BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline Phase II Aim 4

Purpose: Consistent with the research priorities of the National Institute on Aging to support mobility, strength, and functional independence in older adults, this protocol will evaluate the feasibility, acceptability, and preliminary efficacy of the BandPass system, a remote monitoring platform consisting of a Bluetooth-enabled resistance exercise band, a mobile application providing real-time feedback, and a clinician dashboard for remote oversight. This Phase II Aim 4 trial examines whether a home-based strengthening intervention supported by BandPass can be feasibly implemented in older adults at risk for sarcopenia or functional decline, and whether participation leads to improvements in physical function, including lower-extremity strength, gait speed, and mobility.

Procedures (Methods): This is an 8-week, single-arm, pre/post intervention trial enrolling 39 older adults aged 65 years and older who are at risk for sarcopenia, frailty, or functional decline. Participants will complete a structured home-based strengthening program using the BandPass system three times per week. Baseline in-person assessments will include strength testing, gait assessment, mobility measures, body composition, and device training. At Week 4, participants will complete a virtual visit for interim assessment of functional status. At Week 8, they will return for repeat functional testing and usability surveys. Throughout the intervention, participants will use the BandPass resistance band and mobile app for all strengthening sessions, with real-time feedback on effort, tempo, and repetitions. Exercise data will be automatically transmitted to the clinician dashboard, allowing the study team to monitor adherence, performance, and safety. Participants will complete weekly surveys regarding usability, comfort, and perceived exertion, and may contact study staff with questions or concerns at any point. Safety monitoring, adverse event tracking, and protocol fidelity procedures will be conducted throughout the study.

Aim 1: Evaluate the feasibility and acceptability of deploying the BandPass system in older adults at risk for sarcopenia or frailty. We hypothesize that BandPass will be feasible and acceptable, with at least 80% of participants reporting satisfaction with the system and at least 75% of prescribed sessions completed.

Aim 2: Examine the preliminary efficacy of the 8-week BandPass-guided strengthening program on physical function. Improvements are expected in measures including grip strength, Short Physical Performance Battery scores, gait speed, and chair stand performance from baseline to Week 8.

Aim 3: Characterize patterns of engagement with the BandPass system, including exercise frequency, duration, force output, tempo, and repetition quality. These metrics will be used to inform optimization of future technology-supported strengthening interventions and to guide development of larger-scale trials.

• Change in Gait Speed from Baseline [Срок оценки: 0, 4, 8 weeks]
• Change in 30-Second Sit-to-Stand Performance from Baseline [Срок оценки: 0, 4, 8 weeks]
• Change in Grip Strength from Baseline [Срок оценки: 0, 4, 8 weeks]
• Change in Patient reported outcomes measurement information systems (PROMIS) - Global health [Срок оценки: 0, 4, 8 weeks]
• Change in Patient reported outcomes measurement information systems - Physical function [Срок оценки: 0, 4, 8 weeks]
• Change in Pittsburgh Fatigability questionnaire [Срок оценки: 0, 4, 8 weeks]
• Change in Exercise Self-Efficacy [Срок оценки: 0, 4, 8 weeks]
• Change in Technology Self-Efficacy [Срок оценки: 0, 4, 8 weeks]
• Change in Treatment Self-Regulation: Exercise [Срок оценки: 0, 4, 8 weeks]
• Change in Patient activation measure [Срок оценки: 0, 4, 8 weeks]
• Change in Older Americans Resources and Services (OARS) Functional Assessment Score [Срок оценки: 0, 4, 8 weeks]
• Change in Outcome Expectancies for Exercise and Technology Use [Срок оценки: 0, 4, 8 weeks]