Therapeutic game-based exercise during hemodialysis to improve balance and mobility

血液透析期间基于游戏的治疗性运动，以改善平衡和活动能力

• 批准号: 9408377
• 负责人: Bijan Najafi
• 金额: $ 22.5万
• 依托单位: BIOSENSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9408377
• 关键词: Activities of Daily Living; Address; Adherence; Age; Ankle; Anxiety; Area; Back; Balance training; Biofeedback; Blood Vessels; Blood flow; Cardiovascular system; Chronic Kidney Failure; Clinic; Clinic Visits; Clinical; Clinical Trials; Clinical effectiveness; Code; Cognitive; Comorbidity; Computer software; Computers; Control Groups; Coupled; Development; Dialysis procedure; Dropout; Effectiveness; Elderly; Eligibility Determination; Engineering; Equilibrium; Evaluation; Exercise; Fatigue; Foot Ulcer; Gait; Gait speed; Hemodialysis; Hour; Immobilization; Incidence; Individual; Industrialization; Intervention; Lead; Legal patent; Lower Extremity; Measurement; Medical Device; Medicine; Mental Depression; Modeling; Motion; Motor; Muscular Atrophy; Musculoskeletal Equilibrium; Nephrology; Outcome Measure; Patients; Perception; Performance; Perfusion; Peripheral Nervous System Diseases; Peripheral arterial disease; Phase; Physical activity; Pilot Projects; Play; Population; Process; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Recruitment Activity; Rehabilitation therapy; Risk; Rotation; Sampling; Skin; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Supervision; System; Technology; Testing; Therapeutic; Therapeutic exercise; Time; Training Programs; Transportation; Treatment Efficacy; Walking; Wireless Technology; ankle joint; base; clinical practice; college; commercialization; computerized; deconditioning; design; dosage; exercise intervention; exercise program; fall risk; falls; fear of falling; foot; frailty; group intervention; high risk; improved; improved mobility; intervention program; laptop; liver transplantation; mobility enhancement; peripheral blood; primary outcome; programs; prototype; psychosocial; secondary outcome; sedentary lifestyle; sensor; uptake; user-friendly

Abstract Chronic kidney disease (CKD) disproportionately impacts older adults(1). Balance, mobility, and falls are serious problems for CKD patients due to associated peripheral neuropathy and peripheral arterial disease, which also contribute to foot ulcers and other foot problems in this population. Among older adults these problems are often compounded by other comorbid conditions leaving older adults with CKD at a particularly high risk for falls (2-4). Patients with CKD require hemodialysis unless and until they can receive a liver transplant. These patients visit clinics multiple times a week and must sit or lie still for hours (~4 hours) at a time while receiving hemodialysis. This, coupled with generally low activity levels, leads to further deconditioning of the lower extremities, muscle wasting, and an increased risk of falls. Exercise interventions have been shown to improve mobility and balance, reduce the incidence of falls, and improve peripheral blood flow, which is essential to reduce foot problems and peripheral arterial disease (5-8). However, uptake of exercise programs for individuals who are undergoing hemodialysis (HD) process has been limited (9). The three main factors limiting uptake and adherence among HD patients are time availability, post- dialysis fatigue, and transportation to exercise programs, which are usually offered in rehabilitation departments or cardiovascular centers but not in nephrology departments or in free-standing dialysis clinics (9) To address the factors limiting uptake and adherence of therapeutic exercise among HD individuals we have developed a game-based exercise program (Exergame platform) that can be performed while receiving HD. The exergaming system consists of a wireless inertial sensor worn on the dorsum of each foot and a laptop computer. The sensors track 3D motion while patients move their feet (ankle joint rotations) to navigate a computer cursor to execute motor-cognitive exercise tasks. This real-time ankle/foot motion biofeedback exercises sensorimotor control. Patients do not need to be supervised during the exercise session because the exergames are computerized, low risk (patients remain seated or recumbent), and performance is tracked automatically. We have developed a prototype and tested its feasibility. In summary, 11 HD patients were randomly assigned to either the intervention group with Exergame platform (IG: n=7) or the control group without exergame platform (CG: n=4). Both groups underwent a 4 weeks lower extremities exercise program during HD sessions, twice per week for duration of 30-min. Significant improvement in gait and balance was observed in the IG group after 8 sessions of exercise compared to the baseline measurements. These preliminary results support the scientific premise and feasibility to implement exergame intervention in HD clinics. Through this STTR project we will transfer our exergame platform from Baylor College of Medicine to BioSensics LLC for further development and commercialization. In Phase I we will improve the industrial design of the sensor and evaluate the efficacy of the intervention program for hemodialysis patients in a convenience sample of 15 HD individuals. We will investigate the effects of the proposed exergaming program on gait, balance, lower extremity vascular performance, daily physical activity, and fatigue. The clinical effectiveness of the proposed platform will be further examined during Phase II based on a randomized controlled trial that will be powered based on the results of the Phase I pilot study.

摘要 慢性肾脏病（CKD）对老年人的影响不成比例（1）。平衡、移动和福尔斯是严重的 CKD患者由于相关的周围神经病变和周围动脉疾病而出现的问题， 导致足部溃疡和其他足部问题。在老年人中，这些问题往往是 与其他合并症相结合，使患有CKD的老年人的福尔斯跌倒风险特别高（2-4）。 CKD患者需要血液透析，除非他们可以接受肝移植。这些患者访问 在接受血液透析时，患者必须一次静坐或静卧数小时（约4小时）。 这与通常的低活动水平相结合，导致下肢、肌肉和骨骼的进一步失调。 消瘦和增加的福尔斯风险。 运动干预已被证明可以改善流动性和平衡，减少福尔斯的发生率， 改善外周血流量，这对减少足部问题和外周动脉疾病至关重要（5-8）。 然而，接受血液透析（HD）过程的个体的运动计划的摄取已经被限制。 有限（9）。限制HD患者摄取和依从性的三个主要因素是时间可用性、术后 透析疲劳，以及通常在康复部门提供的运动计划的运输 或心血管中心，但不是肾病科或独立的透析诊所（9） 为了解决HD个体中限制治疗性运动的摄入和坚持的因素，我们 开发了一个基于游戏的锻炼计划（游戏游戏平台），可以在接收高清时进行。的 exergaming系统由一个无线惯性传感器和一台笔记本电脑组成，传感器戴在每只脚的背上。 当患者移动他们的脚（踝关节旋转）以导航计算机光标时，传感器跟踪3D运动 来执行运动认知训练任务。这种实时踝/足运动生物反馈练习感觉运动 控制患者在锻炼过程中不需要监督，因为锻炼游戏是 计算机化，低风险（患者保持坐着或躺着），性能自动跟踪。我们 开发了一个原型，并测试了其可行性。总之，11例HD患者被随机分配 干预组7名，采用运动游戏平台，对照组7名，不采用运动游戏 平台（CG：n=4）。两组在HD期间均接受4周的下肢运动计划， 每周两次，持续30分钟。IG组观察到步态和平衡的显著改善 与基线测量值相比，8次运动后。这些初步结果支持了 在HD门诊开展运动游戏干预的科学前提和可行性。 通过这个STTR项目，我们将把我们的exergame平台从贝勒医学院转移到 BioSensics LLC进行进一步开发和商业化。在第一阶段，我们将改善工业 设计的传感器，并评估干预方案的血液透析患者在一个 15个HD个体的便利样本。我们将调查拟议的exergaming计划的影响 步态、平衡、下肢血管性能、日常体力活动和疲劳。临床 拟议平台的有效性将在第二阶段根据随机 对照试验，将根据I期初步研究的结果进行检验。