An interventional study of Exercise in Peripheral Arterial Disease(PAD), sponsored by Dokuz Eylul University. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 24 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
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
In this group of 12 people, there will be no intervention.
Exercise program with virtual reality applications for lower extremities
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.
Time frame: Twelve weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Twelve weeks
Plan to share: No — The reason for not sharing data is the concern about unauthorized use.
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Dokuz Eylul University