CYClical Lower Extremity exercise for Parkinsons trial (CYCLE Trial)

帕金森试验的循环下肢运动（CYCLE Trial）

基本信息

批准号：
10399535
负责人：
JAY L. ALBERTS
金额：
$ 59.48万
依托单位：
CLEVELAND CLINIC LERNER COM-CWRU
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-01 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10399535
关键词：
Address Aerobic Aerobic Exercise Age Age of Onset Animal Model Behavioral Biomechanics Blinded Caring Characteristics Clinic Clinical Clinical assessments Control Groups Coupled Data Development Disease Disease Progression Effectiveness Enrollment Evaluation Exercise Future Gait Gait speed Gender Healthcare Heart Rate Home Human Image Individual Intervention Investigation Laboratories Lower Extremity Measures Modeling Monitor Motor Movement Disorder Society Unified Parkinson&apos s Disease Rating Scale Neuraxis Operative Surgical Procedures Outcome Parkinson Disease Participant Patient Recruitments Patient-Focused Outcomes Patients Pattern Performance Periodicity Persons Pharmaceutical Preparations Pharmacologic Substance Phenotype Property Protocols documentation Quality of life Randomized Randomized Clinical Trials Randomized Controlled Trials Recommendation Short-Term Memory Site Standardization Sum Supervision Symptoms Testing Time Trail Making Test Translations United States National Institutes of Health Universities Upper Extremity Utah Work base cognitive performance cohort comorbidity demographics effectiveness evaluation executive function exercise intensity exercise intervention exercise prescription exercise program heart rate variability illness length improved information processing motor control motor function improvement neurotrophic factor performance tests predicting response predictive modeling preservation primary outcome processing speed prognostic model programs wearable sensor technology

项目摘要

PROJECT SUMMARY/ABSTRACT Despite advances in pharmaceutical and surgical approaches to the treatment of Parkinson’s disease (PD), an effective disease modifying treatment remains elusive. Exercise is accepted as an adjunctive treatment to the disease; however, its disease altering properties are unclear. Data indicate that high intensity exercise has neuroprotective properties and improves motor functioning in animal models of PD. Our promising translational work in humans indicated aerobic exercise improves global motor function, upper extremity performance, and altered patterns of central nervous system activation. We recently completed a 100 person randomized clinical trial, CYClical Lower Extremity exercise for Parkinson’s trial (CYCLE Trial) (NIH R01NS673717), and results indicated an 8-week high intensity aerobic exercise program significantly improved MDS-UPDRS III scores, turning and gait speed, and information processing. The positive results persisted up to eight weeks after exercise cessation. These positive results provide strong rationale to evaluate the effectiveness of a long-term CYCLE protocol in a home-based setting in an effort to impact a greater number of individuals with PD. The primary aim of this project is to determine if long-term, high intensity aerobic exercise alters disease progression in individuals with PD. A pragmatic randomized clinical trial is proposed in which blinded clinical assessments will be coupled with biomechanical measures of motor and non-motor performance to determine the impact of high-intensity exercise on PD progression. In sum, 250 PD patients recruited from the Cleveland Clinic and University of Utah will be randomized to a high-intensity home exercise or usual and customary care (UCC) group. The CYCLE Trial protocol will be delivered to the home of the exercise group through the consumer-based Peloton Indoor Cycle, and participants will be instructed to exercise 3x/week for 12 months; the UCC group will be instructed to engage in their normal activities. The exercise and control groups will undergo identical motor and non-motor evaluation protocols at enrollment, 3, 6, 9, and 12 months. In addition to clinical measures such as the MDS-UPDRS III, systematic quantification of motor and non-motor outcomes will be collected using the PD-Performance Test (PD-PT), a validated set of biomechanical-based iPad applications created in Dr. Alberts’ lab. Overall activity levels will be monitored for both groups via a wearable sensor. Combining clinical and biomechanical measures of motor and cognitive performance will accelerate the investigation and understanding of potential mechanisms underlying the positive effects of exercise on disease progression. Finally, exercise performance data including heart rate, cadence and power from each session will be gathered to monitor exercise compliance and build an exercise response predictive model. The model will facilitate a transition from general recommendation to a patient-specific exercise prescription in which potential outcomes can be estimated.

项目概要/摘要尽管治疗帕金森病 (PD) 的药物和手术方法取得了进步，但有效的疾病缓解治疗仍然难以捉摸，运动被认为是一种辅助治疗。疾病；然而，其疾病改变特性尚不清楚。我们有希望的转化动物模型具有神经保护特性并改善运动功能。对人类的研究表明，有氧运动可以改善整体运动功能、上肢表现和我们最近完成了一项 100 人随机临床研究。试验，帕金森氏症试验的循环下肢运动（CYCLE 试验）（NIH R01NS673717）和结果表明为期 8 周的高强度有氧运动计划显着改善了 MDS-UPDRS III 评分，转弯和步态速度以及信息处理的积极结果持续到八周后。这些积极的结果为评估长期的有效性提供了强有力的理由。在家庭环境中实施 CYCLE 方案，努力影响更多的帕金森病患者。该项目的主要目的是确定长期、高强度的有氧运动是否可以改变疾病提出了一项实用的随机临床试验，其中盲法临床试验。评估将与运动和非运动表现的生物力学测量相结合，以确定总之，从克利夫兰招募了 250 名 PD 患者。诊所和犹他大学将随机进行高强度家庭锻炼或常规护理 (UCC) 小组将通过 CYCLE 试验方案将其送到练习小组的家中。基于消费者的 Peloton 室内自行车，参与者将被指导每周锻炼 3 次，持续 12 个月； UCC 小组将按照指示进行正常活动。在入组、第 3、6、9 和 12 个月时接受相同的运动和非运动评估方案。临床测量，例如 MDS-UPDRS III，运动和非运动结果的系统量化将使用 PD 性能测试 (PD-PT) 进行收集，这是一组经过验证的基于生物力学的 iPad 艾伯特博士实验室创建的应用程序将通过可穿戴设备监测两组的总体活动水平。结合运动和认知性能的临床和生物力学测量将加速。调查和理解运动对身体产生积极影响的潜在机制最后，运动表现数据，包括每次运动的心率、步频和功率。将召开会议以监测运动依从性并建立运动反应预测模型。模型将有助于从一般建议过渡到针对患者的特定运动处方可以估计哪些潜在结果。