Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease

NCT06618131 | Not Yet Recruiting

• 1 other identifier: DEU-FTR-AE-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease(PAD)

Keywords

virtual reality; exercise; arterial stiffness; gait analysis; skin temperature

Outcome Measures

Primary Outcomes (1)

• Lower Extremity Skin Temperature,

  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.

  Twelve weeks

Secondary Outcomes (5)

• 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 Arms (2)

Exercising with Virtual Reality

ACTIVE COMPARATOR

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.

Other: Exercise

Control Group

NO INTERVENTION

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

Interventions

Exercise OTHER

Exercise program with virtual reality applications for lower extremities

Exercising with Virtual Reality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University Faculty of Physical Therapy and Rehabilitation

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ayten Demir, Graduate Student

CONTACT

+90 232 277 50 30; aytenersoz35@gmail.com

Faculty of Physical Therapy and Rehabilitation Dokuz Eylul University

CONTACT

+90 232 277 50 30; fiziktedavi@deu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)