Optimizing a Technology-based Body and Mind Intervention
- Conditions
- Fear of FallingPhysical InactivitySedentary BehaviorFall
- Registration Number
- NCT05778604
- Lead Sponsor
- University of Central Florida
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 340
- ≥ 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from Baseline in Fall Risk Reduction 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 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 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 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).
- Secondary Outcome Measures
Name Time Method Change from Baseline in Negative Self-perceptions of Aging Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up 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.
Change from Baseline in Fall Risk Appraisal Shifting Baseline and 9 weeks, 3 month follow-up, and 6 month follow-up 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).
Trial Locations
- Locations (1)
University of Central Florida
🇺🇸Orlando, Florida, United States
University of Central Florida🇺🇸Orlando, Florida, United StatesLadda Thiamwong, PhD, RNPrincipal Investigator