Abstract
<sec> <title>BACKGROUND</title> <p>Increasing physical activity, including exercise, for older adults (OAs) is an almost universally beneficial strategy for reducing frailty and improving management of multimorbidity, thereby preserving independence. However, homebound, frail, multimorbid OAs have very limited access to exercise programs in the U.S., and prior exercise intervention trials are frequently based on in-person classes / coaching and rarely involve care partners. Increasing exercise among multimorbid, frail, homebound [EC2.1]OAs requires testing innovative methods of intervention delivery.</p> </sec> <sec> <title>OBJECTIVE</title> <p>The EngAGE trial is a 6-month, double blind, randomized controlled, in-home trial powered to test the efficacy of the EngAGE program versus paper-based NIA Go4Life® exercises in multimorbid, frail, homebound African American OAs residing in the community along with their self-selected care partners (CPs).</p> </sec> <sec> <title>METHODS</title> <p>EngAGE is a custom, socially-motivated exercise program delivering NIA Go4Life® exercises to multimorbid, frail, homebound OAs and their CPs in the home. We co-designed EngAGE with end users using iterative participatory design. The program delivers daily exercise (resistance, balance and flexibility) routines to OAs over a voice-activated device with a screen. CPs can provide social reinforcement that is read aloud to the OA over the device to motivate adherence. OA-CP dyads were randomized to either the: 1) EngAGE program (EngAGE arm), or 2) the NIA “Workout to Go” Go4Life® exercise handout along with an out-of-the-box voice-activated device (paper arm). The primary outcome is change in the performance of five repeated chair stands from the Short Physical Performance Battery. Secondary study outcomes were selected to: (a) further assess individual-level factors that may contribute to exercise participation and response, (b) examine the OA-CP social factors that may impact exercise participation and response, and (c) assess technology-related factors. An intention-to-treat analysis principle will be applied to all outcomes. A two-part mixed model to compare chair stands over time will be used. The first part will model the probability of being able to perform chair stands by a random-effects logistic regression, and the second part will compare chair stands performance time among those who are able to perform the test by a linear mixed model.</p> </sec> <sec> <title>RESULTS</title> <p>Funding began in July 2021. Recruitment occurred from October 2022 to February 2025 (n = 69 OA and n = 68 care partner). Data collection concluded in April 2026. Data analysis and submission for publication are expected to conclude by summer 2026.</p> </sec> <sec> <title>CONCLUSIONS</title> <p>The EngAGE trial will be one of the first RCTs that tests the impact of mode of delivery on the efficacy of a health intervention for multimorbid, frail, homebound OAs. It is also among the first to include CPs as a target participant of an OA physical activity intervention. Trial findings will generate guidance for future randomized controlled trials with OAs at highest risk of disability.</p> </sec> <sec> <title>CLINICALTRIAL</title> <p>ClinicalTrials.gov NCT05337514; https://clinicaltrials.gov/study/NCT05337514</p> </sec>