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临床试验/NCT05361200
NCT05361200招募中不适用

Effects of Patient-Specific Adaptive Dynamic Cycling on Function Improvement in Individuals With Parkinson's Disease

Kent State University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Change in motor kinematics

研究概览

简要总结

Parkinson's disease (PD) is a progressive neurological disorder that results in slowness of movement, muscle stiffness, tremor, and postural instability. These symptoms significantly affect PD patients' quality of life, independence, and functional performance. There is currently no cure for PD, but symptoms can be treated with levodopa or deep brain stimulation surgery. Exercise-based rehabilitation has similar beneficial effects to surgical and pharmacological management without the potential negative side effects. Cycling-based interventions have been shown to increases motor function and mobility in individuals with PD. Specifically, benefits are greater when cycling cadence (revolutions per minute, RPM) is 30% greater than a self-selected pace.

Although high cadence cycling improves motor function in individuals with PD, there is significant heterogeneity in individual responses. To maximize the treatment effects and minimize the heterogeneity of high-cadence cycling, it is important to determine patient-specific settings. Previous studies have shown that higher variability (entropy) of cadence leads to greater improvement in motor function. The entropy of cadence calculation will be utilized to understand how patient-specific settings can drive improvements. The purpose of this study is to determine patient-specific settings and measure the effects of high cadence stationary (i.e. dynamic) cycling on functional performance in individuals with PD. Volunteers with Parkinson's disease will complete 12 cycling sessions over a 1-month period and measures of motor function, quality of life, functional performance, mood and exercise readiness will be collected.

详细描述

Potential participants will be prescreened with the ACSM pre-participation questionnaire over the phone or in person. Those who qualify will be asked to visit the research lab and sign the informed consent. Participants will be randomized into one of two groups: 1) patients-specific adaptive dynamic cycling or 2) non-adaptive dynamic cycling. Both groups will participate in a total of 12 sessions, each session consisting of 5 minutes of warm-up, 30 minutes of the main exercise, and 5 minutes of the cool-down period. For the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. The optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. After optimization, participants will receive specific settings for the next session. For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participant will not be told which group they were assigned to

入排标准

年龄范围
50 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic Parkinson's disease
  • 50-79 years of age
  • no contraindications to exercise including cardiovascular disease or stroke

排除标准

  • one or more major signs/symptoms of cardiovascular or pulmonary disease

研究组 & 干预措施

Adaptive dynamic cycling

Experimental

For the patient-specific adaptive dynamic cycling group, the optimization process will be done after the 3rd, 6th, and 9th sessions. The optimization procedure is based on sample entropy of cadence calculation from the previous session's cycling performance. After optimization, participants will receive specific settings for the next session.

干预措施: Dynamic high-cadence cycling (Behavioral)

Non-adaptive dynamic cycling

Active Comparator

For the non-adaptive group, individuals will cycle on the dynamic bike with pre-determined settings that will stay constant throughout the exercise protocol.

干预措施: Dynamic high-cadence cycling (Behavioral)

结局指标

主要结局

Change in motor kinematics

时间窗: 4 weeks

Kinesia One- Accelerometry- Lower score represents milder symptoms

Change in motor symptoms

时间窗: 4 weeks

MDS-UPDRS Motor III (Movement Disorders Society- Unified Parkinson's Disease Rating Scale) Minimum Score-0 Maximum Score- 138 Lower score represents improvement

次要结局

  • Change in quality of life(4 weeks)
  • Change in mobility(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Ridgel

Professor, School of Health Sciences

Kent State University

研究点 (2)

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