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NCT Number: NCT06618131

Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Vertigo
  • History of epilepsy
  • Dementia
  • Chronic diseases that may be contraindications for exercise

Treatment and study plan

Exercise

Other

Exercise program with virtual reality applications for lower extremities

Primary outcomes

  1. 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

  1. Arterial Stiffness Measurement

    Time frame: Twelve weeks

    Arterial stiffness represents the viscoelastic properties of the vessel wall, indicates vascular damage and is a measure of the degree of atherosclerosis. Increased arterial stiffness or decreased compliance is indicative of extensive atherosclerotic involvement of the vasculature. One of the non-invasive techniques used to assess arterial stiffness is pulse wave analysis (PWA). PWA examines pressure waveforms within the main arteries. Pulse wave velocity (PWV) and enhancement index (Alx) are indices of arterial stiffness.PWV is the velocity of the pulse propagating along the arterial segment. Alx is the ratio of the difference between the late systolic pressure reflected from the periphery and the early systolic pressure to the pulse pressure, expressed as a percentage. The SphygmoCor XCEL device will be used to assess arterial stiffness.

  2. Wearable Motion Analysis System

    Time frame: Twelve weeks

    The dynamic gait parameter will be assessed with the BTS G-Walk Device, a wearable movement analysis system. The BTS G-Walk sensor system is a wireless magnetic sensor device that can be used to determine spatio-temporal parameters as well as pelvic movements during walking. The system consists of many parameters that analyze movements such as walking, running and jumping. In gait analysis, this system compares bilateral right and left limbs with normal values, and provides kinematic analysis of the pelvis in 3 planes.

  3. Six-Minute Walk Test

    Time frame: Twelve weeks

    The test will be performed along a 30 meter long by 1.5 meter wide corridor according to standard procedures developed by the American Thoracic Society. Participants will be instructed to walk along the 30-meter corridor from the starting point to the end at the best speed they can within 6 minutes, using standard encouragement phrases at the beginning of each minute. Modified Borg Scale will be used for dyspnea and leg fatigue perception. At the end of the test, the total distance covered will be recorded in meters (m). The calculation of percentage values will be based on the reference values formulated by Enright et al. in healthy population.

  4. Walking Impairment Questionnaire (WIQ)

    Time frame: Twelve weeks

    To assess intermittent claudication, the Turkish adaptation of the 21-item self-report scale Decreased Walking Distance Scale developed by Dr. Regensteiner et al. (1995) will be used. The scale consists of claudication, differential diagnosis, distance, speed and stair parameters. The sub-parameters (distance, speed and stairs) are rated on a Likert scale ranging from 0 (unable, very difficult) to 4 (no difficulty at all) and each item has a weighted score. The claudication and differential diagnosis section is assessed individually, while the subscales are assessed on a scale of 0 to 100 points, calculated according to the weight of each question. The subscale score is obtained by dividing the Likert scale score by the maximum weighted score and multiplying by 100. Each subscale score is evaluated between 0-100. A high score indicates high performance. Total and combined scores are calculated by averaging the subscales.

  5. Short Version of Physical Activity Enjoyment Scale

    Time frame: Twelve weeks

    The physical activity enjoyment scale is an 18-item scale developed to assess the enjoyment of physical activity in young adults (Kendzierski & DeCarlo, 1991). The short form of the physical activity enjoyment scale (8 questions) was adapted from the original 18-item scale by Raedeke. The Turkish validity and reliability of the scale was conducted by Soylu et al. The Exercise Enjoyment Scale consists of 8 items with a 7-point Likert-type rating and a single dimension. The scale evaluates positive emotions such as enjoyment and pleasure from exercise. A high mean score on the scale indicates that the level of enjoyment from exercise is high, while a low mean score on the scale indicates that the level of enjoyment from exercise is low.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayten Demir, Graduate Student

CONTACT

[email protected]

+90 232 277 50 30 ext. +90 5520255054

Faculty of Physical Therapy and Rehabilitation Dokuz Eylul University

CONTACT

[email protected]

+90 232 277 50 30

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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