Technology-based Body and Mind Intervention for Fall Prevention in Older Adults

Overseen By Ladda Thiamwong, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Central Florida

Disqualifiers: Uncontrolled cardiac disease, Rehabilitation, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new exercise program designed to help older adults improve balance and reduce fall risk. The program, called PEER (Physio-feedback Exercise Program), combines group exercises and home-based activities to align perceived fall risks with actual physical risks. Participants will either join the PEER exercise group or receive fall prevention information to compare outcomes. This trial may suit those aged 60 and older who live independently and feel at risk of falling but do not have severe health issues preventing exercise. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance fall prevention strategies for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technology-based intervention is safe for older adults?

Research has shown that the Physio-fEedback Exercise pRogram (PEER) is safe for older adults. In previous studies, participants in the PEER program did not experience any falls and attended 87.5% of the sessions, indicating the program's positive reception. The PEER program includes physio-feedback (technology that helps track physical progress), cognitive reframing (changing how one thinks about falling), and guided exercises. These components help improve balance and reduce the risk of falls without causing harm.

For the peer-led exercises, studies have shown these programs effectively teach fall prevention and increase physical activity levels. After eight weeks of peer-led training, participants significantly increased their physical activity. These programs are generally considered safe and beneficial, emphasizing group support and involvement.

Overall, both parts of the study show no significant safety concerns and offer promising benefits for reducing fall risks in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a fresh approach to preventing falls in older adults through a unique combination of technology and peer support. Unlike typical fall prevention strategies that often rely on simple balance and strength exercises, this trial incorporates physio-feedback, which provides participants with personalized insights into their balance and risks. Additionally, the trial emphasizes peer-led exercises, fostering a supportive community that can help motivate participants. This approach not only targets physical aspects but also integrates cognitive reframing, encouraging participants to set personal goals and develop action plans. Overall, this trial aims to uncover whether this holistic and technology-enhanced method can effectively reduce falls and improve the quality of life for older adults.

What evidence suggests that this trial's interventions could be effective for fall prevention in older adults?

Research has shown that the Physio-Feedback Exercise Program (PEER), which participants in this trial may receive, can greatly improve balance and lower the risk of falls in older adults. In earlier studies, participants in the PEER program spent more time being active and less time sitting. They attended 87.5% of the sessions and did not experience any falls during the program. Additionally, peer-led exercises, another component of this trial, have been proven to help older adults maintain and improve their strength and balance. These findings suggest that both the PEER program and peer-led exercises can enhance physical abilities and increase awareness of fall risks in older adults. ^{1 2 6 7 8}

Who Is on the Research Team?

Ladda Thiamwong, PhD, RN

Principal Investigator

University of Central Florida

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 60 or older, living independently without severe cognitive impairment (MIS score ≥ 5). It's not suitable for those in rehab or with uncontrolled heart conditions that limit exercise.

Inclusion Criteria

No marked cognitive impairment (Memory Impairment Screen (MIS) score ≥ 5)

I am 60 years old or older.

Understand English

Exclusion Criteria

I cannot exercise due to a heart condition that causes symptoms like shortness of breath or chest pain during physical activity.

I am currently in a rehabilitation program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments and are randomized into either the PEER intervention or attention control group

1 week

Treatment

Participants in the PEER group engage in group and home-based exercises focusing on balance and strength training for 8 weeks. The AC group receives educational materials on fall prevention.

8 weeks

Weekly group sessions and home exercises

Follow-up

Participants are monitored for changes in balance, fall risk, and physical activity at 3 and 6 months post-treatment

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• CDC older adults fall prevention
• Cognitive reframing
• Peer-led exercises
• Physio-feedback

Trial Overview The study tests a home-based exercise program called PEER aimed at preventing falls by improving balance and aligning perceived fall risk with actual physical risk. Participants will either do group and home exercises or receive CDC fall prevention information.

How Is the Trial Designed?

Group I: Physio-fEedback Exercise pRogram (PEER) Group Experimental Treatment 3 Interventions

In week 1 participants will receive the first technology-based physio-feedback, cognitive reframing based on the fall risk appraisal matrix and develop a personal goal setting and action plan. From week 1 to week 8, participants will receive tailored exercise training. Participants will perform peer-led exercises (60 mins/week) and individual exercise at home for at least 30 minutes twice per week. Exercise training consists of four sets of exercise: a) warm-up (seated); b) strength upper and lower body (seated and standing); c) balance (standing and moving); and d) stretch lower and upper body. Participants will receive an exercise booklet (English or Spanish version) with illustrations that highlight steps for each set of exercise and provide a wide variety of exercises to integrate into daily activity such as cooking. Finally, in week 8, participants will receive the second physio-feedback and printed BTracks Balance System (BBS) results.

Group II: Attention Control (AC) Group Experimental Treatment 1 Intervention

Participants in the AC group will receive an information pamphlet about falls, Simple Exercises for Improving Balance and Preventing Falls in Older Adults, (English or Spanish version) that was developed by the CDC Stopping Elderly Accidents, Deaths, and Injuries (STEADI)-Older Adult Fall Prevention. The topics contain information on fall risk, how to prevent falls, check for safety, postural hypotension and chair rise exercise included what you can do to prevent falls, check for safety, postural hypotension, and chair rise exercise. The control group will be encouraged to discuss fall prevention with a primary care provider and continue normal activities (treatment-as-usual) for 6 months. Participants will be offered the PEER intervention when the study concludes.

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The study aims to test the feasibility of a peer-led physical activity intervention for older adults from socio-economically disadvantaged backgrounds, using a randomized controlled trial design over 12 weeks with follow-up at 6 months.

Data collected will assess recruitment, retention, and the effectiveness of the intervention in increasing moderate to vigorous physical activity, which is crucial for informing a larger definitive trial if the pilot proves successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walk with Me: a protocol for a pilot RCT of a peer-led walking programme to increase physical activity in inactive older adults. Tully, MA., Cunningham, C., Cupples, ME., et al.[2022]

The PEER intervention, involving visual feedback, cognitive reframing, and exercise, effectively shifted fall risk perceptions in 11% of older adults, while the control group showed no positive shifts and a higher rate of negative shifts (32%).

Participants in the PEER group experienced significant reductions in fall risk and reported high acceptability of the program, suggesting that such interventions can enhance both safety and exercise adherence among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shifting Maladaptive Fall Risk Appraisal in Older Adults through an in-Home Physio-fEedback and Exercise pRogram (PEER): A Pilot Study. Thiamwong, L., Huang, HJ., Ng, BP., et al.[2021]

Linking a peer coach physical activity intervention to primary care resulted in only 5.7% participation from referred patients, but 66.7% of those who participated continued for a year, indicating strong retention among engaged individuals.

The study found that the number needed to refer to achieve one long-term participant in the program was 26.5, suggesting that this approach could be a feasible method to promote long-term physical activity in older adults with relatively low referral effort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking a peer coach physical activity intervention for older adults to a primary care referral scheme. van de Vijver, PL., Schalkwijk, FH., Numans, ME., et al.[2023]

Older adults (average age 76) found self-managing their fall prevention exercise programs, whether through a digital platform or a paper booklet, to be empowering and flexible, allowing them to tailor their routines to their personal needs.

Participants using the digital program reported a stronger sense of support and motivation, which may enhance their long-term adherence to exercise, suggesting that digital tools could improve the effectiveness of self-managed fall prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Managing pieces of a personal puzzle' - Older people's experiences of self-management falls prevention exercise guided by a digital program or a booklet. Pettersson, B., Wiklund, M., Janols, R., et al.[2020]

A study involving 24 older adults (ages 70 to 97) using the SureStep program for 4 months revealed that older adults are receptive to technology-based exercise programs for fall prevention, highlighting the importance of making these programs enjoyable and motivating to enhance adherence.

Key factors influencing adherence included the perceived benefits of the program, its stimulating nature, and the ease of use, suggesting that future technology-based exercise programs should focus on these aspects to improve usability and long-term participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Interactive Home-Based Cognitive-Motor Step Training Program to Reduce Fall Risk in Older Adults: Qualitative Descriptive Study of Older Adults' Experiences and Requirements. Valenzuela, T., Razee, H., Schoene, D., et al.[2020]

The 8-week PEER program, involving 19 older adults with a mean age of 76, significantly improved dynamic balance, handgrip strength, and reduced fall risk, demonstrating its efficacy in enhancing physical capabilities.

The intervention was feasible and safe, with an 87.5% attendance rate and no reported falls, indicating that the combination of physio-feedback, cognitive reframing, and peer coaching effectively motivated older adults to engage in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physio-Feedback and Exercise Program (PEER) Improves Balance, Muscle Strength, and Fall Risk in Older Adults. Thiamwong, L., Stout, JR., Sole, ML., et al.[2021]

A 12-week peer-led exercise program significantly improved physical function in adults aged 50 and above, with notable enhancements in tests like the chair stand and 6-minute walk test.

Participants in the intervention group also reported lower stress levels and better perceived health, indicating psychosocial benefits, although there were no significant changes in metabolic health compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-led exercise program for ageing adults to improve physical functions - a randomized trial. Bouchard, DR., Olthuis, JV., Bouffard-Levasseur, V., et al.[2021]

The PEER (Physio-Feedback Exercise Program) is an innovative 8-week intervention designed for low-income older adults, combining technology-based feedback, cognitive reframing, and peer-led exercises to improve balance and reduce fall risk.

This study aims to assess the effectiveness of the PEER program on fall risk and self-perception in 340 participants, highlighting its potential to address health disparities and enhance motivation in fall prevention among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing a Technology-Based Body and Mind Intervention to Prevent Falls and Reduce Health Disparities in Low-Income Populations: Protocol for a Clustered Randomized Controlled Trial. Thiamwong, L., Xie, R., Park, JH., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228488/

Than Just Exercise: Older Adults' Experience of the Peer-Led ... This study aimed to explore older adults' experiences and perceptions regarding participation in a newly developed 8-week peer-led group-based exercise program ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12342789/

Educated peers' experiences and perceptions of the group ... Peer-led exercise programmes have demonstrated effectiveness in delivering fall prevention education to older adults.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999311003352

Evaluation of a Peer-Led Falls Prevention Program for ... These peer-led classes adapted from the Otago Exercise Program were more effective for maintaining and improving strength and balance in older adults with ...

4. eurapa.biomedcentral.com eurapa.biomedcentral.com/articles/10.1186/s11556-021-00257-x

Peer-led exercise program for ageing adults to improve ... The current work suggests that a 12-week peer-led exercise program can improve physical function for adults age 50 and above.

5. researchgate.net researchgate.net/publication/393280802_More_Than_Just_Exercise_Older_Adults'_Experience_of_the_Peer-Led_Group-Based_FallFitness_Program

(PDF) More Than Just Exercise: Older Adults' Experience ... Results After 8 weeks of peer-led training, the short multicomponent exercise program significantly improved the physical activity levels (p = ...

6. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05575-0

FallFitness exercise program provided using the train-the ... Results. After 8 weeks of peer-led training, the short multicomponent exercise program significantly improved the physical activity levels (p = ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999314000884

Long-Term Participation in Peer-Led Fall Prevention ... The SAYGO programme is a 1 h weekly group exercise programme run by a trained facilitator for 10 weeks. The SAYGO exercises were adapted from the home-delivered ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2735075

Effect of a Home-Based Exercise Program on Subsequent ... A home-based strength and balance retraining exercise program significantly reduced subsequent falls compared with usual care only (1.4 vs 2.1 falls per person ...