Falls Prevention Program for At-Risk Adults

Overseen By Gabriel Somarriba, PT, DPT, EdD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of St. Augustine for Health Sciences

Must not be taking: Anti-coagulants

Disqualifiers: Inability to kneel, No clearance, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a Falls Prevention Program designed to improve balance and mobility in adults at risk of falling. Participants will engage in activities such as obstacle course training and walking exercises to determine if these can reduce falls and related injuries. Individuals who have experienced a fall in the past five years or have mobility difficulties might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance fall prevention strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking prescription anti-coagulants, you need physician clearance to participate.

What prior data suggests that this Falls Prevention Program is safe for at-risk adults?

Research shows that falls prevention programs are generally safe for participants. Studies have found that these programs can boost confidence and reduce the fear of falling, helping people feel more stable and less worried. Additionally, clinical trials have demonstrated that these programs significantly lower the number of falls compared to those who do not participate.

Participants typically engage in exercises and activities designed to improve balance and ease movement. These activities are well-tolerated and have not been associated with serious side effects. Overall, falls prevention programs are considered safe and effective for adults at risk of falling. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Falls Prevention Program because it takes a comprehensive and proactive approach to reducing fall risk among at-risk adults. Unlike standard treatments that might focus on isolated exercises or medication, this program combines obstacle course training with falls strategies, plus walking and balance exercises, all in one package. This dual-session approach not only targets physical balance but also equips participants with strategic skills to handle potential falls, offering a more holistic and engaging method of prevention.

What evidence suggests that this Falls Prevention Program is effective for reducing fall risk in at-risk adults?

Studies have shown that programs to prevent falls can greatly reduce the number of falls among older adults living at home. Research indicates that these programs not only decrease falls but also reduce the fear of falling, which boosts confidence and improves quality of life. Evidence-based programs like FallsTalk have proven to lower fall rates compared to those who do not participate in any program. The CDC provides guidelines that enhance the effectiveness of these programs by focusing on balance, strength, and safe movement techniques. These findings suggest that joining a falls prevention program, such as the Falls Prevention Program tested in this trial, can improve mobility and reduce injuries from falls. ^{4 6 7 8 9}

Who Is on the Research Team?

Miguel Garcia, PT, DPT, EdD

Principal Investigator

University of St. Augustine for Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-100 who are at risk of falling, can attend sessions twice a week for five weeks, and have medical clearance to participate. They should be able to perform basic mobility tasks like getting up from a chair in less than 45 seconds. People on anti-coagulants without doctor's approval or those unable to kneel or sit on the floor aren't eligible.

Inclusion Criteria

I am either male or female.

I am at risk for falls, based on my history or test results.

Exclusion Criteria

I am not cleared by a doctor to join a falls prevention program.

Other reasons that may limit participation in intervention

I cannot kneel, sit on the floor, and get back up without help.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Falls Prevention Training

Participants complete 10 sessions of falls prevention training, including obstacle course training, falls strategies, and walking and balance exercises.

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in postural assessment, fall risk, and balance confidence from baseline to 1-year post intervention.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Falls Prevention Program

Trial Overview The study tests a Falls Prevention Program aimed at improving functional mobility and reducing fall risks and injuries. Participants will undergo assessments, obstacle course training, strategies training, as well as walking and balance exercises.

How Is the Trial Designed?

Group I: Falls Prevention training Experimental Treatment 1 Intervention

The intervention consists of 10 sessions. One session a week consists of obstacle course training. The other session consists of falls strategies and walking and balance exercises. Each session lasts approximately 1.5 hours

Falls Prevention Program is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Falls Prevention Program for:

• Prevention of falls and fall-related injuries in adults at risk

Approved in European Union as Community-Based Falls Prevention Program for:

• Reduction of falls risk in older adults
• Improvement of functional mobility in adults at risk for falls

Approved in Canada as Falls Prevention Intervention for:

• Prevention of falls in community-dwelling older adults
• Reduction of fall-related injuries

Who Is Running the Clinical Trial?

University of St. Augustine for Health Sciences

Lead Sponsor

Trials

8

Recruited

450+

Published Research Related to This Trial

In a study involving 369 older adults at high risk of falling, community-based fall assessments had higher attendance rates compared to hospital-based assessments, indicating better accessibility for participants.

However, there was no significant difference in the total number of falls between the two groups after 12 months, suggesting that community-based assessments may not be more effective than traditional hospital-based assessments in preventing falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based fall assessment compared with hospital-based assessment in community-dwelling older people over 65 at high risk of falling: a randomized study. Suman, S., Myint, PK., Clark, A., et al.[2019]

The Stay In Balance program (SIB) was developed through a collaborative effort involving professionals, local service providers, and older adults, and was tested with 135 participants to create an effective fall prevention strategy.

The program's development process highlighted the importance of ongoing adjustments based on feedback from each phase, emphasizing that successful implementation of fall prevention programs requires long-term commitment and adequate funding from all partners involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a community-based fall prevention program: Stay In Balance. Williams, HG., Ullmann, G.[2021]

Falls and injuries are a significant patient safety issue across various care settings, and this review highlights the need for effective prevention strategies in both community and healthcare environments.

Promising prevention methods identified include targeted risk evaluation in emergency departments and managing vitamin D deficiency, but more research is needed on staffing ratios and automated risk assessment methods to enhance fall prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fall and injury prevention. Currie, LM.[2007]

A study involving 454 older adults (average age 77.9) at 13 outpatient falls clinics in Victoria, Australia, revealed that 78% had experienced falls in the previous 6 months, highlighting a significant risk of falls in this population.

After implementing multifactorial interventions, there was over a 50% reduction in falls and fall-related injuries after 6 months, along with improvements in balance, leg strength, and gait speed, indicating the effectiveness of falls clinic programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of falls clinics: an evaluation of outcomes and client adherence to recommended interventions. Hill, KD., Moore, KJ., Dorevitch, MI., et al.[2019]

Unintentional falls are the leading cause of injuries in Americans aged 65 and older, highlighting the urgent need for effective fall prevention strategies as the population ages.

The article proposes a conceptual model for local health departments and community organizations to implement evidence-based fall prevention programs, aiming to reduce the significant health care burden associated with falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Local Service Delivery to Prevent Falls in Community-Dwelling Older Adults: Translating Research to Practice. Gagen, TM., Bulzacchelli, MT.[2021]

A fall prevention program using a nurse advice telephone line was implemented for older adults at a Veterans Affairs healthcare facility, but it faced challenges in sustainability due to staffing limitations and competing priorities, leading to its discontinuation after 18 months.

While the project showed initial feasibility and improved home safety counseling for patients, significant barriers such as transportation issues hindered follow-up care, highlighting the need for strong leadership and resource commitment for future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formative evaluation of the telecare fall prevention project for older veterans. Miake-Lye, IM., Amulis, A., Saliba, D., et al.[2021]

Multifactorial fall prevention programs are more effective for older adults with a history of falls compared to those without such a history, highlighting the importance of tailored interventions.

Exercise programs that include muscle strengthening, balance, and endurance training for at least 12 weeks are effective in reducing falls among community-dwelling older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on falls prevention for community-dwelling older adults: review of single and multifactorial intervention programs. Costello, E., Edelstein, JE.[2009]

A survey of primary care providers revealed that while 87% believe fall risk assessments can effectively reduce falls in older adults, only 52% feel qualified to conduct these assessments.

Despite a strong belief in the importance of fall risk assessment, awareness of established fall prevention programs like the CDC's STEADI Toolkit and Matter of Balance is very low among providers, indicating a gap in knowledge that needs to be addressed for better integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older adult fall prevention practices among primary care providers at accountable care organizations: A pilot study. Howland, J., Hackman, H., Taylor, A., et al.[2023]

Fall hazards identification programs did not show a significant difference in reducing the incidence of falls compared to control groups in a review of 8 studies involving 5177 participants, with an incidence rate ratio of 0.98.

Despite the lack of significant findings, the study suggests potential benefits of these programs, indicating a need for larger, more rigorous studies to better assess their effectiveness in preventing falls among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Fall Hazards Identification on Fall Outcomes: A Systematic Review With Meta-analysis. Ziebart, C., Bobos, P., Furtado, R., et al.[2022]

The Four Smart Steps Fall Prevention program, which includes exercise, eye exams, home safety, and primary care visits, was designed to improve fall prevention awareness among community-dwelling older adults.

Implementing this program at a senior center led to increased safety awareness and knowledge about fall risks, potentially helping older adults maintain their independence in a safer living environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four Smart Steps: Fall Prevention for Community-Dwelling Older Adults. Minnier, W., Leggett, M., Persaud, I., et al.[2019]

Community-based organizations are crucial in educating older adults about fall prevention, but they face challenges in adopting and sustaining evidence-based programs due to staffing and funding limitations.

Effective marketing to center directors is essential for the widespread adoption of fall prevention programs, as they need to consider sustainability options for these health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging community-based organizations in fall prevention education. Kramer, BJ., Vivrette, RL., Rubenstein, LZ.[2016]

The review identified key risk factors for falls in non-ambulatory adults, including wheelchair-related issues, transfer activities, impaired seated balance, and environmental factors, highlighting the need for clinicians to understand these risks to better support their clients.

There is a lack of comprehensive outcome measures and structured fall prevention programs specifically for non-ambulatory adults, indicating a significant gap in research and the need for further studies to develop effective management protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of risk factors associated with accidental falls, outcome measures and interventions to manage fall risk in non-ambulatory adults. Rice, LA., Ousley, C., Sosnoff, JJ.[2022]

A study of 249 senior centers across 10 US academic centers found that 35% of these centers did not offer any evidence-based community fall prevention programs (EBCFPPs), highlighting a significant gap in available resources for fall prevention among seniors.

Among the centers that did offer EBCFPPs, Tai Chi was the most common program available (59.8%), while other programs like 'A Matter of Balance' and 'Stepping On' were much less frequently offered, indicating limited diversity in fall prevention options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Community Fall Prevention Programs at Senior Centers Near 10 US Academic Centers. Hamel, C., Hekmatjah, N., Hakakian, B., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11590344/

Falls prevention interventions for community-dwelling older ... We included studies with at least one intervention aiming to prevent falls in community-dwelling older adults and delivered in, or referable ...

2. cdc.gov cdc.gov/falls/interventions/community-prevention.html

Community Prevention | Older Adult Fall Prevention This guide provides organizations with the building blocks of effective fall prevention programs by providing examples, resources, and tips.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10924894/

Evaluation of a Fall Prevention Program to Reduce ... The client-centered SAH program demonstrates significant reductions in falls, fear of falling, and high satisfaction among clients.

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2819573

Interventions to Prevent Falls in Community-Dwelling Older ... In 2018, 27.5% of community-dwelling adults 65 years or older reported at least 1 fall in the past year and 10.2% reported a fall-related injury ...

5. ncoa.org ncoa.org/article/evidence-based-falls-prevention-programs/

Evidence-Based Falls Prevention Programs for Older Adults Clinical trials and community results provide evidence that FallsTalk significantly reduces falls compared to untreated fallers. FallScape.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9432804/

Effects of Nurse-Led Fall Prevention Programs for Older Adults A combination of the outcomes of this review: fall rates, fall injury, and behavior change could maximize the effects of fall prevention program outcomes.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK560761/

Falls and Fall Prevention in Older Adults - StatPearls - NCBI Falls are the most common type of accidents in people 65 years of age and older, and are the major cause of hospitalization related to injury in this age group.

8. acl.gov acl.gov/programs/health-wellness/falls-prevention-program

Falls Prevention Program Studies have shown that participation in evidence-based falls prevention programs can improve confidence, decrease fear of falling, and result ...

9. cdc.gov cdc.gov/falls/data-research/facts-stats/index.html

Facts About Falls | Older Adult Fall Prevention Falls can cause broken bones, like wrist, arm, ankle, and hip fractures.6 · Falls can cause head injuries. These can be very serious, especially ...