Clinical trial NCT06618131: Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease(PAD)
Keywords: virtual reality
exercise
arterial stiffness
gait analysis
skin temperature
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Lower Extremity Skin Temperature,
timeFrame: Twelve weeks
Secondary outcomes:
measure: Arterial Stiffness Measurement
timeFrame: Twelve weeks
measure: Wearable Motion Analysis System
timeFrame: Twelve weeks
measure: Six-Minute Walk Test
timeFrame: Twelve weeks
measure: Walking Impairment Questionnaire (WIQ)
timeFrame: Twelve weeks
measure: Short Version of Physical Activity Enjoyment Scale
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Faculty of Physical Therapy and Rehabilitation
Study officials:
References: