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

Trial Summary

What is the purpose of this trial?

The goal of this interventional study is to implement a Falls Prevention Program to impact the risk and injuries related to falls. The main question is to learn and examine the effects of a falls prevention program on the functional mobility of adults at risk for falls. Participants will: * Complete functional mobility assessments * Complete Falls prevention obstacle course training * Complete Falls Strategies Training * Complete walking and balance training

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 data supports the effectiveness of the Falls Prevention Program treatment?

Research shows that community-based fall prevention programs can help reduce falls in older adults by identifying risks and providing appropriate interventions. These programs have been effective in some studies, although results can vary depending on how they are implemented. ^{1 2 3 4 5}

Is the Falls Prevention Program safe for humans?

The Falls Prevention Program, under various names, has been implemented in community settings and involves activities like exercise, eye exams, and home safety checks. These programs are generally safe and aim to increase safety awareness and knowledge among older adults, helping them live independently and safely. ^{5 6 7 8 9}

How is the Falls Prevention Program different from other treatments for preventing falls in older adults?

The Falls Prevention Program is unique because it is a community-based approach that combines multiple strategies, such as exercise, home hazard assessments, and health screenings, to address various risk factors for falls, making it more comprehensive than single-strategy treatments. ^{7 10 11 12 13}

Research Team

Miguel Garcia, PT, DPT, EdD

Principal Investigator

University of St. Augustine for Health Sciences

Eligibility Criteria

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 between 18 and 100 years old.

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.

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

I am on prescription blood thinners without approval from my doctor to join this trial.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England 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. [2022]

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

Effectiveness of falls clinics: an evaluation of outcomes and client adherence to recommended interventions. [2019]

3. Germany 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. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Formative evaluation of the telecare fall prevention project for older veterans. [2021]

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

The Efficacy of Fall Hazards Identification on Fall Outcomes: A Systematic Review With Meta-analysis. [2022]

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

Fall and injury prevention. [2007]

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

Development of a community-based fall prevention program: Stay In Balance. [2021]

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

Four Smart Steps: Fall Prevention for Community-Dwelling Older Adults. [2019]

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

Engaging community-based organizations in fall prevention education. [2016]

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

Evidence-Based Community Fall Prevention Programs at Senior Centers Near 10 US Academic Centers. [2020]

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

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

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

Older adult fall prevention practices among primary care providers at accountable care organizations: A pilot study. [2023]

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

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