Optimizing a Technology-based Body and Mind Intervention
NCT05778604 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340
Last updated 2023-04-26
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.
Conditions
- Fall
- Fear of Falling
- Physical Inactivity
- Sedentary Behavior
Interventions
- BEHAVIORAL
-
Physio-feedback
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.
- BEHAVIORAL
-
Cognitive reframing
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.
- BEHAVIORAL
-
Peer-led exercises
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.
- BEHAVIORAL
-
CDC older adults fall prevention
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.
Sponsors & Collaborators
-
National Institute on Minority Health and Health Disparities (NIMHD)
collaborator NIH -
University of Central Florida
lead OTHER
Principal Investigators
-
Ladda Thiamwong, PhD, RN · University of Central Florida
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-12
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
Countries
- United States
Study Locations
More Related Trials
-
Health in Motion- A Pragmatic Clinical Trial- Home
NCT05016141 ·Status: COMPLETED ·Phase: NA
-
A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult
NCT06363942 ·Status: RECRUITING ·Phase: NA
-
Effectiveness of Impairment Specific Exercises for Balance and Fall Risk in Community-Living Older Adults at Risk: A Randomized Controlled Trial
NCT02615899 ·Status: COMPLETED ·Phase: NA
-
Does Participation in a Fall Preparedness Program Improve Fall Efficacy Among Older Adults
NCT06545539 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Aging and Task-specific Training to Reduce Falls
NCT07094659 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Home Based Exercise in Preventing Fall and Improving Balance in Older People
NCT02089815 ·Status: COMPLETED ·Phase: NA
-
Prevention of Falls in General Practitioner for Community-dwelling Older Adults [PreFalls]
NCT01032252 ·Status: COMPLETED ·Phase: PHASE4
-
Effectiveness of Adapted Physical Activity Programs in Preventing Falls in People Aged Over 65
NCT06985719 ·Status: NOT_YET_RECRUITING
-
Implementation of a Multifactorial Falls Prevention Intervention in Older Community-dWElling peRsons
NCT06105437 ·Status: COMPLETED ·Phase: NA
-
Study of Static and Dynamic Posturographic Elements Predictive of Falls in the Institutionalized Elderly
NCT05171036 ·Status: UNKNOWN ·Phase: NA
-
Real-life Dual-Task Training
NCT06479694 ·Status: RECRUITING ·Phase: NA
-
Motor Training for Fall Prevention
NCT01621958 ·Status: COMPLETED ·Phase: NA
-
Minimizing Fall-Related Injury in Older Adults: a Motor Learning Approach
NCT05260034 ·Status: COMPLETED ·Phase: NA
-
HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults
NCT05583578 ·Status: COMPLETED ·Phase: NA
-
Physical Condition and Self-efficacy in People With Fall Risk
NCT02746835 ·Status: COMPLETED ·Phase: NA
-
Digital Fall Prevention Study
NCT05432674 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Strategies for Preventing Falls in the Elderly
NCT06089213 ·Status: COMPLETED ·Phase: NA
-
Effects of a Falls Prevention Program Following Hospital Discharge
NCT02995486 ·Status: COMPLETED ·Phase: NA
-
Effect of Adaptive Training for Balance Recovery
NCT02126488 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii)
NCT02570178 ·Status: COMPLETED ·Phase: NA
-
Using Consumer-grade Wearable Devices for Fall Risk Evaluation and Alerts
NCT06508892 ·Status: RECRUITING
-
A Multi-domain and Multi-component Falls Intervention Program for Community- Dwelling Older Adults: SAFE-TECH
NCT06102954 ·Status: RECRUITING ·Phase: NA
-
Identifying and Treating Physical Function Impairment in Elders
NCT02044783 ·Status: COMPLETED ·Phase: NA
-
Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation
NCT06535477 ·Status: TERMINATED ·Phase: NA
-
Fall Prevention in Older Adults Study
NCT03176511 ·Status: COMPLETED ·Phase: NA