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临床试验/NCT06618131
NCT06618131尚未招募不适用

Examination of the Effects of Virtual Reality Exercises on Lower Extremity Skin Temperature, Arterial Stiffness, Gait Parameters and Enjoyment of Exercise in Individuals With Peripheral Arterial Disease

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
2
主要终点
Lower Extremity Skin Temperature,

研究概览

简要总结

The aim of this study is to investigate the effects of virtual reality exercises on lower extremity skin temperature, arterial stiffness, gait parameters and enjoyment of exercise in individuals with peripheral arterial disease.

详细描述

The number of studies conducted in individuals with peripheral arterial disease (PAD) is quite small. In the only existing study, it was found that the application of a walking program on a treadmill in a virtual environment created with virtual reality increased the walking distance of individuals with intermittent claudication. In this direction, our study was planned to determine the effect of exercise program with virtual reality application on skin temperature, arterial stiffness, gait parameters and exercise enjoyment in individuals with PAD.

The study group will receive an exercise program with X-Box 360 KinectTM game console (X-Box 360, Microsoft, United States) for 50 minutes a day, 2 days a week for 12 weeks, and the control group will receive only a home exercise program. Lower extremity skin temperature will be evaluated with a thermal camera (FLIR E53, FLIR Systems, Wilsonville, Oregon, USA), arterial stiffness will be evaluated with an arterial stiffness meter (SphygmocorXCEL device), gait parameters will be evaluated with a wearable movement analysis system (G-walk), 6 Minute Walk Test and Walking Impairment Questionnaire. Enjoyment of physical activity will be evaluated with The Short Version of Physical Activity Enjoyment Scale Assessments will be made as initial assessment before the exercise program, interim assessment at week 6 and final assessment at week 12.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being diagnosed with PAD
  • Being between 18-65 years of age
  • Ankle-brachial index less than 0.9
  • Not having a lower extremity injury or surgery that would prevent participation in the exercise program

排除标准

  • History of cardiovascular events less than 3 months before the start of the study
  • Uncontrolled severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
  • Uncontrolled diabetes mellitus (glycemic index ≥ 290)
  • Critical Limb Ischemia
  • Balance Problems
  • History of epilepsy
  • Chronic diseases that may be contraindications for exercise

结局指标

主要结局

Lower Extremity Skin Temperature,

时间窗: Twelve weeks

In our study, a thermal camera (FLIR E53, FLIR Systems, Wilsonville, Oregon, USA) with a temperature sensitivity of 0.04°C will be used to record lower extremity skin temperature with real-time imaging.Controls related to thermographic scaling will be performed according to Thermographic Imaging in Sports and Exercise Medicine (TISEM)" criteria.

次要结局

  • Arterial Stiffness Measurement(Twelve weeks)
  • Wearable Motion Analysis System(Twelve weeks)
  • Six-Minute Walk Test(Twelve weeks)
  • Walking Impairment Questionnaire (WIQ)(Twelve weeks)
  • Short Version of Physical Activity Enjoyment Scale(Twelve weeks)

研究者

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

Ayten Demir

Graduate Student

Dokuz Eylul University

研究点 (2)

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