Optimizing a Technology-based Body and Mind Intervention

University of Central Florida

Status: Enrolling

Conditions: Physical Inactivity; Fear of Falling; Fall; Sedentary Behavior

Treatments: Behavioral: CDC older adults fall prevention; Behavioral: Physio-feedback; Behavioral: Cognitive reframing; Behavioral: Peer-led exercises

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05778604

STUDY00003260

R01MD018025 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 2 patient groups

Physio-fEedback Exercise pRogram (PEER) Group

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive reframing

Behavioral: Physio-feedback

Behavioral: Peer-led exercises

Attention Control (AC) Group

Experimental group

Description:

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.

Treatment:

Behavioral: CDC older adults fall prevention