Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease(PAD). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other Exercise
Exercise program with virtual reality applications for lower extremities
Primary outcome measures
- Lower Extremity Skin Temperature, [Time frame: Twelve weeks]
Secondary outcome measures (5)
- Arterial Stiffness Measurement [Time frame: Twelve weeks]
- Wearable Motion Analysis System [Time frame: Twelve weeks]
- Six-Minute Walk Test [Time frame: Twelve weeks]
- Walking Impairment Questionnaire (WIQ) [Time frame: Twelve weeks]
- Short Version of Physical Activity Enjoyment Scale [Time frame: Twelve weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Dokuz Eylul University Faculty of Physical Therapy and Rehabilitation — Izmir
Identifiers
NCT: NCT06618131 · DEU-FTR-AE-01