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临床试验/NCT03193268
NCT03193268已完成不适用

Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility

Somogy Megyei Kaposi Mór Teaching Hospital2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2
试验地点
2
主要终点
Borg test

研究概览

简要总结

Determine the short-term and lasting effects of intensity-matched exercise programs on level 2-3 PD patients' clinical symptoms, postural control, and mobility.

Hypothesis

  1. The inclusion of a Borg-scale/heart-rate matched active control group will allow us to test the idea that, in addition to a fitness element, the reflexive movements that chellenge PD patients' sensorimotor system will improve patients' clinical symptoms, posture, and mobility more than fitness training and that such lasting effects will be superior in the agility compared with the fitness-control group. This hypothesis emered from the idea that the favorable results in the currently under review paper may be in part due to a simple conditioning effect instead of a specific motor learning effect caused by the xbox training.
  2. If feasible, i.e., if there is a lerge enough pool of patients to randomize, a balance training group will be also added to test the idea that the reflexive actions evoked by the agility program by xbox exergaming still produce superior adaptations vs. the balance group because xbox forces patients to rapidly and reflexively execute movements (respond to cues, prompts), while balance training allows patients to stop, go, stop, and go and disrupt the continous execution of linked movements. The disruptions of movement chains could arise from small losses of balance on the unstabel surfaces, need for patients to re-initiate every movement element of a sequence, planning each movement element. It is not clear yet how it woul be possible to match all three intervention groups on Borg/heart rate intensity.

详细描述

Agility: Xbox based high intensity program, as detailed in the submitted manuscript. Borg scale after after each exercise block is recorded. Heart rate continuosly measured. These data are used to set intensity in the fitness group.

Fitness: A stationary bicycle ergometer program that includes visual stimulation in the form of watching nature programs and movies to account for visual stimulus in Agility group. Mean heart rate and Borg scale readings from Agility group will form the target intensity.

Control: No-exercise, measurment-only control group.

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 (Investigator)

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parkinson's disease,
  • Hoenh Yahr scale of 2-3,
  • instability problem,

排除标准

  • Severe heart problems, severe demeanor, alcoholism, drug problems,

结局指标

主要结局

Borg test

时间窗: 0-40 point (5 week-long, higher score is better)

Fatigue questionnaire

PDQ-39

时间窗: 0-39 scale (5week-long, higher score is better)

special Parkinson's Disease test - motor and no-motor function

EQ5D-5L

时间窗: 0-5 scale (5 weeks-long, the higher score is better)

Questionnaire

SPPB test (gait, balance, leg stregth)

时间窗: 0-12 scale (5 week-long, higher score is better)

Walking and balance testing

次要结局

未报告次要终点

研究者

发起方
Somogy Megyei Kaposi Mór Teaching Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tollár József

Principal Investoigator

Somogy Megyei Kaposi Mór Teaching Hospital

研究点 (2)

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