Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT05432674
The Digital Fall Prevention Study is a single-group unblinded study to explore the feasibility and acceptability of a 3-month fall prevention exercise program delivered digitally via a tablet interface. Evidence-based exercise programs and motivational techniques will be used along with new wearable technology to predict fall risk.
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Notify Me65 year and older
All sexes
Interventional
Phase 1 / Phase 2
Boston, Massachusetts, 02115, United States
The goal of this study is to demonstrate the feasibility and acceptability of a digital fall prevention exercise program and to explore whether there is benefit from participating in such programs. This study will include 30 older adults who are at higher risk of falling or have a fear of falling and living at home. All participants will receive the intervention. All participants will be assessed pre- and post-intervention on measures of sensor-based fall risk, sensor-based frailty, falls self-efficacy, technology readiness, feasibility and acceptability, utilization and participation, frailty, grip strength, depression, anxiety, and physical activity (both self-report and using wearable sensors).
The overall hypothesis is that a prototype system consisting of wearable sensors and a tablet will be feasible and acceptable in a population of older adults with increased risk for falls and fall-related injuries or with a fear of falling.
Aim 1: To determine the feasibility and acceptability of a self-guided, digitally delivered, in-home exercise program for older adults with elevated fall risk.
Aim 2: To determine the clinical effects of implementing a fall prevention intervention program via the remote platform.
Exploratory Aim 1: Investigate differences in frailty, cognitive status, physical function, mental health status and technology readiness between participants who successfully adhere to the study program versus those that do not.
The study will take place in two settings. The first setting is at the Men's Health, Aging, and Metabolism research division at Brigham and Women's Hospital, including the Laboratory of Exercise Physiology and Physical Performance (LEPPP) at 221 Longwood Ave, Boston, MA 02115. The second will be in the homes of older adults within the general community who meet the inclusion criteria.
Intervention
Participants who enroll in the study will receive a wearable device, a tablet, a tablet stand, and ankle weights for home use, along with instructions and charging accessories. Participants will participate in a 3-month moderate-intensity exercise intervention, which will be supported by a LEPPP study staff member trained and certified in the intervention and delivered remotely through the tablet. The program is designed to gradually progress in intensity and exercise duration over a 12-week period. The exercise intervention parameters will be tailored to individual ability and progressed by the study interventionist based on feedback from participants, motivational coaching calls, and post-exercise surveys.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exercises delivered through a tablet and remote motivational calls
Time frame: over the 12 weeks of the intervention
Percentage of scheduled exercise sessions complete (70% of sessions completed = acceptable adherence)
Time frame: at final (12-week) assessment
a self-report measure of the intervention feasibility, score range is 1-5, higher score = greater feasibility
Time frame: at final (12-week) assessment
a self-report measure of acceptability of the intervention, score range is 1-5, higher score = greater acceptability
Time frame: change from baseline to 12-weeks
fear of falling measure, score range from 16-64, higher score=less fear of falling
Time frame: at final (12-week) assessment
a self-report measure of the intervention appropriateness, score range is 1-5, higher score = greater appropriateness
Time frame: change from baseline to 12-weeks
cognitive status assessment, score range 0-30, higher score=better cognition
Time frame: change from baseline to 12-weeks
cognitive assessment
Time frame: change from baseline to 12-weeks
measure of frailty in older people, index range from 1-5, higher score=increased frailty
Time frame: change from baseline to 12-weeks
maximal isometric contraction of hand measured using a Jamar Handheld Dynamometer in kilograms
Strength (force) will be measured in kilograms.
Time frame: change from baseline to 12-weeks
self-report physical activity scale, score range 0 to 400, higher score=more activity
Time frame: change from baseline to 12-weeks
fall risk assessed using a sensor and computer based program
Time frame: change from baseline to 12-weeks
frailty assessed using a sensor and computer based program
Time frame: change from baseline to 12-weeks
physical performance mobility test
Time frame: at final (12-week) assessment
a self-report measure of the acceptance of the technology used in the intervention
Brigham and Women's Hospital
Other
Digital Fall Prevention Feasibility Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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