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

NCT07421648 | Not Yet Recruiting

• 1 other identifier: 24-2804
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sarcopenia; Frailty

Keywords

Bandpass; Older Adults; Physical Function; Mobility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Change in Gait Speed from Baseline

  0, 4, 8 weeks

• Change in 30-Second Sit-to-Stand Performance from Baseline

  0, 4, 8 weeks

• Change in Grip Strength from Baseline

  0, 4, 8 weeks

• Change in Patient reported outcomes measurement information systems (PROMIS) - Global health

  0, 4, 8 weeks

• Change in Patient reported outcomes measurement information systems - Physical function

  0, 4, 8 weeks

Study Arms (1)

Bandpass Strengthening Program

EXPERIMENTAL

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

Interventions

BandPass System DEVICE

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.

Bandpass Strengthening Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SynchroHealth LLC: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (2)

UNC Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27514, United States

Location

UNC Eastowne Medical Office Building

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Eric Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviana Nieto, BS

CONTACT

919-962-3412; Viviana_Nieto@med.unc.edu

John Batsis, MD

CONTACT

919-843-4096; John.Batsis@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)