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

Bezmialem Vakif University

Status: Not yet enrolling

Conditions: Physical Fitness; Aerobic Exercise; Cognitive Function; Functional Capacity; Down Syndrome; Virtual Reality Based Therapy; Exergame

Treatments: Other: Traditional Aerobic Exercise Training; Other: Aerobic Based Virtual Reality Exercise Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06617637

24/09/2024 - BezmialemVU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

44 participants in 3 patient groups

Aerobic-Based Virtual Reality Exercise Training Group

Experimental group

Description:

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.

Treatment:

Other: Aerobic Based Virtual Reality Exercise Training

Traditional Aerobic Exercise Training Group

Active Comparator group

Description:

The traditional aerobic exercise group will receive treadmill training under the supervision of a physiotherapist 2 days a week for 10 weeks.

Treatment:

Other: Traditional Aerobic Exercise Training

Control Group

No Intervention group

Description:

Participants in the control group will be advised to continue with their standard daily living activities.