Frailty Rehabilitation for Older Adults with Frailty

Recruiting in Palo Alto (17 mi)

Overseen by Alexandra Papaioannou, MD, MSc

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: McMaster University

Must not be taking: Protein supplements

Disqualifiers: Cognitive impairment, Palliative care, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Frailty is an important clinical state that contributes to falls, hospitalization, institutionalization and death. When an individual simultaneously has many health problems, a frailty "tipping point" may be triggered by even a minor stressful event such as adding a new drug or urinary tract infection. Our research suggests that approximately 23% of Canadians over age 65 are frail, and by age 85 this estimate increases to over 40%. As we learn more about frailty and its consequences, there is an urgent need to develop community-based interventions that will prevent or delay frailty in older adults. Our proposed study will examine if frailty rehabilitation program is an effective community-based intervention to promote healthy aging. The primary objective of our study is to determine if 4-month frailty rehabilitation improves physical function compared with control and exercise alone in community-dwelling older adults living with frailty and sarcopenia. Secondary objectives of our study are to determine if 4-months of frailty rehabilitation can improve functional abilities and reduce healthcare utilization during a 6-month follow-up period compared with control and exercise alone. Results will translate the first Canadian model of frailty and sarcopenia rehabilitation and management.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently in a drug optimization study or program, you would not be eligible to participate.

What data supports the effectiveness of the treatment for frailty rehabilitation in older adults?

Research shows that group exercise programs like the Otago exercise program can significantly reduce frailty in older adults, and the Walk With Ease program has been effective in achieving exercise goals and satisfaction among participants. Additionally, social activities and community engagement have been linked to improvements in frailty, suggesting that combining physical and social interventions can be beneficial. ^{1 2 3 4 5}

Is the frailty rehabilitation program safe for older adults?

The frailty rehabilitation programs, including high-intensity walking and exercise combined with nutrition education, have been shown to be safe for older adults, with no reported adverse events in the studies. Participants found these programs satisfactory and beneficial for improving physical function. ^{4 6 7 8 9}

How is the 'Walk With Ease Program' treatment different from other treatments for frailty in older adults?

The 'Walk With Ease Program' is unique because it combines group exercise with social interaction and community engagement, which has been found to be more effective than home-based exercise for improving frailty. This approach not only focuses on physical activity but also emphasizes socialization, which can enhance motivation and adherence to the program. ^{10 11 12 13 14}

Research Team

Alexandra Papaioannou, MD, MSc

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for community-dwelling adults over 65 who can walk 25m with/without aid, have medical clearance, and can get to the YMCA twice a week. They must be fully vaccinated against COVID-19 and at high risk for mobility issues but not in palliative care or other specific health programs.

Inclusion Criteria

I can get to the YMCA twice a week.

I am at high risk for having trouble moving around or doing daily tasks.

Proof of being fully vaccinated against COVID-19 and proof of identification

Exclusion Criteria

You are currently participating in a group exercise program.

I have unstable chest pain or heart failure.

You are currently participating in a medication optimization program.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-month frailty rehabilitation program, including group exercise, supplemental home exercise, nutrition, protein supplementation, and medication review.

4 months

Follow-up

Participants are monitored for functional abilities and healthcare utilization during a 6-month follow-up period.

6 months

Treatment Details

Interventions

• Control (Other)
• Group Exercise (Behavioural Intervention)
• Socialization (Behavioural Intervention)

Trial Overview The study tests if a 4-month frailty rehabilitation program improves physical function in older adults with frailty and sarcopenia compared to control groups receiving only exercise or no intervention. It includes nutrition, medication review, vitamin D supplements, group exercises, and protein supplements.

Participant Groups

Group I: Arm3.Multi-modal Intervention Experimental Treatment 4 Interventions

Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented.

Group II: Arm2.Group Exercise Experimental Treatment 2 Interventions

Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.

Group III: Arm1.Control Experimental Treatment 2 Interventions

Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Evan Stein

McMaster University

Chief Medical Officer since 2015

MD, PhD

Sam

McMaster University

Chief Executive Officer since 2023

MBA from McMaster University

Findings from Research

A study involving 146 older adults with frailty or pre-frailty showed that both supervised and home-based exercise programs significantly improved walking speed and muscle strength after 3 months.

Participants in the supervised exercise group experienced greater improvements in physical performance tests compared to those in the home-based group, highlighting the benefits of professional supervision in exercise programs for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of concurrent aerobic and resistance exercise in frail and pre-frail older adults: A randomized trial of supervised versus home-based programs. Meng, NH., Li, CI., Liu, CS., et al.[2022]

In frail older adults, increased participation in social activities significantly predicted improvement in frailty over 2 years, suggesting that social engagement is beneficial for this group.

For pre-frail older adults, improvements in frailty were linked to higher levels of physical activity and lower depressive symptoms, indicating that physical health and mental well-being are crucial for preventing further decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social factors predicting improvement of frailty in community-dwelling older adults: Korean Frailty and Aging Cohort Study. Jang, AR., Won, CW., Sagong, H., et al.[2021]

The MoveStrong program, an 8-week exercise and nutrition intervention delivered via telephone and virtual sessions, was feasible and well-accepted by older adults, with a high retention rate of 93% and adherence to sessions exceeding 80%.

Participants showed significant improvements in physical function, as evidenced by increased chair stand test scores and enhanced dietary protein intake, indicating the program's effectiveness in addressing frailty in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MoveStrong at home: a feasibility study of a model for remote delivery of functional strength and balance training combined with nutrition education for older pre-frail and frail adults. Wang, E., Keller, H., Mourtzakis, M., et al.[2022]

A 12-session high-intensity walking training (HIWT) program significantly reduced frailty and improved physical performance in five prefrail and frail older adults, with notable increases in gait speed and balance.

The intervention was safe, with no adverse events reported, and participants rated their satisfaction highly, indicating strong support for incorporating HIWT into routine care for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Impact of High-Intensity Walking Training in Frail Older Adults. Danilovich, MK., Conroy, DE., Hornby, TG.[2018]

The group-based Otago exercise program (OEP) significantly improved physical function, including mobility, balance, and lower limb strength, as well as reducing frailty and enhancing health status in older nursing home residents, based on a meta-analysis of 12 studies.

Shorter 30-minute exercise sessions were found to be more effective for improving balance compared to longer sessions, and training led by physiotherapists was particularly beneficial for enhancing mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a group-based Otago exercise program on physical function, frailty and health status in older nursing home residents: A systematic review and meta-analysis. Peng, Y., Yi, J., Zhang, Y., et al.[2023]

Researchers at the University of Manchester are developing a behavior change intervention aimed at pre-frail older adults to encourage participation in group-based physical activity classes, which have been shown to effectively slow the progression of frailty.

There is strong support from stakeholders for proactively addressing pre-frailty, as a significant number of older adults are affected, suggesting that such interventions could enhance healthy aging and improve overall health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of physical activity signposting for pre-frail older adults: a qualitative study to inform intervention development. Money, A., Harris, D., Hawley-Hague, H., et al.[2023]

Training interventions are the most effective way to improve health outcomes in frail older adults, according to several systematic reviews and meta-analyses.

Group exercise programs are more beneficial than home-based exercise for frail individuals, highlighting the need for expanded access to group training opportunities for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis of frailty as starting point for training interventions]. Benzinger, P., Rapp, K., Bauer, J.[2022]

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]

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]

References

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

Achievement of exercise objectives and satisfaction with the walk with ease program-group and self-directed participants. [2016]

2. Australia pubmed.ncbi.nlm.nih.gov

Evaluation of a healthy ageing intervention for frail older people living in the community. [2019]

3. 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]

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

Effects of concurrent aerobic and resistance exercise in frail and pre-frail older adults: A randomized trial of supervised versus home-based programs. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Social factors predicting improvement of frailty in community-dwelling older adults: Korean Frailty and Aging Cohort Study. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

MoveStrong at home: a feasibility study of a model for remote delivery of functional strength and balance training combined with nutrition education for older pre-frail and frail adults. [2022]

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

Feasibility and Impact of High-Intensity Walking Training in Frail Older Adults. [2018]

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

The effectiveness of a group-based Otago exercise program on physical function, frailty and health status in older nursing home residents: A systematic review and meta-analysis. [2023]

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

Acceptability of physical activity signposting for pre-frail older adults: a qualitative study to inform intervention development. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

[Diagnosis of frailty as starting point for training interventions]. [2022]

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

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

12. Canada pubmed.ncbi.nlm.nih.gov

Exercise prescription to reverse frailty. [2022]

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

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

14. England pubmed.ncbi.nlm.nih.gov

The effects of a life goal-setting technique in a preventive care program for frail community-dwelling older people: a cluster nonrandomized controlled trial. [2022]