NCT05432674

Digital Fall Prevention Study

Digital Fall Prevention Feasibility Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. * Hypothesis 1a): The technology (wearable sensor and tablet) and digitally delivered fall prevention exercises will be feasible and acceptable to older people at risk for falls. * Hypothesis 1b): The technology (wearable sensor and tablet) and digitally delivered fall prevention exercise program will reduce a user's concern of falling Aim 2: To determine the clinical effects of implementing a fall prevention intervention program via the remote platform. • Hypothesis 2): Participants who adhere to the program, completing at least 70% of the video exercise sessions, will see a pre- to post-intervention reduction in quantitative measures of fall risk. 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.

Conditions

• Fall

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Digital Fall Prevention	Exercises delivered through a tablet and remote motivational calls

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-05-25
• Completion: 2023-06-01
• First posted: 2022-06-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States