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

Trial Summary

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 data supports the effectiveness of the treatment for fall prevention in older adults?

Research shows that the Physio-Feedback and Exercise Program (PEER) significantly improves balance, muscle strength, and reduces fall risk in older adults. Participants in the study experienced better dynamic balance and handgrip strength, with high attendance and no falls reported, indicating the treatment's effectiveness and safety. ^{1 2 3 4 5}

Is the Technology-based Body and Mind Intervention for Fall Prevention in Older Adults safe?

The Physio-Feedback and Exercise Program (PEER), which is part of this intervention, has been shown to be safe for older adults. In a study with 19 participants, there were no falls reported, and the program was well-received with high attendance. ^{1 2 3 4 6}

How is the Technology-based Body and Mind Intervention for Fall Prevention in Older Adults treatment different from other treatments?

This treatment is unique because it combines technology-based physio-feedback, cognitive reframing, and peer-led exercises to improve balance and strength, making it more engaging and potentially more effective than traditional exercise programs. It uses the BTrackS Balance Tracking System to provide real-time feedback and track progress, which can help older adults better understand and manage their fall risk. ^{1 3 5 7 8}

What is the purpose of this trial?

Older adults may feel at risk for falling, but do not have a physical risk of falling. On the other hand, some older adults may not feel at risk for falling, but do have a physical risk of falling. This study is being done to test a preventative, in-home exercise program (called PEER) which may allow older adults to improve balance, align the perceived risk for falling with the physical risk for falling, and prevent falls. Participants will be asked to participate in this study for approximately 9 months. This study has three specific aims: 1. Examine differences in balance, fall risk, and physical activity after program completion, follow-up 3 months and 6 months between older adults (OAs) in the Physio-fEedback Exercise pRogram (PEER) intervention and OAs in attention control (AC) condition. 2. Explore differences in exercise adherence and the proportion of shifting in fall risk appraisal and negative self-perception on aging after program completion, follow-up 3 months and 6 months between OAs in the PEER intervention and OAs in AC condition. 3. Explore participants' experiences with the PEER intervention and potential barriers to access and adoption of the technology-based PEER intervention to inform future research. Participants will be asked to participate in this study for approximately 9 months. This includes the baseline assessment, 8 weeks of PEER activities or attention control activities, and follow-up assessments at 3 months and 6 months. After the informed consent and completion of the baseline assessments, participants will be randomized to either the PEER intervention or the attention control (AC) group. Participants in the PEER intervention group will be asked to participate in group exercises (60 minutes per week for 8 weeks) and home-based exercises (twice a week for 8 weeks) that focus on balance, strength training with a peer coach. Participants in the AC group will receive an information pamphlet developed by the CDC about falls called Simple Exercises for Improving Balance and Preventing Falls in Older Adults. Topics include information on fall risks, how to prevent falls, how to check for safety, postural hypotension, and chair rise exercises. The control group will be encouraged to discuss fall prevention with a primary care provider and continue normal activities.

Research Team

Ladda Thiamwong, PhD, RN

Principal Investigator

University of Central Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

Physio-Feedback and Exercise Program (PEER) Improves Balance, Muscle Strength, and Fall Risk in Older Adults. [2021]

2. United States 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. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Peer-led exercise program for ageing adults to improve physical functions - a randomized trial. [2021]

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

Linking a peer coach physical activity intervention for older adults to a primary care referral scheme. [2023]

5. Canada 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. [2023]

6. England 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. [2022]

7. England 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. [2020]

8. Canada 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. [2020]