Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease

NCT ID: NCT06618131

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease(PAD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercising with Virtual Reality

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Exercise program with virtual reality applications for lower extremities

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

Exercise program with virtual reality applications for lower extremities

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayten Demir

Graduate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dokuz Eylul University Faculty of Physical Therapy and Rehabilitation

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ayten Demir, Graduate Student

Role: CONTACT

+90 232 277 50 30 ext. +90 5520255054

Faculty of Physical Therapy and Rehabilitation Dokuz Eylul University

Role: CONTACT

+90 232 277 50 30

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Faculty of Physical Therapy and Rehabilitation

Role: primary

+90 232 277 50 30

Meriç YILDIRIM, Associate Professor

Role: backup

+90 232 - 4124938 - 24938

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DEU-FTR-AE-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Self-Managed Walking Improves Function
NCT00611988 COMPLETED PHASE2