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临床试验/NCT04010981
NCT04010981已完成不适用

Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease.

Acibadem University2 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2018年7月30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
16
试验地点
2
主要终点
Functional Capacity-6-Minute Walking Test

研究概览

简要总结

In this study, we aim to improve respiratory function and balance of decreased muscle strength, decrease fatigue values, improve quality of life, improve inflammation findings and GFR ( Glomerular filtration rate) values in pediatric chronic kidney patients with virtual reality exercise applications.

详细描述

1.Group - Working group: Virtual reality technology (Nintendo Wii Fit Plus) exercise group 2.Group-Control group: home-based video games will be divided into groups that exercise.

Measurements of functional capacity, muscle strength, quality of life, depression, fatigue and physical activity levels, medical values (pulmonary function test values, inflammation level values, glomerular filtration rate level values) of both groups will be recorded before and after treatment.

In the study group treatment protocol; patients will complete 12 sessions of virtual reality exercise application-Nintendo Wii Fit Plus 30-minute training sessions with strengthening exercises for the lower extremities and upper extremities, aerobic and balance exercises. They will do 5 minutes warm-up exercises before the session and 5 minutes cool-down exercises as well as breathing exercises at the end of the session and will participate in a 50-minute treatment session in total.

In the control group treatment protocol, patients will follow the 30-minute video exercise practices for the lower and upper extremities that are similar to Nintendo Wii Fit exercises for the control group at home two days a week. exercises will complete the 50-minute training session. Apart from exercise sessions, patients will record their activities (walking, cycling, swimming…) in daily life forms with their own pedometers. Thus, changes in physical activity levels will be monitored.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • 6-18 years of age
  • to be chronic kidney disease,
  • to have chronic kidney disease at least 6 months
  • to have no visual hearing impairment

排除标准

  • Attending another exercise program,
  • to have severe infection (sepsis, peritonitis)
  • Having anorexia or other growth retardation,
  • Mental retardation,
  • Inadequate communication in Turkish,
  • Failure to communicate,
  • Cardiomyopathy,
  • presence of angina pectoris,
  • Standing and walking obstacle
  • Presence of orthopedic problem
  • Cerebrovascular disease
  • Patients with lower limb amputation and not using orthosis-prosthesis,
  • patients with metastatic carcinoma will not be included in the study.

结局指标

主要结局

Functional Capacity-6-Minute Walking Test

时间窗: 6 Weeks

Functional capacity is assessed by 6 minute walk test at the baseline and after 6 weeks

Muscle strength

时间窗: 6 Weeks

The strength of the lower and upper extremity muscles is measured with a digital dynamometer.

次要结局

  • Lung Parameters- Forced vital capacity (FVC), forced expiratory volume 1 second(6 Weeks)
  • Quality of life MEASURE(6 Weeks)
  • Fatigue(6 Weeks)
  • Participation(6 Weeks)

研究者

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

Irmak ÇAVUŞOĞLU

Principal Investigator

Acibadem University

研究点 (2)

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