainoldi, A., et al.[2023]

The group-based Otago exercise program (OEP) was successfully implemented with 18 older adults with cognitive impairment, showing significant improvements in frailty scores after three months of participation.

Participants demonstrated enhanced physical function, as evidenced by significant improvements in the Time Up and Go test, 30 seconds Sit-To-Stand Test, and Four-Stage Balance Test, indicating that OEP is an effective intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of the group-based Otago exercise program on frailty among nursing home older adults with cognitive impairment. Feng, H., Zou, Z., Zhang, Q., et al.[2021]

The HOPE trial is a pilot randomized controlled trial involving a 12-week home-based exercise program aimed at improving mobility and functional abilities in frail older adults, with the primary outcome measured by the timed-up-and-go test (TUGT).

This study is notable for using a validated method to assess frailty at baseline, which may enhance the reliability of the results compared to previous trials that used non-validated measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial. Clegg, A., Barber, S., Young, J., et al.[2021]

After 6 weeks of using the FRED exergame, only 5% of elderly participants showed signs of frailty, compared to 100% in the control group, indicating a significant reduction in frailty risk (p < 0.001).

Participants using the FRED exergame also reported improved independence in daily activities and a better perception of their health, with a safety compliance rate exceeding 87%, demonstrating that this exercise method is both effective and safe for elderly individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty Level Monitoring and Analysis after a Pilot Six-Week Randomized Controlled Clinical Trial Using the FRED Exergame Including Biofeedback Supervision in an Elderly Day Care Centre. Mugueta-Aguinaga, I., Garcia-Zapirain, B.[2020]

In a study of 31 frail older women participating in a 12-week exercise program, both home-based and center-based programs effectively reversed frailty in 76% of participants, demonstrating significant improvements in muscle strength and physical function.

The home-based program showed high adherence rates, while the center-based program was more effective in reversing frailty status, indicating that both approaches can be beneficial for frail older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Home-Based Exercise Improve the Physical Function of Prefrail Older Women? Garcia, RNSA., Costa, SN., Garcia, EDSA., et al.[2021]

Exercise is the most effective therapy to reverse frailty in older adults, with recommendations for pre-frail individuals to engage in 2-3 sessions per week of 45-60 minutes, focusing on aerobic, resistance, flexibility, and balance training.

Frail older adults should exercise 3 times a week for 30-45 minutes, primarily emphasizing aerobic training, with intensity levels set to a 'somewhat hard' effort on the Borg CR10 scale to maximize functional improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise prescription to reverse frailty. Bray, NW., Smart, RR., Jakobi, JM., et al.[2022]

The PROMUFRA multicomponent frailty program, involving strength and myofascial exercises over 20 weeks, significantly improved physical frailty status and various muscle function parameters in 81 older adults compared to a control group.

Participants in the intervention group also showed positive changes in body composition, including increased muscle mass and improved range of motion, along with a trend towards reduced pain, highlighting the program's potential benefits for frail and pre-frail individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty Status Improvement after 5-Month Multicomponent Program PROMUFRA in Community-Dwelling Older People: A Randomized Controlled Trial. Barrachina-Igual, J., Pablos, A., Pérez-Ros, P., et al.[2022]

References

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

The effectiveness of exercise interventions for the management of frailty: a systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The Home-based Older People's Exercise (HOPE) trial: a pilot randomised controlled trial of a home-based exercise intervention for older people with frailty. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effect of a short multicomponent exercise intervention focused on muscle power in frail and pre frail elderly: A pilot trial. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Older persons with signs of frailty in a home-based physical exercise intervention: baseline characteristics of an RCT. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Multicomponent Exercise Program on Prevalence and Severity of the Frailty Syndrome in a Sample of Italian Community-Dwelling Older Adults. [2023]

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

The effect of the group-based Otago exercise program on frailty among nursing home older adults with cognitive impairment. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Frailty Level Monitoring and Analysis after a Pilot Six-Week Randomized Controlled Clinical Trial Using the FRED Exergame Including Biofeedback Supervision in an Elderly Day Care Centre. [2020]

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

Does Home-Based Exercise Improve the Physical Function of Prefrail Older Women? [2021]

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

Exercise prescription to reverse frailty. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Frailty Status Improvement after 5-Month Multicomponent Program PROMUFRA in Community-Dwelling Older People: A Randomized Controlled Trial. [2022]