Effects of Aerobic-Based Virtual Reality Exercise Training and Traditional Aerobic Exercise Training on Physical Fitness, Functional Capacity and Cognitive Function in Individuals with Down Syndrome
- Conditions
- Down SyndromeAerobic ExerciseVirtual Reality Based TherapyExergamePhysical FitnessFunctional CapacityCognitive Function
- Interventions
- Other: Aerobic Based Virtual Reality Exercise TrainingOther: Traditional Aerobic Exercise Training
- Registration Number
- NCT06617637
- Lead Sponsor
- Bezmialem Vakif University
- Brief Summary
This study aims to investigate the effectiveness of aerobic-based virtual reality exercise training and traditional aerobic exercise training on physical fitness, functional capacity, cognitive functions and quality of life in individuals with Down syndrome.
- Detailed Description
The most common chromosomal disorder caused by the presence of an extra copy of chromosome 21, resulting in Down syndrome. Individuals with Down syndrome have a higher prevalence of musculoskeletal, neurological, and cardiovascular system problems compared to healthy individuals. Physical activity and exercise play a significant role in the treatment of Down syndrome. Among the preferred exercise programs in treatment, aerobic exercise improves cardiorespiratory functions, has positive effects on physical fitness parameters, enhances quality of life, and improves cognitive function. In addition to traditional aerobic exercise training using devices such as bicycles and treadmills, virtual reality-based aerobic exercise training is also a widely used method. However, there is a lack of studies on the use of aerobic-based virtual reality exercises in individuals with Down syndrome in the literature. The studies available in the literature mainly focus on balance and postural control in virtual reality exercises.
This study aims to investigate the effectiveness of aerobic-based virtual reality exercise training compared to traditional aerobic exercise training on physical fitness, functional capacity, cognitive function, and quality of life in individuals with Down syndrome.
The study plans to include 40 participants with Down syndrome aged between 13 and 18 years. The participants will be divided into three groups: Aerobic-Based Virtual Reality Exercise Training Group, Traditional Aerobic Exercise Training Group and Control Group. The Aerobic-Based Virtual Reality Exercise Training Group will perform aerobic exercise training using Xbox Kinect 360 device, while the Traditional Aerobic Exercise Training Group will use a treadmill for aerobic exercise training. During the exercise training, participants heart rate and oxygen saturation will be monitored using a pulse oximeter, and the training will be supervised by a physiotherapist. The exercise program will be conducted twice a week for a total of 10 weeks. The individuals in the Control Group will be advised to continue their standard daily activities.
The physical fitness components of all participants will be evaluated using the Eurofit Test Battery. The Timed Up and Go Test and 6-Minute Walk Test will be used to assess participants submaximal functional capacities.The Childrens Quality of Life Scale will be used to assess quality of life, and The Behavior Rating Inventory of Executive Function will be used to evaluate cognitive function. To assess physical activity levels and monitor them, the participants will be administered the Godin Leisure-Time Exercise Questionnaire on a weekly basis for 10 weeks. The enjoyment of physical activities by the participants will be evaluated using the Physical Activity Enjoyment Scale.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 44
- According to DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) criteria, individuals with Down syndrome with mild to moderate intellectual disability
- Being able to understand the instructions in the assessment and exercise program
- Being willing to participate in the study
- Having participated in any structured exercise program in the last 6 months before participating in the study
- Having any heart disease or other chronic physical, behavioral or cognitive problems that limit their participation in the exercise program
- Having severe visual or auditory problems
- Having any history of surgery affecting musculoskeletal structures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerobic-Based Virtual Reality Exercise Training Group Aerobic Based Virtual Reality Exercise Training Aerobic exercise training will be applied to the aerobic-based virtual reality exercise group with an Xbox Kinect 360 (Microsoft, Washington, USA) for 20 sessions, 2 days a week, for 10 weeks. Traditional Aerobic Exercise Training Group Traditional Aerobic Exercise Training The traditional aerobic exercise group will receive treadmill training under the supervision of a physiotherapist 2 days a week for 10 weeks.
- Primary Outcome Measures
Name Time Method Eurofit Fitness Test Battery 3 months The Eurofit Fitness Test Battery is an assessment method consisting of a series of tests developed by the European Council in the 1980s to assess physical fitness. The Eurofit Test Battery is designed to be performed with simple equipment and in a short time, usually 25-40 minutes. This test battery evaluates different physical fitness components such as balance, speed, flexibility, explosive power, muscular strength, muscular endurance, agility and aerobic endurance. These physical fitness components included in the test are evaluated with different tests.
6-minute Walk Test 3 months The 6-Minute Walk Test (6-MWT) will be used to assess the submaximal functional capacity of the participants. The aim of the 6-Minute Walk Test is to walk the longest distance possible in a 30-meter corridor in 6 minutes. The 6-MWT will be performed in accordance with the guidelines reported by the American Thoracic Society.
Behavioral Rating Inventory Of Executive Function (BRIEF) 3 months The Behavioral Rating Inventory of Executive Function (BRIEF) is a 3-point Likert-type scale with 86 statements indicating specific behaviors. The statements are scored as '1', '2', '3', respectively. A high score indicates a high level of executive dysfunction.
- Secondary Outcome Measures
Name Time Method Timed Up and Go Test 3 months The Timed Up and Go Test (TUG) will be used to assess participants' functional capacity, balance and walking speed. In the TUG, the participant is asked to get up from a chair with a seat height of approximately 46 cm, walk 3 meters, turn around and sit back down in the chair. The time it takes the patient to complete this activity gives the result of the test.
Anthropometric Measurement - Body Mass Index 3 months For anthropometric measurement, participants; weight (in kilograms) and height (in meters) will be measured and recorded to calculate body mass index (kg/m\^2).
Anthropometric Skinfold Measurement 3 months Total body fat ratio will be obtained by measuring the skin fold in the triceps and subscapular anatomical regions with a special caliper called skinfold. To determine the visceral fat ratio, participants waist and hip circumferences will be measured and recorded.
The Pediatric Quality of Life Inventory 3 months The Pediatric Quality of Life Inventory has child and parent forms, each consisting of 23 items, and each item is scored between 0-100. The child/adolescent is asked to mark the most appropriate option for each sentence, and the parent is asked to mark the most appropriate option for their child. A five-choice Likert-type response scale is used throughout the scale. The higher the total score from the scale, the higher the quality of life.
Godin Leisure-Time Exercise Questionnaire 3 months Godin Leisure-Time Exercise Questionnaire will be administered to participants weekly for 10 weeks to assess and monitor their physical activity levels. In this assessment, a score of 24 and above will be classified as "active", a score between 14 and 23 will be classified as "moderately active", and a score of 13 and below will be classified as "not sufficiently active".
Physical Activity Enjoyment Scale 3 months Physical Activity Enjoyment Scale will be used to assess positive emotions such as pleasure and enjoyment expected from physical activities. Participants are asked to indicate the extent to which they agree with each item, using a seven-point scale ranging from 1-strongly disagree to 7-strongly agree. A high average score from the scale indicates a high level of enjoyment from physical activities.
Trial Locations
- Locations (1)
Bezmialem Vakıf University
🇹🇷İstanbul, Eyüpsultan, Turkey