Aerobic Exercise, Cognitive Function, Down Syndrome, Exergame, Functional Capacity, Physical Fitness, Virtual Reality Based Therapy
Conditions
Keywords
Down Syndrome, Aerobic exercise, Virtual reality, Exergame, Physical Fitness, Functional Capacity, Cognitive function
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.
Interventions
OTHERAerobic Based Virtual Reality Exercise Training
With Aerobic Based Virtual Reality Exercise Training, participants will perform aerobic exercise training with the Xbox Kinect 360 game "Your Shape Fitness Evolved 2012". "Your Shape Fitness Evolved 2012" is a game that requires basic coordination and is designed to improve the fitness levels of individuals. The game is used as an entertaining aerobic training tool that includes many aerobic activities such as boxing, yoga, dancing, etc. with adjustable difficulty levels.
OTHERTraditional Aerobic Exercise Training
Using a treadmill, participants will be put through an exercise training consisting of a 10-minute warm-up at 0 degree incline, a 20-30-minute (by increasing the walking time by 5 minutes at the end of the first four weeks and the beginning of the last four weeks) walking at 40-80% of the heart rate reserve (moderate-vigorous intensity) and a 10-minute cool-down period. Treadmill walking levels will be changed if necessary to ensure the targeted exercise intensity.
Sponsors
Bezmialem Vakif University
The Scientific and Technological Research Council of Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The researchers conducting the evaluations in the study will be masked to the treatment groups, and the researcher conducting the statistical analysis will be masked to the evaluations.
Intervention model description
Participants to be included in the study will be randomly grouped into three groups. Two groups will be the intervention group and one group will be the control group.
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAlis Kostanoğlu, PhD
Bezmialem Vakif University
STUDY_CHAIRElif Durgut, PhD
Bezmialem Vakif University
STUDY_CHAIRAyça Arslantürk Yıldırım, MSc
Bezmialem Vakif University
STUDY_CHAIRMerve Sevinç Gündüz, MSc
Bezmialem Vakif University
STUDY_CHAIRGökhan Can Törpü, BPT
Bezmialem Vakif University
STUDY_CHAIRAbdurrahman Cahit Örengül, PhD
Istanbul University
Outcome results
None listed