BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline Phase II Aim 4
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Exercise Session Adherence to the Bandpass System
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: BandPass System (Device)
结局指标
主要结局
Exercise Session Adherence to the Bandpass System
时间窗: 0, 4, 8 weeks
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.
次要结局
- 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)
- Change in Pittsburgh Fatigability questionnaire(0, 4, 8 weeks)
- Change in Exercise Self-Efficacy(0, 4, 8 weeks)
- Change in Technology Self-Efficacy(0, 4, 8 weeks)
- Change in Treatment Self-Regulation: Exercise(0, 4, 8 weeks)
- Change in Patient activation measure(0, 4, 8 weeks)
- Change in Older Americans Resources and Services (OARS) Functional Assessment Score(0, 4, 8 weeks)
- Change in Outcome Expectancies for Exercise and Technology Use(0, 4, 8 weeks)
- Change in System Usability Scale (SUS) Score(4, 8 weeks)
- Change in Learnability Score of the BandPass System(4, 8 weeks)
- Change in Efficiency and Technology Acceptance Questionnaire Scores(4, 8 weeks)
- Change in User Experience Questionnaire (UEQ) Scores(4, 8 weeks)
- Telehealth Usability Survey(4, 8 weeks)
- Change in Usefulness, Ease of Use, Ease of Learning, and Satisfaction Questionnaire Scores(4, 8 weeks)
- Willingness to Pay for the BandPass System(8 weeks)