FallNCT05778604
Optimizing a Technology-based Body and Mind Intervention
A study testing Physio-feedback, Cognitive reframing and Peer-led exercises in people with Fall and Fear of Falling, run by University of Central Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Fear of Falling, Physical Inactivity
- What is being tested?
- Physio-feedback, Cognitive reframing and Peer-led exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 60 years of age,
- No marked cognitive impairment [Memory Impairment Screen (MIS) score ≥ 5]
- Live in their own homes or senior/retirement units
- Understand English
Who cannot join
- A medical condition precluding exercise such as uncontrolled cardiac disease (shortness of breath or feel pressure, squeezing, burning, or tightness when doing a physical activity)
- Currently receiving treatment from a rehabilitation facility
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Central Florida
Orlando, Florida, 32816
Ladda Thiamwong, PhD, RN, 407-823-0470, Ladda.Thiamwong@ucf.edu
Ladda Thiamwong, PhD, RN
About this study
Official title: Optimizing a Technology-based Body and Mind Intervention to Prevent Falls and Reduce Health Disparities in Low-income Populations
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:
- 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.
- 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.
- 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.
- Conditions
- Fall, Fear of Falling, Physical Inactivity, Sedentary Behavior
- Being tested
- Physio-feedback, Cognitive reframing, Peer-led exercises, CDC older adults fall prevention
- Keywords
- Maladaptive Fall Risk Appraisal (FRA), Fear of Falling, Older Adults, Exercise, Accidental Falls, Risk Assessment, Technology, Wearable devices
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physio-feedbackBehavioural
The researcher presents the BTrackS software to display the participant's BBS score (s) with interpretations including: (1) baseline, post-baseline, percent of changes; (2) comparison to sex and age group; and (3) levels of fall risk. The researcher will categorize participants into four groups (irrational | incongruent | congruent | rational) based on the fall risk appraisal (FRA) matrix and plots the position on one of the four quadrants in the FRA matrix chart. The researcher will provide physio-feedback to participants at baseline and week 9.
Cognitive reframingBehavioural
Cognitive reframing will be based on the fall risk appraisal (FRA) matrix. We will present the FRA matrix and activities will be tailored based on the quadrant that participant fits. Quadrant 1 (Irrational) focus on increasing balance confidence and maintaining exercise. Quadrant 2 (Incongruent) focus on individual fall risk factors from the CDC fall risk checklist, enhance fall risk awareness, and participate in the exercise. Quadrant 3 (Congruent) focus on individual fall risk factors from the CDC fall checklist and participate in the exercise. Quadrant 4 (Rational) encourage to maintain exercise.
Peer-led exercisesBehavioural
The peer-led exercise is focused on balance, strength training, and incorporating exercises into daily activities. A trained peer coach (PC) will lead the group-based exercises for 60 mins (8-10/group). Exercise training consists of four sets: a) warm-up (seated), b) strength for upper and lower body (seated and standing), c) balance (standing and moving), and d) stretching of the lower and upper body. We will provide an exercise booklet (English/Spanish version) with illustrations that highlight steps for each set of exercises and a wide variety of exercises to integrate into daily activities (e.g., cooking). Participants will be instructed to complete a weekly exercise log to record types and duration of activity performed at home.
CDC older adults fall preventionBehavioural
Participants will receive an information pamphlet about falls (English or Spanish version) developed by the CDC (Stopping Elderly Accidents, Deaths, and Injuries (STEADI)-Older Adult Fall Prevention). The pamphlet contains information on fall risk, how to prevent falls, check for safety, postural hypotension and chair rise exercise including what you can do to prevent falls. The participants will be encouraged to discuss fall prevention with a primary care provider and continue normal activities (treatment-as-usual) for 6 months. Participants will receive monthly follow-up phone calls from the study team to record a monthly fall incidence log.
| Study group | Role | What they receive |
|---|---|---|
| Physio-fEedback Exercise pRogram (PEER) Group | Experimental | 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. Receives: Behavioral: Physio-feedback; Behavioral: Cognitive reframing; Behavioral: Peer-led exercises |
| Attention Control (AC) Group | Experimental | 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. Receives: Behavioral: CDC older adults fall prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Fall Risk Reduction
Fall risk will be assessed by the CDC's STEADI fall risk checklist. It consists of 12 statements related to physical and psychological fall risk factors with yes or no answers. A score of 4 points or higher indicates a risk of falling. The sensitivity of this checklist with discriminating fallers and predicting future fallers for community-dwelling older adults 73-80 percent.
Measured: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Change from Baseline in Dynamic Balance as Measured By Timed-Up and Go (TUG) test
The dynamic balance will be assessed by the timed-up and go (TUG) tests. The TUG test has been widely used to assess functional mobility and predict fall risk and has been reported reliable data and validated among low-income older adults (LOA). Participants will stand up from a standard arm chair, walk at a normal pace for 3 meters, return, and sit down again. Participants who complete the TUG test in less than 12 seconds will be classified as having low fall risk.
Measured: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Change from Baseline in Dynamic Balance as Measured By Sit-to-Stand test
The dynamic balance will be assessed by the sit to stand tests. The CDC's STEADI Program suggests for the sit to stand test, participants will sit in the middle of a chair, place hands on the opposite shoulder crossed at the wrists, keep feet flat on the floor with back straight and arms against the chest, then repeat stand and sit back down motions for 30 second. The results will be scored based on age and gender.
Measured: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Change from Baseline in Physical Activity
Physical Activity (PA) will be measured by activity monitoring devices. All participants will wear the ActiGraph GT9X Link wireless activity monitor (ActiGraph LLC.), a tri-axial accelerometer, on the non-dominant wrist for 7 consecutive days. A sensor determines whether the device is on or off the wrist. The GT9X Link provides objective 24-hour physical activity measures including steps, energy expenditure, intensity, and participant's position. Accelerometry is a reliable method of assessing free-living physical activity (ICC=0.98) and has been validated against direct observation, energy expenditure, and sedentary behavior. The device display screen can be disabled so the device does not display the participant's activity (it will show date and time only).
Measured: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Secondary outcomes (2)
Change from Baseline in Fall Risk Appraisal Shifting
Fall risk appraisal (FRA) shifting consists of: (a) maladaptive shifting is moving from the rational quadrant into any other quadrant, and (b) adaptive shifting is moving from irrational, incongruent, or congruent into the rational quadrant. We use the fall risk appraisal matrix, a graphical grid categorizing levels of Fear of Falling (FOF) and levels of balance: (1) rational: low FOF (short FES-I ≤10) and normal balance (BBS ≤30); 2) incongruent: low FOF (short FES-I ≤10) despite poor balance (BBS>30); 3) irrational: high FOF (short FES-I >10) despite normal balance (BBS ≤30), and 4) congruent: high FOF (short FES-I >10) and poor balance (BBS>30).
Levels of balance will be measured by the BTrackS Balance System test (BBS). Participants will stand as still as possible on the balance plate with hands on hips and eyes closed for 3 mins. BBS scores range from 1 through 100.
Level of fear of falling (FOF) will be measured by a short Fall-Efficacy Scale International (FES-I).
Measured: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Change from Baseline in Negative Self-perceptions of Aging
Negative self-perceptions will be measured by the Brief Ageing Perceptions Questionnaire (B-APQ) which consists of 17 items. In the proposed study, we will calculate an overall negative perception score (range 17-85) by summing all negative scales after reverse scoring positive subscales. In our pilot study (N=48), this measure's Cronbach's alpha=0.64.
Measured: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start12 Apr 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will employ an intention-to-treat, single- blinded, parallel, two-arm clustered randomized controlled trial (RCT).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Ladda Thiamwong, University of Central Florida
- Investigators
- Ladda Thiamwong, PhD, RN, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778604
- Sponsor's protocol ID
- STUDY00003260
- Other IDs
- R01MD018025
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thiamwong L, Stout JR, Park JH, Yan X. Technology-Based Fall Risk Assessments for Older Adults in Low-Income Settings: Protocol for a Cross-sectional Study. JMIR Res Protoc. 2021 Apr 7;10(4):e27381. doi: 10.2196/27381.
PubMed 33825688Thiamwong L. Older Adults' Experiences With the Visual Physio-Feedback Technology and Peer-Led Combined Group and Home-Based Exercises. J Aging Phys Act. 2021 Aug 1;29(4):604-611. doi: 10.1123/japa.2019-0422. Epub 2020 Dec 30.
PubMed 33378743Thiamwong L, Stout JR, Sole ML, Ng BP, Yan X, Talbert S. Physio-Feedback and Exercise Program (PEER) Improves Balance, Muscle Strength, and Fall Risk in Older Adults. Res Gerontol Nurs. 2020 Nov 1;13(6):289-296. doi: 10.3928/19404921-20200324-01. Epub 2020 Apr 14.
PubMed 32286669Thiamwong L, Sole ML, Ng BP, Welch GF, Huang HJ, Stout JR. Assessing Fall Risk Appraisal Through Combined Physiological and Perceived Fall Risk Measures Using Innovative Technology. J Gerontol Nurs. 2020 Apr 1;46(4):41-47. doi: 10.3928/00989134-20200302-01.
PubMed 32219456Thiamwong L, Huang HJ, Ng BP, Yan X, Sole ML, Stout JR, Talbert S. Shifting Maladaptive Fall Risk Appraisal in Older Adults through an in-Home Physio-fEedback and Exercise pRogram (PEER): A Pilot Study. Clin Gerontol. 2020 Jul-Sep;43(4):378-390. doi: 10.1080/07317115.2019.1692120. Epub 2019 Nov 12.
PubMed 31713464Lafontant K, Fukuda DH, Marcano Maldonado P, Suarez JRM, Banarjee C, Leinbach CS, Fretti SK, Stout JR, Xie R, Thiamwong L. Effect of a Physio-Feedback-Based Exercise Intervention on Physical Function and Body Composition Among Low-Income Community-Dwelling Older Adults: A Cluster Randomized Controlled Trial. J Aging Phys Act. 2026 Oct 7:1-10. doi: 10.1123/japa.2025-0453. Online ahead of print.
PubMed 42849527Banarjee C, Lafontant K, Suarez JR, Lipat A, Parikh M, Lopez J, Leinbach C, Xie R, Thiamwong L. Evaluation of a Technology-Based Multifactorial Intervention for Improving Fall Risk: A Cluster-Randomized Controlled Trial. Res Sq [Preprint]. 2026 Jul 30:rs.3.rs-10412360. doi: 10.21203/rs.3.rs-10412360/v1.
PubMed 42620071Ali E, Lafontant K, Suarez JRM, Leinbach CS, Fukuda DH, Stout JR, Garcia-Retortillo S, Lopez J, Xie R, Thiamwong L. Using the Short Physical Performance Battery for Frailty Screenings Among Community-Dwelling Older Adults: An ROC Analysis. J Gerontol Geriatr. 2026 Jun;74(2):10. doi: 10.3390/jgg74020010. Epub 2026 Mar 31.
PubMed 42524156Banarjee C, Lafontant K, Suarez JR, Lopez J, Wang Z, Leinbach C, Xie R, Thiamwong L. Characterization of physical health variables across fall risk appraisal groups: a cross-sectional study. BMC Geriatr. 2026 Jul 18. doi: 10.1186/s12877-026-07745-8. Online ahead of print.
PubMed 42469669Suarez JRM, Decker VB, Park JH, Lighthall NR, Dino MJS, Thiamwong L. Directional postural sway tendencies and static balance among community-dwelling older adults with depression and without cognitive impairment. Aging Clin Exp Res. 2025 Aug 21;37(1):255. doi: 10.1007/s40520-025-03144-y.
PubMed 40839173Tice AL, Xie R, Zhang W, Conner NE, Li Y, Emrich CT, Huo Q, Thiamwong L. Associations of Frailty, Concerns About Falling, and Fall Risk in Community-Dwelling Older Adults in Orlando, Florida: A Preliminary Analysis. J Frailty Sarcopenia Falls. 2025 Mar 1;10(1):18-27. doi: 10.22540/JFSF-10-018. eCollection 2025 Mar.
PubMed 40035084Thiamwong L, Xie R, Park JH, Lighthall N, Loerzel V, Stout J. 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. JMIR Res Protoc. 2023 Oct 3;12:e51899. doi: 10.2196/51899.
PubMed 37788049
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Technology-based Body and Mind Intervention to Prevent Falls and Reduce Health Disparities in Low-income Populations
- ClinicalTrials.gov ID
- NCT05778604
- Acronym / sponsor ID
- STUDY00003260
- Conditions
- Fall, Fear of Falling, Physical Inactivity, Sedentary Behavior
- Keywords
- Maladaptive Fall Risk Appraisal (FRA), Fear of Falling, Older Adults, Exercise, Accidental Falls, Risk Assessment, Technology, Wearable devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will employ an intention-to-treat, single- blinded, parallel, two-arm clustered randomized controlled trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Physio-fEedback Exercise pRogram (PEER) Group | Experimental | Behavioral: Physio-feedback, Behavioral: Cognitive reframing, Behavioral: Peer-led exercisesIn 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. |
| Attention Control (AC) Group | Experimental | Behavioral: CDC older adults fall preventionParticipants 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 may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 60 years of age,
- No marked cognitive impairment [Memory Impairment Screen (MIS) score ≥ 5]
- Live in their own homes or senior/retirement units
- Understand English
Key exclusion criteria (2 listed)
- A medical condition precluding exercise such as uncontrolled cardiac disease (shortness of breath or feel pressure, squeezing, burning, or tightness when doing a physical activity)
- Currently receiving treatment from a rehabilitation facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physio-feedbackThe researcher presents the BTrackS software to display the participant's BBS score (s) with interpretations including: (1) baseline, post-baseline, percent of changes; (2) comparison to sex and age group; and (3) levels of fall risk. The researcher will categorize participants into four groups (irrational | incongruent | congruent | rational) based on the fall risk appraisal (FRA) matrix and plots the position on one of the four quadrants in the FRA matrix chart. The researcher will provide physio-feedback to participants at baseline and week 9. | Behavioural | Physio-fEedback Exercise pRogram (PEER) Group |
| Cognitive reframingCognitive reframing will be based on the fall risk appraisal (FRA) matrix. We will present the FRA matrix and activities will be tailored based on the quadrant that participant fits. Quadrant 1 (Irrational) focus on increasing balance confidence and maintaining exercise. Quadrant 2 (Incongruent) focus on individual fall risk factors from the CDC fall risk checklist, enhance fall risk awareness, and participate in the exercise. Quadrant 3 (Congruent) focus on individual fall risk factors from the CDC fall checklist and participate in the exercise. Quadrant 4 (Rational) encourage to maintain exercise. | Behavioural | Physio-fEedback Exercise pRogram (PEER) Group |
| Peer-led exercisesThe peer-led exercise is focused on balance, strength training, and incorporating exercises into daily activities. A trained peer coach (PC) will lead the group-based exercises for 60 mins (8-10/group). Exercise training consists of four sets: a) warm-up (seated), b) strength for upper and lower body (seated and standing), c) balance (standing and moving), and d) stretching of the lower and upper body. We will provide an exercise booklet (English/Spanish version) with illustrations that highlight steps for each set of exercises and a wide variety of exercises to integrate into daily activities (e.g., cooking). Participants will be instructed to complete a weekly exercise log to record types and duration of activity performed at home. | Behavioural | Physio-fEedback Exercise pRogram (PEER) Group |
| CDC older adults fall preventionParticipants will receive an information pamphlet about falls (English or Spanish version) developed by the CDC (Stopping Elderly Accidents, Deaths, and Injuries (STEADI)-Older Adult Fall Prevention). The pamphlet contains information on fall risk, how to prevent falls, check for safety, postural hypotension and chair rise exercise including what you can do to prevent falls. The participants will be encouraged to discuss fall prevention with a primary care provider and continue normal activities (treatment-as-usual) for 6 months. Participants will receive monthly follow-up phone calls from the study team to record a monthly fall incidence log. | Behavioural | Attention Control (AC) Group |
Primary outcome
Change from Baseline in Fall Risk Reduction
Time frame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Fall risk will be assessed by the CDC's STEADI fall risk checklist. It consists of 12 statements related to physical and psychological fall risk factors with yes or no answers. A score of 4 points or higher indicates a risk of falling. The sensitivity of this checklist with discriminating fallers and predicting future fallers for community-dwelling older adults 73-80 percent.
Change from Baseline in Dynamic Balance as Measured By Timed-Up and Go (TUG) test
Time frame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
The dynamic balance will be assessed by the timed-up and go (TUG) tests. The TUG test has been widely used to assess functional mobility and predict fall risk and has been reported reliable data and validated among low-income older adults (LOA). Participants will stand up from a standard arm chair, walk at a normal pace for 3 meters, return, and sit down again. Participants who complete the TUG test in less than 12 seconds will be classified as having low fall risk.
Change from Baseline in Dynamic Balance as Measured By Sit-to-Stand test
Time frame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
The dynamic balance will be assessed by the sit to stand tests. The CDC's STEADI Program suggests for the sit to stand test, participants will sit in the middle of a chair, place hands on the opposite shoulder crossed at the wrists, keep feet flat on the floor with back straight and arms against the chest, then repeat stand and sit back down motions for 30 second. The results will be scored based on age and gender.
Change from Baseline in Physical Activity
Time frame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Physical Activity (PA) will be measured by activity monitoring devices. All participants will wear the ActiGraph GT9X Link wireless activity monitor (ActiGraph LLC.), a tri-axial accelerometer, on the non-dominant wrist for 7 consecutive days. A sensor determines whether the device is on or off the wrist. The GT9X Link provides objective 24-hour physical activity measures including steps, energy expenditure, intensity, and participant's position. Accelerometry is a reliable method of assessing free-living physical activity (ICC=0.98) and has been validated against direct observation, energy expenditure, and sedentary behavior. The device display screen can be disabled so the device does not display the participant's activity (it will show date and time only).
2 secondary outcomes
Change from Baseline in Fall Risk Appraisal Shifting
Time frame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Change from Baseline in Negative Self-perceptions of Aging
Time frame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 33825688Thiamwong L, Stout JR, Park JH, Yan X. Technology-Based Fall Risk Assessments for Older Adults in Low-Income Settings: Protocol for a Cross-sectional Study. JMIR Res Protoc. 2021 Apr 7;10(4):e27381. doi: 10.2196/27381.
- Background: PubMed 33378743Thiamwong L. Older Adults' Experiences With the Visual Physio-Feedback Technology and Peer-Led Combined Group and Home-Based Exercises. J Aging Phys Act. 2021 Aug 1;29(4):604-611. doi: 10.1123/japa.2019-0422. Epub 2020 Dec 30.
- Background: PubMed 32286669Thiamwong L, Stout JR, Sole ML, Ng BP, Yan X, Talbert S. Physio-Feedback and Exercise Program (PEER) Improves Balance, Muscle Strength, and Fall Risk in Older Adults. Res Gerontol Nurs. 2020 Nov 1;13(6):289-296. doi: 10.3928/19404921-20200324-01. Epub 2020 Apr 14.
- Background: PubMed 32219456Thiamwong L, Sole ML, Ng BP, Welch GF, Huang HJ, Stout JR. Assessing Fall Risk Appraisal Through Combined Physiological and Perceived Fall Risk Measures Using Innovative Technology. J Gerontol Nurs. 2020 Apr 1;46(4):41-47. doi: 10.3928/00989134-20200302-01.
- Background: PubMed 31713464Thiamwong L, Huang HJ, Ng BP, Yan X, Sole ML, Stout JR, Talbert S. Shifting Maladaptive Fall Risk Appraisal in Older Adults through an in-Home Physio-fEedback and Exercise pRogram (PEER): A Pilot Study. Clin Gerontol. 2020 Jul-Sep;43(4):378-390. doi: 10.1080/07317115.2019.1692120. Epub 2019 Nov 12.
- Derived from this study: PubMed 42849527Lafontant K, Fukuda DH, Marcano Maldonado P, Suarez JRM, Banarjee C, Leinbach CS, Fretti SK, Stout JR, Xie R, Thiamwong L. Effect of a Physio-Feedback-Based Exercise Intervention on Physical Function and Body Composition Among Low-Income Community-Dwelling Older Adults: A Cluster Randomized Controlled Trial. J Aging Phys Act. 2026 Oct 7:1-10. doi: 10.1123/japa.2025-0453. Online ahead of print.
- Derived from this study: PubMed 42620071Banarjee C, Lafontant K, Suarez JR, Lipat A, Parikh M, Lopez J, Leinbach C, Xie R, Thiamwong L. Evaluation of a Technology-Based Multifactorial Intervention for Improving Fall Risk: A Cluster-Randomized Controlled Trial. Res Sq [Preprint]. 2026 Jul 30:rs.3.rs-10412360. doi: 10.21203/rs.3.rs-10412360/v1.
- Derived from this study: PubMed 42524156Ali E, Lafontant K, Suarez JRM, Leinbach CS, Fukuda DH, Stout JR, Garcia-Retortillo S, Lopez J, Xie R, Thiamwong L. Using the Short Physical Performance Battery for Frailty Screenings Among Community-Dwelling Older Adults: An ROC Analysis. J Gerontol Geriatr. 2026 Jun;74(2):10. doi: 10.3390/jgg74020010. Epub 2026 Mar 31.
- Derived from this study: PubMed 42469669Banarjee C, Lafontant K, Suarez JR, Lopez J, Wang Z, Leinbach C, Xie R, Thiamwong L. Characterization of physical health variables across fall risk appraisal groups: a cross-sectional study. BMC Geriatr. 2026 Jul 18. doi: 10.1186/s12877-026-07745-8. Online ahead of print.
- Derived from this study: PubMed 40839173Suarez JRM, Decker VB, Park JH, Lighthall NR, Dino MJS, Thiamwong L. Directional postural sway tendencies and static balance among community-dwelling older adults with depression and without cognitive impairment. Aging Clin Exp Res. 2025 Aug 21;37(1):255. doi: 10.1007/s40520-025-03144-y.
- Derived from this study: PubMed 40035084Tice AL, Xie R, Zhang W, Conner NE, Li Y, Emrich CT, Huo Q, Thiamwong L. Associations of Frailty, Concerns About Falling, and Fall Risk in Community-Dwelling Older Adults in Orlando, Florida: A Preliminary Analysis. J Frailty Sarcopenia Falls. 2025 Mar 1;10(1):18-27. doi: 10.22540/JFSF-10-018. eCollection 2025 Mar.
- Derived from this study: PubMed 37788049Thiamwong L, Xie R, Park JH, Lighthall N, Loerzel V, Stout J. 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. JMIR Res Protoc. 2023 Oct 3;12:e51899. doi: 10.2196/51899.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ladda Thiamwong, PhD, RN principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physio-feedback, Cognitive reframing and Peer-led exercises in people with Fall and Fear of Falling, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ladda Thiamwong, PhD, RN (407-823-2744, Ladda.Thiamwong@ucf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Fall Risk Reduction (time frame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778604, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.