Forced Exercise: A New Therapy for the Treatment of Parkinson's Disease

强迫运动：治疗帕金森病的新疗法

• 批准号: 8056993
• 负责人: Andrew Levine
• 金额: $ 19.62万
• 依托单位: XTHERA CORPORATION
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8056993
• 关键词: Address; Age; Agreement; Animal Model; Back; Bicycling; Boxing; Clinic; Clinical; Computer software; Cues; Deep Brain Stimulation; Effectiveness; Electronics; Elements; Engineering; Exercise; Feedback; Goals; Heart Rate; Home environment; Individual; Industry; Intervention; Leg; Marketing; Measures; Medical; Microelectrodes; Modification; Monitor; Motor; Muscle; Operative Surgical Procedures; Parkinson Disease; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physical Efforts; Physical Function; Pilot Projects; Price; Regimen; Reporting; Resistance; Signal Transduction; Site; Small Business Innovation Research Grant; Solutions; System; Testing; Therapeutic; Time; Training; Work; advanced disease; base; clinical efficacy; clinical research site; commercialization; design; disability; efficacy testing; implantation; improved; innovation; man; meetings; motor control; performance tests; prototype; success

DESCRIPTION (provided by applicant): A small pilot study by Alberts and team (Cleveland Clinic) suggests that sustained forced exercise (FE) may be as or more effective than medication or surgical implantation of microelectrodes for deep brain stimulation in improving motor function in individuals with Parkinson's disease (PD). In FE, an individual actively exercises at a rate in excess of that which (s)he is physically able to attain and maintain by (her)himself. In the Alberts' study, patients completed three 40 min FE sessions/week for 8 weeks, using a stationary tandem bicycle on which a "trainer" provided ~75% of the energy required to maintain a cadence of 80-90 rpm and the patient provided sufficient energy to maintain a target heart rate 80% of maximum for their age. Somewhat surprisingly, this regimen improved upper as well as lower body motor function. Unfortunately, commercialization of this FE regimen would be prohibitively expensive, requiring a healthy trainer to man the front seat of the stationary tandem and a supervisor to insure the targeted level of FE was reached and maintained. RSS Industries, Inc. proposes to design, build and bench test the performance of a motorized exercise cycle prototype, the Theracycle PD, able to replace the physical input provided by the trainer in the Alberts' FE regimen. The starting point will be the existing Theracycle, a stationary, software-controlled motor driven therapeutic exercise system developed and manufactured by RSS and launched in 2002 for use by individuals with significant physical disabilities. Innovations and enhancements to be implemented during the 1 year SBIR Phase I work plan will enable the prototype Theracycle PD to: 1) allow the rider to achieve FE by overdriving the motor; and 2) use the rider's heart rate as part of a control loop to signal when more pedaling effort is required to maintain target heart rate (and FE) and when the motor can provide the effort. Specific aims (SAs) include: SA1. Replace existing gear box on a standard Theracycle with a back-drivable, low resistance gearing system. SA 2: Develop and integrate a heart rate monitor, electronic components, enhanced GUI and requisite soft- ware. SA 3: Build and release test 3 additional prototype Theracycle PD units for use in clinical efficacy testing of FE regimens in SBIR Phase II (4 units total; 1 primary and 1 backup for each of 2 clinical sites). Feasibility/Progression Criteria: The heart rate and pedal cadence values achieved during the FE period on the Theracycle PD prototypes must be within 10% of the range of values reported in the Alberts' pilot study. No attempt will be made to ascertain effectiveness of the FE regimen as that will be addressed in SBIR Phase II. PUBLIC HEALTH RELEVANCE: Individuals with Parkinson's disease (PD) suffer progressive loss of upper and lower body motor functions, for which drug therapy becomes less and less effective over time. A recent pilot study suggests that forced exercise on a tandem bicycle (in which a second rider aids in pedaling at a rate well above that achievable by a PD patient's voluntary effort) can produce whole body improvements in motor function at least as good as and possibly better than those achieved by medication in patients with advanced disease. The work proposed here is designed to create the Theracycle PD, a stationary exercise cycle using a motor to replace the physical effort provided by the second rider, with the long term goal of making forced exercise an affordable (<$5000) option available to a much wider group of PD patients.

描述（由申请人提供）：阿尔伯茨和团队（克利夫兰诊所）的一项小型试点研究表明，持续的强制运动（FE）可能比药物或手术植入微电极的脑刺激，以改善个体的运动功能，以提高或更有效帕金森氏病（PD）。在FE中，一个人以超过（S）能够（她）自己的身体能力并维持自己的身份的速度积极锻炼。在阿尔伯特的研究中，患者使用固定的串联自行车完成了三​​个40分钟的Fe疗程，持续了8周，“培训师”在该自行车上提供了〜75％的能量，以维持80-90 rpm的节奏所需的能量和患者。提供了足够的能量，以维持目标心率的80％的最大年龄。令人惊讶的是，该方案改善了上身和下半身运动功能。不幸的是，这种FE疗法的商业化将非常昂贵，需要一名健康的教练才能使固定串联的前排座位和主管确保达到目标的FE水平并维护。 RSS Industries，Inc。建议设计，构建和替补测试电动运动周期原型Theacycle PD的性能，能够替代培训师在Alberts'Fe方案中提供的物理输入。起点将是现有的Theracycle，这是由RSS开发和制造的固定的，软件控制的运动驱动的治疗运动系统，并于2002年推出，旨在由具有重要身体残疾的人使用。在1年SBIR I期工作计划中将实施的创新和增强功能将使原型Thencycle PD到：1）允许骑手通过超越电动机来实现FE； 2）使用骑手的心率作为控制循环的一部分，在需要更多的踩踏工作以保持目标心率（和FE）以及电动机可以提供努力时发出信号。具体目标（SAS）包括：SA1。用后驱动的低电阻齿轮系统在标准Theracycle上替换现有的齿轮箱。 SA 2：开发和整合心率监视器，电子组件，增强的GUI和必要的软件。 SA 3：构建和发行测试3其他原型THECYCLE PD单元用于SBIR II期FE方案的临床疗效测试（总计4个单位； 1个主要的1个单位和1个备份）。可行性/进展标准：在Theacycle PD原型的FE期间达到的心率和踏板节奏值必须在Alberts的初步研究中报告的值范围内的10％以内。不会试图确定FE方案的有效性，因为这将在SBIR II期中解决。 公共卫生相关性：患有帕金森氏病（PD）的人会逐渐丧失上半身运动功能，因为随着时间的流逝，药物疗法变得越来越少。最近的一项试点研究表明，在串联自行车上强迫锻炼（第二个骑手以高于PD患者的自愿努力来实现的速度有助于踩踏），可以至少可以在运动功能方面进行全身改善比在患有晚期疾病的患者中用药物实现的好。此处提出的工作旨在创建Theracycle PD，这是一种使用电动机的固定锻炼周期来代替第二把手提供的身体工作，其长期目标是使强迫锻炼成为负担得起的（<$ 5000）的选项（<$ 5000） PD患者组更广泛。