Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease

Dokuz Eylül University (DEU)

Status: Not yet enrolling

Conditions: Peripheral Arterial Disease(PAD)

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06618131

DEU-FTR-AE-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Exercising with Virtual Reality

Active Comparator group

Description:

12 participants will undergo a virtual reality exercise program with the X-Box 360 KinectTM game console (X-Box 360, Microsoft, United States of America) for 50 minutes a day, 2 days a week for 12 weeks.

Treatment:

Other: Exercise

Control Group

No Intervention group

Description:

In this group of 12 people, there will be no intervention.