Walk With Ease + Physical Therapy for Fall Prevention

Overseen By Gregory J. Welk, Ph.D.

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Iowa State University

Disqualifiers: Active lifestyle, Not at fall risk

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

Compensation: Varies

Number of Visits: 24

Duration: 6 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding personalized physical therapy exercises to a walking program can help reduce falls in older adults. Participants will join group exercise sessions and use an online portal with tips, goals, and habit-training lessons (behavioral training). The trial will compare different exercise and training methods to identify the most effective approach. It seeks individuals aged 65 or older who can stand for at least 10 minutes without pain and are not very active or prone to falls. As a Phase 1/Phase 2 trial, this research focuses on understanding the treatment's mechanism and measuring its effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Walk With Ease program, created by the Arthritis Foundation, is safe and easy to manage. It includes walking, stretching, and strengthening exercises, which are generally low-risk activities. In past studies, participants improved in physical function and daily activities, indicating the program's safety for older adults.

For the program's behavior-learning component, studies have shown that exercise programs can help reduce falls and improve balance and strength. These exercises are usually safe when done with guidance, such as with a physical therapist or coach in this trial.

Since this trial is in the early stages, researchers are still evaluating the treatment's safety. However, existing evidence from similar programs suggests a low risk of side effects for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these fall prevention methods because they offer a personalized and comprehensive approach to reducing fall risks in older adults. The Enhanced Implementation model is unique with its tailored exercises prescribed by licensed physical therapists, aiming to specifically address individual needs and enhance physical function. Meanwhile, the Enhanced Training model stands out by leveraging technology, providing participants with an online portal for goal setting, habit-formation training, and motivational support, all designed to sustain engagement in physical activity. These methods could complement or even improve upon standard exercise programs by adding personalized care and digital support, potentially leading to better outcomes in fall prevention.

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

Research shows that the Walk with Ease program, which includes walking, stretching, and strengthening exercises, helps older adults move better and fall less often. In this trial, participants in the Enhanced Implementation (EI) and Standard Implementation (SI) arms will complete the Walk with Ease group exercise program. Studies have found that walking may be more effective than balance training for preventing falls in people at low risk. The program's exercises improve balance, strength, and mobility, reducing falls and injuries from falls. Participants in the Enhanced Training (ET) and Standard Training (ST) arms will receive behavioral training, which involves forming habits around these exercises. This approach can boost motivation and make it easier to stick with the program, further lowering the risk of falls. Together, these elements make the Walk with Ease program a promising way to prevent falls in older adults. ^{1 2 4 6 7}

Who Is on the Research Team?

Candis M. Hunter, Ph.D.

Principal Investigator

National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC)

Are You a Good Fit for This Trial?

This trial is for older adults, specifically those aged 65 or above who can stand for at least 10 minutes without pain and have their doctor's permission. It's not suitable for people who aren't at risk of falls or are already somewhat active with daily physical activity.

Inclusion Criteria

I am 65 years old or older.

I can stand for at least 10 minutes without feeling pain.

Written permission from a physician

Exclusion Criteria

Already somewhat active (defined as at least 15 minutes of physical activity per day)

I am not at risk for falling.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 6-week structured Walk with Ease group exercise program, with sessions held 3 days a week for an hour each session, including warmup, walking, and cool-down exercises.

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for changes in fall risk, physical activity, and other health outcomes.

12 months

Periodic assessments at 6 weeks, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Training
• Group Exercise

Trial Overview

The study tests the 'Walk With Ease' program, which combines physical therapy exercises with behavioral training to prevent falls in older adults. Participants will be randomly assigned to receive either individually prescribed exercises or standardized ones.

How Is the Trial Designed?

Group I: Enhanced Training (ET) Experimental Treatment 1 Intervention

Participants the Enhanced Training (ET) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide habit-formation training about how to form regular habits for physical activity. Participants are paired with a student 'coach' trained in motivational interviewing skills to provide virtual assistance in maintaining motivation during the programming.

Group II: Enhanced Implementation (EI) Experimental Treatment 1 Intervention

Participants the Enhanced Implementation (SI) model complete the 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete personalized exercises prescribed by a licensed Physical Therapist to help reduce potential risks of falling.

Group III: Standard Implementation (SI) Active Control 1 Intervention

Participants the Standard Implementation (SI) model complete a 6 week structured Walk with Ease group exercise program designed to build capacity and function in older adults. Sessions are held 3 days a week for an hour each session. Each session includes a 10 minute warmup including strength/flexibility exercises, a 30 minute bout of walking and a 10 minute cool-down including strength/flexibility exercises. Participants complete standard exercises recommended in the base program.

Group IV: Standard Training (ST) Active Control 1 Intervention

Participants the Standard Training (ST) model receive access to on online portal with weekly tips and education content, goal setting options and a daily tracking system for logging walking and exercises performed. They receive instruction on how to use the portal and are encouraged to use the integrated eBook and resources to supplement the group exercise programming. Weekly video-based lessons provide standard knowledge-based training about how to become more physically active.

Who Is Running the Clinical Trial?

Iowa State University

Lead Sponsor

Trials

63

Recruited

145,000+

Published Research Related to This Trial

Exercise is beneficial for stroke prevention as it positively influences risk factors like hypertension, diabetes, and obesity, although definitive large-scale trials are still needed to confirm these effects.

Post-stroke exercise is influenced by various factors, including self-efficacy and social support, and effective strategies to promote exercise include physician endorsement and structured programming, especially for older patients or those with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for stroke prevention. Prior, PL., Suskin, N.[2022]

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 Arthritis Foundation's Walk With Ease program, an evidence-based intervention for osteoarthritis, can be effectively integrated into physical therapy education and practice, enhancing treatment options for older adults.

This delivery model is cost-effective and sustainable, benefiting not only patients with osteoarthritis but also health profession students and community organizations involved in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responding to stakeholder needs to engage rehabilitation professionals in the delivery of evidence-based health programming for adults with osteoarthritis. Chevan, J., Barrett, M., Nowakowski, K., et al.[2022]

The revised 6-week Walk With Ease (WWE) program significantly improved self-reported outcomes and performance measures in adults with arthritis, showing benefits in disability, pain, fatigue, and strength, with no reported adverse events.

Both instructor-led and self-directed formats of the WWE program were effective, with self-directed participants maintaining more significant improvements in certain outcomes at the 1-year mark, highlighting the program's safety and accessibility for promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of group and self-directed formats of the Arthritis Foundation's Walk With Ease Program. Callahan, LF., Shreffler, JH., Altpeter, M., et al.[2011]

Nordic walking (NW) training over 15 sessions in 3 individuals with Parkinson's disease led to significant improvements in gait speed, walking distance, and motor symptoms, with participants showing retained benefits after 3 months.

Participants experienced a notable reduction in freezing episodes and falls, indicating that NW not only enhances physical function but may also improve safety and quality of life for those with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nordic walking training in persons with Parkinson's disease: Individualized prescription-A case series. Harro, CC., Horak, I., Valley, K., et al.[2023]

A progressive exercise program focusing on moderate to high-intensity balance exercises is highly effective in preventing falls among community-dwelling older adults, emphasizing the importance of tailored physical therapy interventions.

For older adults in institutional settings, combining exercise programs with multifactorial interventions shows promise in fall prevention, with a minimum of 50 hours of exercise recommended to significantly reduce fall risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based exercise prescription for balance and falls prevention: a current review of the literature. Shubert, TE.[2022]

A novel fall prevention intervention combining physical therapy exercises with Dance Movement Therapy (DMT) was explored in a study involving 11 older adults, revealing important emotional experiences during balance-focused exercises.

The study identified key emotional themes such as self-image, social relationships, and past memories, suggesting that addressing emotional aspects can enhance the effectiveness of fall prevention strategies for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the emotional content of older adults engaging in a fall prevention exercise program integrated with dance movement therapy: a preliminary study. Pitluk Barash, M., Elboim-Gabyzon, M., Shuper Engelhard, E.[2023]

The Minnesota Arthritis Training Program (MATP) was developed to empower patients with arthritis by teaching them self-management skills to handle symptoms, modify exercise, and manage medication side effects effectively.

The program also addresses psychological issues related to rheumatoid arthritis, helping patients improve their social support systems and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Minnesota Arthritis Training Program: emphasis on self-management, not compliance. Mahowald, ML., Steveken, ME., Young, M., et al.[2019]

The 8-week intervention combining exercise, exposure therapy, and cognitive restructuring significantly reduced fear of falling and activity avoidance in 42 older adults, with effect sizes indicating strong improvements (d = 1.23 for fear and d = 1.02 for activity avoidance).

The intervention was safe, as it did not increase the number of falls among participants, but the benefits diminished over a 6-month follow-up, suggesting that adjustments may be necessary to sustain the positive effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Exposure Therapy and Exercise Reduces Fear of Falling and Avoidance in Older Adults: A Randomized Pilot Study. Wetherell, JL., Bower, ES., Johnson, K., et al.[2019]

A survey of 444 physical therapists and physical therapist assistants revealed that about 40% conduct community-based fall screenings, primarily those with over 20 years of experience, indicating a strong engagement in fall prevention efforts.

Most therapists are familiar with the CDC's STEADI toolkit, and approximately 75% of those conducting screenings refer older adults to evidence-based programs, highlighting the importance of PTs and PTAs in promoting fall prevention resources in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapists as Partners for Community Fall Risk Screenings and Referrals to Community Programs. Vincenzo, JL., Hergott, C., Schrodt, L., et al.[2023]

Long-term compliance with health-promoting behaviors, such as weight reduction and exercise, is low among both healthy individuals and patients with coronary heart disease, highlighting significant barriers to adherence.

To improve compliance in exercise training and other health programs, especially in cardiac rehabilitation, physical therapists need to adopt innovative and creative strategies that address behavioral and socioeconomic challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term compliance. Ice, R.[2022]

Packaged self-management education and exercise programs for arthritis have been shown to effectively reduce long-term pain and disability, helping individuals maximize their abilities and manage their conditions better.

Despite their benefits, these programs are underutilized, as many public health professionals are not aware of them, highlighting the need for greater awareness and evaluation of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention programs for arthritis and other rheumatic diseases. Brady, TJ., Kruger, J., Helmick, CG., et al.[2022]

A community-based program integrating joyful movement for fall prevention engaged 215 older adults and showed significant improvements in functional balance and confidence, as evidenced by the Functional Reach Test and Modified Falls Efficacy Scale.

Participants reported increased optimism (70%) and better walking ability (50%), indicating that the program not only improved physical outcomes but also positively affected participants' mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Community-Based Program That Integrates Joyful Movement Into Fall Prevention for Older Adults. Carlucci, C., Kardachi, J., Bradley, SM., et al.[2020]

The Walk with Ease (WWE) program significantly increased self-reported physical activity among older adults, with notable improvements in moderate-to-vigorous physical activity levels (d = 0.56, p = 0.004).

While the program did not show significant improvements in physical function or overall fall risk reduction, participants identified as at higher risk for falls exhibited larger effect sizes, indicating potential benefits for this group and suggesting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observational pilot evaluation of the Walk with Ease program for reducing fall risk among older adults. Lamoureux, NR., Lansing, J., Welk, GJ.[2023]

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