Optimizing a Technology-based Body and Mind Intervention

NCT05778604 | Recruiting DMC

• 2 other identifiers: STUDY00003260R01MD018025
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up

Secondary Outcomes (2)

• Change from Baseline in Fall Risk Appraisal Shifting

  Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up

• Change from Baseline in Negative Self-perceptions of Aging

  Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up

Other Outcomes (5)

• Change in Social determinants of health

  Baseline and 6 month follow-up

• Change from Baseline in Depression

  Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up

• Change from Baseline in Anxiety

  Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up

Study Arms (2)

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.

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.

Behavioral: CDC older adults fall prevention

Interventions

Physio-feedback BEHAVIORAL

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.

Physio-fEedback Exercise pRogram (PEER) Group

Cognitive reframing BEHAVIORAL

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.

Physio-fEedback Exercise pRogram (PEER) Group

Peer-led exercises BEHAVIORAL

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.

Physio-fEedback Exercise pRogram (PEER) Group

CDC older adults fall prevention BEHAVIORAL

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.

Attention Control (AC) Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 33825688 BACKGROUND

• Thiamwong 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.

  PMID: 33378743 BACKGROUND

• Thiamwong 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.

  PMID: 32286669 BACKGROUND

• Thiamwong 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.

  PMID: 32219456 BACKGROUND

• Thiamwong 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.

  PMID: 31713464 BACKGROUND

• Suarez 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.

  PMID: 40839173 DERIVED

• Tice 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.

  PMID: 40035084 DERIVED

• Thiamwong 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.

  PMID: 37788049 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ladda Thiamwong, PhD, RN

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ladda Thiamwong, PhD, RN

CONTACT

407-823-2744; Ladda.Thiamwong@ucf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At all follow-up outcome points, the accessor will be blind to the study arm each participant was randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We will employ an intention-to-treat, single- blinded, parallel, two-arm clustered randomized controlled trial (RCT).

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 21, 2023
• Study Start: April 12, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)