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

This study evaluates a home-based strengthening program supported by the BandPass system, which includes a Bluetooth-enabled resistance exercise band, a mobile app that provides real-time feedback, and a clinician dashboard for remote monitoring. The goal of this clinical trial is to determine whether older adults living independently can feasibly use the BandPass system and whether participation in a BandPass-guided strengthening program improves functional performance.

The main questions this study seeks to answer are:

Whether older adults can independently and consistently use the BandPass system as part of a structured home-based strengthening program (feasibility and acceptability).

Whether the BandPass-guided program improves functional outcomes, including lower-extremity strength, mobility, and gait performance.

Participants will complete a 12-week home strengthening program using the BandPass system, attend in-person and virtual assessment visits to measure strength and mobility, and complete questionnaires related to usability, safety, and overall experience. If successful, this study will provide preliminary evidence supporting the use of remote monitoring technologies to promote strength, mobility, and independence in aging adults and inform the design of future larger-scale trials.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Sarcopenia
• Intervention / Treatment: Device: BandPass System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Viviana Nieto, BS; Phone Number: 919-962-3412; Email: Viviana_Nieto@med.unc.edu
• Study Contact Backup: Name: John Batsis, MD; Phone Number: 919-843-4096; Email: John.Batsis@unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Eastowne Medical Office Building
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Chapel Hill School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English speaking
• Age 65 or older
• Willing to use the BandPass device
• Access to high-speed internet Wi-Fi at home
• Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) Survey score of =4 or Frail Scale Survey score of 3-5

Exclusion Criteria:

• A medical record diagnosis of dementia -research activities require the ability to engage in the intervention, complete questionnaires and interact with others, all of which may be challenging in individuals with cognitive impairment
• Cognitive impairment measured by the 6-item Callahan screener
• Psychiatric diagnosis that would interfere with study participation and require significant modification to meet their needs such as major depressive disorder, substance abuse, suicidal ideation or severe mental illness (schizophrenia, bipolar disorder)
• A medical record diagnosis of a vestibular disorder
• A medical record diagnosis of fall risk
• Life-threatening illness including those receiving palliative care or hospice services
• Nursing facility or hospital admission in the past three months that is deemed to be contraindicated by the PI to participate
• Individuals unwilling/unable to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bandpass Strengthening Program; Participants will complete an 8-week home-based strengthening program using the BandPass system. All participants will perform strengthening exercises three times per week and complete in-person and virtual functional assessments.	Device: BandPass System; The BandPass system consists of a Bluetooth-enabled resistance exercise band paired with a mobile application that provides real-time feedback on exercise performance and transmits data to a clinician dashboard for remote monitoring. Participants will use the BandPass system for all strengthening sessions during the 8-week intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Session Adherence to the Bandpass System	Exercise session adherence will be assessed as the percentage of prescribed BandPass-supported strengthening sessions completed by participants over the 8-week intervention period. Participants are prescribed three strengthening sessions per week. Adherence will be calculated as: (number of completed sessions ÷ number of prescribed sessions) × 100. Adherence will be summarized at Weeks 4 and 8 to evaluate feasibility and continued use of the BandPass system among older adults.	0, 4, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Speed from Baseline	Gait speed will be assessed using the 4-meter walk test. Participants will be instructed to walk at their usual pace over a 4-meter course, and the time to complete the course will be recorded in seconds. Gait speed will be calculated as distance (4 meters) divided by time (seconds), reported in meters/second (m/s). The outcome will be expressed as change in gait speed from baseline to Week 4 and from baseline to Week 8, with positive values indicating faster walking speed.	0, 4, 8 weeks
Change in 30-Second Sit-to-Stand Performance from Baseline	This is a construct of physical function that predicts falls and disability and is sensitive to change. The 30-second sit-to-stand test is administered using a folding chair without arms and involves recording the number of stands from a seated position a person can complete in 30 seconds. Change in 30-second sit-to-stand repetitions will be reported from baseline to Week 4 and from baseline to Week 8. An improvement in repetitions will represent an improvement in physical function. The continuous value correlates with quadriceps Minimal Clinically Important Difference (2.0 repetitions).	0, 4, 8 weeks
Change in Grip Strength from Baseline	An objective measure related to upper extremity strength that predicts mobility disability. Using a Jamar dynamometer, change in participants' maximal grip strength will be measured in kilograms. Absolute change in grip strength will be reported from baseline to Week 4 and from baseline to Week 8. An increase in kilograms will represent an improvement in physical function. No cutoffs will be used, and analyses will use the continuous value.	0, 4, 8 weeks
Change in Patient reported outcomes measurement information systems (PROMIS) - Global health	PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health gauges physical, mental, and social aspects of health using a standardized 5-point scale. Scores are standardized to the general population (mean = 50, SD = 10; range 0-100), with higher scores indicating better health. Change in PROMIS Global Health scores will be assessed from baseline to Week 4 and from baseline to Week 8.	0, 4, 8 weeks
Change in Patient reported outcomes measurement information systems - Physical function	PROMIS Physical Function is a self-reported measure of mobility and activities of daily living using a standardized 5-point scale. Scores are standardized to the general population (mean = 50, SD = 10; range 0-100), with higher scores indicating better physical function. Change in PROMIS Physical Function scores will be assessed from baseline to Week 4 and from baseline to Week 8.	0, 4, 8 weeks
Change in Pittsburgh Fatigability questionnaire	The 15-item Pittsburgh Fatigability Scale measures perceived fatigue related to sedentary, social, lifestyle, and physical activities across a range of intensities (0-50 scale). Higher scores indicate greater perceived physical or mental fatigability, and scores ≥15 (physical) or ≥13 (mental) indicate higher fatigability that may lead to reduced performance or restricted activity. Change in Pittsburgh Fatigability scores will be assessed from baseline to Week 4 and from baseline to Week 8. A reduction in score will represent an improvement in fatigability.	0, 4, 8 weeks
Change in Exercise Self-Efficacy	The Self-Efficacy for Exercise Scale (range 0-90) is based on Social Cognitive Theory, with higher scores indicating greater confidence in initiating and maintaining exercise behaviors. Change in exercise self-efficacy scores will be assessed from baseline to Week 4 and from baseline to Week 8. Positive changes will reflect improved self-efficacy, while negative changes will reflect reduced self-efficacy.	0, 4, 8 weeks
Change in Technology Self-Efficacy	A 10-item Likert scale (1-10) will be used to assess daily technology self-efficacy, with higher scores indicating greater self-efficacy (range 0-100). Change in Technology Self-Efficacy scores will be assessed from baseline to Week 4 and from baseline to Week 8.	0, 4, 8 weeks
Change in Treatment Self-Regulation: Exercise	A validated 15-item, 7-point scale (range 0-100) reflecting autonomous and controlled motivation for exercise. Change in Treatment Self-Regulation scores will be assessed from baseline to Week 4 and from baseline to Week 8, with higher scores indicating better outcomes.	0, 4, 8 weeks
Change in Patient activation measure	The Patient Activation Measure assesses knowledge, skills, and confidence for managing one's health, providing insight into motivation, behaviors, attitudes, and outcomes (score range 0-100, with higher scores indicating greater activation). Change in Patient Activation Measure scores will be assessed from baseline to Week 4 and from baseline to Week 8.	0, 4, 8 weeks
Change in Older Americans Resources and Services (OARS) Functional Assessment Score	The Older Americans Resources and Services (OARS) Functional Assessment is a self-reported measure of functional ability in activities of daily living (ADLs) and instrumental activities of daily living (IADLs). Scores are calculated according to standard OARS scoring procedures, with higher scores indicating greater functional independence (score ≥12 indicating no impairment). Change in OARS Functional Assessment scores will be assessed from baseline to Week 4 and from baseline to Week 8.	0, 4, 8 weeks
Change in Outcome Expectancies for Exercise and Technology Use	Outcome expectancies for exercise and technology use will be assessed using a self-reported questionnaire evaluating participants' beliefs about their ability to prevent or improve loss of strength, muscle mass, and overall health through physical activity and use of technology. Participants respond using a 4-point Likert scale ranging from strongly agree to strongly disagree, with higher agreement indicating more positive outcome expectancies. Change in outcome expectancy scores will be assessed from baseline to Week 4 and from baseline to Week 8.	0, 4, 8 weeks
Change in System Usability Scale (SUS) Score	System usability will be assessed using the System Usability Scale (SUS), a validated self-reported questionnaire that measures perceived usability of a system. The SUS consists of 10 items, each rated on a 5-point Likert scale ranging from strongly disagree to strongly agree. Item responses are scored and summed according to standard SUS scoring procedures to generate a total score ranging from 0 to 100, with higher scores indicating better perceived system usability. The outcome will be expressed as the change in SUS total score from 4 weeks to 8 weeks.	4, 8 weeks
Change in Learnability Score of the BandPass System	Learnability of the BandPass system will be assessed using a self-reported questionnaire evaluating ease of use, confidence, navigation, and ability to use the system seamlessly over time. Participants rate items related to the BandPass resistance exercise band, the BandPass app, and the combined system using 10-point Likert-type scales. Higher scores indicate greater perceived ease of learning and confidence in using the system. Change in learnability scores from 4 weeks to 8 weeks will be reported.	4, 8 weeks
Change in Efficiency and Technology Acceptance Questionnaire Scores	Technology acceptance and efficiency will be measured using a self-reported questionnaire evaluating confidence in independent device use, perceived usefulness, convenience, burden, satisfaction, and efficiency. Scores are generated using 10-point Likert-type scales and summarized according to standard scoring procedures, with higher scores indicating more positive perceptions of technology acceptance and efficiency. Change in efficiency and technology acceptance scores will be assessed from Week 4 to Week 8.	4, 8 weeks
Change in User Experience Questionnaire (UEQ) Scores	User experience of the BandPass system will be assessed using the User Experience Questionnaire (UEQ), a validated self-reported questionnaire that evaluates participants' perceptions of the system across multiple dimensions, including attractiveness, clarity, efficiency, dependability, stimulation, and novelty. The UEQ consists of paired contrasting attributes rated on a 7-point semantic differential scale ranging from 1 to 7, with higher scores indicating a more positive user experience. Scores will be calculated according to standard UEQ scoring procedures. Change in UEQ scores from 4 weeks to 8 weeks will be reported.	4, 8 weeks
Telehealth Usability Survey	A single-item Likert scale (1-10) will be used to assess perceived usefulness, ease of use, effectiveness, reliability, and satisfaction with the BandPass system (range 0-100), with higher scores indicating better outcomes. Scores will be assessed at Week 4 and Week 8, and change in Telehealth Usability Survey scores between these timepoints will be reported.	4, 8 weeks
Change in Usefulness, Ease of Use, Ease of Learning, and Satisfaction Questionnaire Scores	Perceived usefulness, ease of use, ease of learning, and satisfaction with the BandPass system will be assessed using a self-reported questionnaire. The questionnaire includes items evaluating effectiveness, productivity, usefulness, efficiency, ease of use, flexibility, learnability, error recovery, and overall satisfaction with the system. Items are rated on a Likert-type scale ranging from strongly disagree to strongly agree. Higher scores indicate more positive perceptions of the system. Change in questionnaire scores from 4 weeks to 8 weeks will be reported.	4, 8 weeks
Willingness to Pay for the BandPass System	Willingness to pay for the BandPass system will be assessed using a self-reported questionnaire evaluating participants' willingness to pay for the application and exercise device and their willingness to travel to an exercise center in lieu of using the system in a home setting. Participants select predefined cost ranges and travel time categories reflecting perceived value and acceptability of the system.	8 weeks

Collaborators and Investigators

• Sponsor: SynchroHealth LLC
• Collaborators: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Eric Ryan, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Older Adults; Physical Function; Mobility; Bandpass
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Frailty; Sarcopenia
• Other Study ID Numbers: 24-2804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study data is proprietary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No