BandPass System for Sarcopenia

Not yet recruiting at 1 trial location
VN
JB
Overseen ByJohn Batsis, MD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: SynchroHealth LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

ER

Eric Ryan, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

Inclusion Criteria

I have significant difficulty with strength and daily movements.
Willing to use the BandPass device
Access to high-speed internet Wi-Fi at home
See 2 more

Exclusion Criteria

Cognitive impairment measured by the 6-item Callahan screener
Life-threatening illness including those receiving palliative care or hospice services
Individuals unwilling/unable to provide consent
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline in-person assessments including strength testing, gait assessment, mobility measures, body composition, and device training

1 week
1 visit (in-person)

Treatment

Participants complete an 8-week home-based strengthening program using the BandPass system, with real-time feedback and remote monitoring

8 weeks
1 visit (virtual) at Week 4, 1 visit (in-person) at Week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment, including usability surveys and adherence monitoring

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BandPass System

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Bandpass Strengthening ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SynchroHealth LLC

Lead Sponsor

University of North Carolina, Chapel Hill

Collaborator

Trials
1,588
Recruited
4,364,000+