Frailty Rehabilitation for Older Adults with Frailty

Overseen By Sherri Smith

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Protein supplements

Disqualifiers: Cognitive impairment, Palliative care, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

324 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific rehabilitation program can help older adults with frailty improve their physical abilities and reduce healthcare needs. The trial will test three approaches: no intervention with just Vitamin D, group exercise (Walk With Ease Program), and a combination of exercise, nutrition, and medication review. It seeks participants aged 65 and older who live in the community, can walk at least 25 meters, have a high risk of mobility issues, and have received medical clearance. Participants must be able to visit the YMCA twice a week and provide proof of COVID-19 vaccination.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for older adults.

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 prior data suggests that this frailty rehabilitation program is safe for older adults?

Research has shown that group exercise programs like Walk With Ease are generally easy for older adults to join. This program includes walking, stretching, and strengthening exercises, which can enhance physical abilities without major safety concerns. Most participants manage it well, with few reports of serious side effects.

Regarding social activities, studies suggest that increased social activity can help reduce the risk of frailty in older adults. Increasing social participation is considered safe and beneficial, often leading to better physical and mental health.

Previous research indicates that both exercise and social activities are safe. These components are expected to be manageable and beneficial for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for frailty in older adults because they focus on holistic approaches that go beyond standard care. Traditional treatments for frailty often include medication and nutritional supplementation, but these new methods emphasize the power of exercise and social interaction. The group exercise program aims to improve physical resilience through twice-weekly sessions, while the multi-modal intervention combines exercise with nutrition, protein supplementation, and medication review, offering a comprehensive plan for boosting overall health. These innovative approaches may not only enhance physical strength but also improve mental well-being, addressing both the body and mind.

What evidence suggests that this trial's treatments could be effective for frailty?

Research has shown that group exercise, one of the treatments in this trial, can enhance physical abilities and reduce pain and fatigue in older adults. Participants in the Group Exercise arm will join programs like Walk With Ease, which include walking, stretching, and strengthening exercises, to boost confidence and increase time spent on self-care activities. Another treatment arm focuses on socialization, where engaging in community activities can help reverse frailty in older adults. Social activity can improve physical and mental health by reducing loneliness and slowing memory decline. Together, these activities aim to enhance overall well-being and lower health risks associated with frailty. ^{2 3 5 6 7}

Who Is on the Research Team?

Alexandra Papaioannou, MD, MSc

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Group Exercise
• Socialization

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.

How Is the Trial Designed?

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.

Group Exercise is already approved in United States for the following indications:

Approved in United States as Walk With Ease for:

• Arthritis management
• Fall prevention
• Chronic disease management

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

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 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]

A life goal-setting technique (LGST) combined with a standard preventive care program significantly improved health outcomes in frail older adults, with a 60% improvement on the Kihon Checklist compared to a 40% improvement in the control group over 9 months.

The intervention group also showed significant improvements in quality of life at 3 months, indicating that LGST is a promising addition to exercise programs for reducing frailty and the risk of needing care.

NCBI (Pubmed)

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. Yuri, Y., Takabatake, S., Nishikawa, T., 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]

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]

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]

The healthy ageing intervention program significantly improved health, social function, and mental well-being among frail older adults, as reported by participants before and after the program.

Despite the positive outcomes for those who completed the program, a high drop-out rate due to health issues and transportation difficulties indicates a need for more flexible options in community-based programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a healthy ageing intervention for frail older people living in the community. McNamara, B., Rosenwax, L., Lee, EA., et al.[2019]

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]

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]

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]

Both group and self-directed formats of the Arthritis Foundation's Walk With Ease program led to significant increases in walking duration, with participants averaging around 34 minutes of walking at the 1-year follow-up.

While both formats showed similar self-reported walking outcomes, group participants were more likely to engage in recommended stretching and warm-up/cool-down exercises, suggesting that group settings may enhance adherence to comprehensive exercise guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achievement of exercise objectives and satisfaction with the walk with ease program-group and self-directed participants. Nyrop, KA., Cleveland, R., Callahan, LF.[2016]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2695175/

Effectiveness of two Arthritis Foundation programs: Walk ... The WWE resulted in increased confidence, physical abilities, time spent in self-management activities and decreased pain and fatigue.

2. archpublichealth.biomedcentral.com archpublichealth.biomedcentral.com/articles/10.1186/s13690-023-01219-8

An observational pilot evaluation of the Walk with Ease ... This pilot study evaluates outcomes of a community delivered WWE program for potential suitability as a fall risk reduction program.

3. trials.arthritis.org trials.arthritis.org/trials/NCT05693025

Evaluation of the Walk With Ease Program for Fall Prevention The study will evaluate the effectiveness of incorporating physical therapy exercises (primary prevention strategy) within an established physical activity ...

4. ncoa.org ncoa.org/article/evidence-based-program-walk-with-ease/

Evidence-Based Program: Walk With Ease Developed by the Arthritis Foundation, this program focuses on three key components: walking, stretching, and strengthening exercises.

5. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.20490

Evaluation of group and self‐directed formats of the Arthritis ... Walk With Ease (WWE), a 6-week community-based walking group program for adults with arthritis, was developed ∼10 years ago by the Arthritis ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10662528/

An observational pilot evaluation of the Walk with Ease ... This pilot study evaluates outcomes of a community delivered WWE program for potential suitability as a fall risk reduction program.

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-20138-z

Study protocol: process and outcome evaluation of the Walk ... Overview of Walk with Ease. The WWE intervention is a 6-week group exercise program designed to build functional capacity in older adults.