Clinical trial NCT05778604: Optimizing a Technology-based Body and Mind Intervention
Official title: Optimizing a Technology-based Body and Mind Intervention to Prevent Falls and Reduce Health Disparities in Low-income Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-03-21
Enrollment: 340
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will employ an intention-to-treat, single- blinded, parallel, two-arm clustered randomized controlled trial (RCT).
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in Fall Risk Reduction
timeFrame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
measure: Change from Baseline in Dynamic Balance as Measured By Timed-Up and Go (TUG) test
timeFrame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
measure: Change from Baseline in Dynamic Balance as Measured By Sit-to-Stand test
timeFrame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
measure: Change from Baseline in Physical Activity
timeFrame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Secondary outcomes:
measure: Change from Baseline in Fall Risk Appraisal Shifting
timeFrame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
measure: Change from Baseline in Negative Self-perceptions of Aging
timeFrame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
Other outcomes:
measure: Change in Social determinants of health
timeFrame: Baseline and 6 month follow-up
measure: Change from Baseline in Depression
timeFrame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
measure: Change from Baseline in Anxiety
timeFrame: Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up
measure: Incidence of falls
timeFrame: Week 1 through Week 8
measure: Exercise adherence
timeFrame: Baseline through Week 8
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Ladda Thiamwong, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.