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Clinical Trials/NCT06618131
NCT06618131
Not yet recruiting
Not Applicable

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 University1 site in 1 country24 target enrollmentOctober 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease(PAD)
Sponsor
Dokuz Eylul University
Enrollment
24
Locations
1
Primary Endpoint
Lower Extremity Skin Temperature,
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2024
End Date
March 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ayten Demir

Graduate Student

Dokuz Eylul University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Lower Extremity Skin Temperature,

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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