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临床试验/NCT02023034
NCT02023034已完成不适用

EFFECTIVENESS OF VIRTUAL EXERCISES ON THE FUNCTIONAL EXERCISE CAPACITY, FATIGUE AND QUALITY OF LIFE IN PATIENTS WITH PARKINSON'S DISEASE: A RANDOMIZED CLINICAL TRIAL

Faculdade Evangelica do Parana1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Improvement of functional exercise capacity

研究概览

简要总结

Introduction: Although the motor changes are well determined in Parkinson's disease (PD), few studies describe the effects the virtual exercises on the clinical and functional outcomes in this disease.

Objectives: To analyze the effectiveness of virtual exercises on functional exercise capacity, fatigue and quality of life in patients with PD.

Methods: 20 subjects, 60 years old will be included, who will be randomized into 2 groups: group of virtual exercises associated with conventional exercises (n = 10) and control group with conventional exercise group (n = 10).

The following variables are evaluated: functional exercise through walking test in 6 minutes, fatigue by the Fatigue Severity Scale and Quality of Life through Quality of Life Questionnaire-PDQ-39.

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 (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • will be selected for the study
  • subjects with a clinical diagnosis of Parkinson's disease
  • 0-III H&Y
  • 40 to 80 years
  • both sexes
  • with preserved cognitive stage (Mini Mental> 24).

排除标准

  • will be excluded subjects who have some acute pain or associated diseases
  • such as severe or unstable heart disease
  • visual disturbances
  • using some march auxiliary device, which compromise the 6MWT and exercise protocol

研究组 & 干预措施

Virtual exercises

Experimental

All patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers, the period instrument used was the video game with the Nintendo ® Wii Balance Board ® platform.

干预措施: Virtual exercises (Other)

Control

Sham Comparator

Traditional exercises. All patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers.

干预措施: Virtual exercises (Other)

结局指标

主要结局

Improvement of functional exercise capacity

时间窗: The subjects will be followed for a period of 90 days.

Assessed by the 6-minute walk test (6MWT), according to the guidelines of the American Thoracic Society, which is based on the evaluation of the maximum distance traveled by the patient for six minutes, expressed in meters.

次要结局

  • Reduction of Fatigue(The subjects will be followed for a period of 90 days.)

研究者

发起方
Faculdade Evangelica do Parana
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Valderramas

Silvia Valderramas

Faculdade Evangelica do Parana

研究点 (1)

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