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临床试验/NCT03456414
NCT03456414已完成不适用

Virtual Reality Exercise During Hemodialysis

Cardenal Herrera University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月11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
40
试验地点
2
主要终点
Change from baseline gait speed at 12 weeks

研究概览

简要总结

The main objective of this investigation is to assess if an intradialysis virtual reality exercise-based program results in an improvement in physical function and if it results in high adherence rates to exercise. The secondary aim is to assess the effect of intradialysis VR in physical activity level, health related quality of life and in cognitive function.

详细描述

Participants will be randomized into one of two groups. The first group will start with 12 weeks of virtual reality exercise during hemodialysis and will carry on with a control period of 12 weeks. The second group will start with a control period of 12 weeks (no exercise) and will carry on with a virtual reality exercise period of 12 weeks.

The virtual reality exercise will undertake up to 30 minutes of exercise. After warming up, participants will play to an adapted 'treasure hunt' game. Their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. The aim of the game will be to achieve the higher possible score.They will move their legs to pick up coins and to avoid bombs. An adapted Kinect technology will be used for the game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

A team of assessors, different to the researchers implementing the exercise, will record all dependent variables

入排标准

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

入选标准

  • At least 3 months in hemodialysis treatment
  • Clinically stable

排除标准

  • Recent cardiac events (less than 3 months)
  • Unable to exercise

结局指标

主要结局

Change from baseline gait speed at 12 weeks

时间窗: Baseline, 12 weeks

Speed to cover 4 meters at normal speed

次要结局

  • Change from baseline Physical activity level at 12 weeks(Baseline, 12 weeks)
  • Change from baseline Cognitive function at 12 weeks(Baseline, 12 weeks)
  • Change from baseline short physical performance battery at 12 weeks(Baseline, 12 weeks)
  • Adherence(12 weeks)
  • Change from baseline sit to stand 10 at 12 weeks(Baseline, 12 weeks)
  • Change from baseline timed up and go at 12 weeks(Baseline, 12 weeks)
  • Change from baseline one-leg standing test at 12 weeks(Baseline, 12 weeks)
  • Change from baseline one-leg heel rise test at 12 weeks(Baseline, 12 weeks)
  • Healthcare resources expenditure and costs(12 months before starting the exercise program- 12 months after the starting date)
  • Change from baseline sit to stand 60 at 12 weeks(Baseline, 12 weeks)
  • Change from baseline handgrip at 12 weeks(Baseline, 12 weeks)
  • Change from baseline 6 minutes walk test at 12 weeks(Baseline, 12 weeks)
  • Change from baseline Health related quality of life at 12 weeks(Baseline, 12 weeks)

研究者

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Segura Ortí

Professor

Cardenal Herrera University

研究点 (2)

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