Peripheral Arterial Disease(PAD)NCT06618131
Effects of Virtual Reality Exercises on Individuals With Peripheral Artery Disease
A study testing Exercise in people with Peripheral Arterial Disease(PAD), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Arterial Disease(PAD)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of epilepsy
- Dementia
- Chronic diseases that may be contraindications for exercise
Trial locations and contacts
1 site in 1 country.
Faculty of Physical Therapy and Rehabilitation Dokuz Eylul University contact
Turkey (Türkiye)1 site
Dokuz Eylul University Faculty of Physical Therapy and Rehabilitation
Izmir, 35340
Faculty of Physical Therapy and Rehabilitation, +90 232 277 50 30, fiziktedavi@deu.edu.tr
Meriç YILDIRIM, Associate Professor, +90 232 - 4124938 - 24938, meric.senduran@deu.edu.tr
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease(PAD)
- Being tested
- Exercise
- Keywords
- virtual reality, exercise, arterial stiffness, gait analysis, skin temperature
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise program with virtual reality applications for lower extremities
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise |
| Control Group | No intervention | In this group of 12 people, there will be no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twelve weeks
Secondary outcomes (5)
Arterial Stiffness Measurement
Arterial stiffness represents the viscoelastic properties of the vessel wall, indicates vascular damage and is a measure of the degree of atherosclerosis. Increased arterial stiffness or decreased compliance is indicative of extensive atherosclerotic involvement of the vasculature. One of the non-invasive techniques used to assess arterial stiffness is pulse wave analysis (PWA). PWA examines pressure waveforms within the main arteries. Pulse wave velocity (PWV) and enhancement index (Alx) are indices of arterial stiffness.PWV is the velocity of the pulse propagating along the arterial segment. Alx is the ratio of the difference between the late systolic pressure reflected from the periphery and the early systolic pressure to the pulse pressure, expressed as a percentage. The SphygmoCor XCEL device will be used to assess arterial stiffness.
Measured: Twelve weeks
Wearable Motion Analysis System
The dynamic gait parameter will be assessed with the BTS G-Walk Device, a wearable movement analysis system. The BTS G-Walk sensor system is a wireless magnetic sensor device that can be used to determine spatio-temporal parameters as well as pelvic movements during walking. The system consists of many parameters that analyze movements such as walking, running and jumping. In gait analysis, this system compares bilateral right and left limbs with normal values, and provides kinematic analysis of the pelvis in 3 planes.
Measured: Twelve weeks
Six-Minute Walk Test
The test will be performed along a 30 meter long by 1.5 meter wide corridor according to standard procedures developed by the American Thoracic Society. Participants will be instructed to walk along the 30-meter corridor from the starting point to the end at the best speed they can within 6 minutes, using standard encouragement phrases at the beginning of each minute. Modified Borg Scale will be used for dyspnea and leg fatigue perception. At the end of the test, the total distance covered will be recorded in meters (m). The calculation of percentage values will be based on the reference values formulated by Enright et al. in healthy population.
Measured: Twelve weeks
Walking Impairment Questionnaire (WIQ)
To assess intermittent claudication, the Turkish adaptation of the 21-item self-report scale Decreased Walking Distance Scale developed by Dr. Regensteiner et al. (1995) will be used. The scale consists of claudication, differential diagnosis, distance, speed and stair parameters. The sub-parameters (distance, speed and stairs) are rated on a Likert scale ranging from 0 (unable, very difficult) to 4 (no difficulty at all) and each item has a weighted score. The claudication and differential diagnosis section is assessed individually, while the subscales are assessed on a scale of 0 to 100 points, calculated according to the weight of each question. The subscale score is obtained by dividing the Likert scale score by the maximum weighted score and multiplying by 100. Each subscale score is evaluated between 0-100. A high score indicates high performance. Total and combined scores are calculated by averaging the subscales.
Measured: Twelve weeks
Short Version of Physical Activity Enjoyment Scale
The physical activity enjoyment scale is an 18-item scale developed to assess the enjoyment of physical activity in young adults (Kendzierski \& DeCarlo, 1991). The short form of the physical activity enjoyment scale (8 questions) was adapted from the original 18-item scale by Raedeke. The Turkish validity and reliability of the scale was conducted by Soylu et al. The Exercise Enjoyment Scale consists of 8 items with a 7-point Likert-type rating and a single dimension. The scale evaluates positive emotions such as enjoyment and pleasure from exercise. A high mean score on the scale indicates that the level of enjoyment from exercise is high, while a low mean score on the scale indicates that the level of enjoyment from exercise is low.
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease(PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayten Demir, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618131
- Sponsor's protocol ID
- DEU-FTR-AE-01
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The reason for not sharing data is the concern about unauthorized use.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06618131
- Acronym / sponsor ID
- DEU-FTR-AE-01
- Conditions
- Peripheral Arterial Disease(PAD)
- Keywords
- virtual reality, exercise, arterial stiffness, gait analysis, skin temperature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercising with Virtual Reality | Active comparator | Other: Exercise12 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. |
| Control Group | No intervention | –In this group of 12 people, there will be no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise program with virtual reality applications for lower extremities | Other | Exercising with Virtual Reality |
Primary outcome
Lower Extremity Skin Temperature,
Time frame: Twelve weeks
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.
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No. The reason for not sharing data is the concern about unauthorized use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Physical Therapy and Rehabilitation Dokuz Eylul University contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Peripheral Arterial Disease(PAD), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayten Demir, Graduate Student (+90 232 277 50 30 ext. +90 5520255054, aytenersoz35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Skin Temperature, (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.