Clinical trial NCT06617637: 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
Official title: Comparison of the Effects of Aerobic-Based Virtual Reality Exercise Training (Exergame) and Traditional Aerobic Exercise Training on Physical Fitness, Functional Capacity and Cognitive Function in Individuals with Down Syndrome: (DOWNFIT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Down Syndrome
Aerobic Exercise
Virtual Reality Based Therapy
Exergame
Physical Fitness
Functional Capacity
Cognitive Function
Keywords: Down Syndrome
Aerobic exercise
Virtual reality
Exergame
Physical Fitness
Functional Capacity
Cognitive function
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-09-27
Enrollment: 44
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eurofit Fitness Test Battery
timeFrame: 3 months
measure: 6-minute Walk Test
timeFrame: 3 months
measure: Behavioral Rating Inventory Of Executive Function (BRIEF)
timeFrame: 3 months
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: 3 months
measure: Anthropometric Measurement - Body Mass Index
timeFrame: 3 months
measure: Anthropometric Skinfold Measurement
timeFrame: 3 months
measure: The Pediatric Quality of Life Inventory
timeFrame: 3 months
measure: Godin Leisure-Time Exercise Questionnaire
timeFrame: 3 months
measure: Physical Activity Enjoyment Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakıf University
state: Eyüpsultan
Study officials:
affiliation: Bezmialem Vakif University
name: Alis Kostanoğlu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Elif Durgut, PhD
role: STUDY_CHAIR
affiliation: Bezmialem Vakif University
name: Ayça Arslantürk Yıldırım, MSc
role: STUDY_CHAIR
affiliation: Bezmialem Vakif University
name: Merve Sevinç Gündüz, MSc
role: STUDY_CHAIR
affiliation: Bezmialem Vakif University
name: Gökhan Can Törpü, BPT
role: STUDY_CHAIR
affiliation: Istanbul University
name: Abdurrahman Cahit Örengül, PhD
role: STUDY_CHAIR
References:
citation: Antonarakis SE, Skotko BG, Rafii MS, Strydom A, Pape SE, Bianchi DW, Sherman SL, Reeves RH. Down syndrome. Nat Rev Dis Primers. 2020 Feb 6;6(1):9. doi: 10.1038/s41572-019-0143-7.
citation: Shields N. Physiotherapy management of Down syndrome. J Physiother. 2021 Oct;67(4):243-251. doi: 10.1016/j.jphys.2021.08.016. Epub 2021 Sep 10. No abstract available.
citation: Lopes JBP, Duarte NAC, Lazzari RD, Oliveira CS. Virtual reality in the rehabilitation process for individuals with cerebral palsy and Down syndrome: A systematic review. J Bodyw Mov Ther. 2020 Oct;24(4):479-483. doi: 10.1016/j.jbmt.2018.06.006. Epub 2018 Jun 28.
citation: Silva V, Campos C, Sa A, Cavadas M, Pinto J, Simoes P, Machado S, Murillo-Rodriguez E, Barbosa-Rocha N. Wii-based exercise program to improve physical fitness, motor proficiency and functional mobility in adults with Down syndrome. J Intellect Disabil Res. 2017 Aug;61(8):755-765. doi: 10.1111/jir.12384. Epub 2017 Jun 6.
citation: Gomez Alvarez N, Venegas Mortecinos A, Zapata Rodriguez V, Lopez Fontanilla M, Maudier Vasquez M, Pavez-Adasme G, Hemandez-Mosqueira C. [Effect of an intervention based on virtual reality on motor development and postural control in children with Down Syndrome]. Rev Chil Pediatr. 2018 Dec;89(6):747-752. doi: 10.4067/S0370-41062018005001202. Spanish.