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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

NCT ID: NCT06617637

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-11-01

Brief Summary

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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

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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.

Conditions

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

Keywords

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Down Syndrome Aerobic exercise Virtual reality Exergame Physical Fitness Functional Capacity Cognitive function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Aerobic-Based Virtual Reality Exercise Training Group

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.

Group Type EXPERIMENTAL

Aerobic Based Virtual Reality Exercise Training

Intervention Type OTHER

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.

Traditional Aerobic Exercise Training Group

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

Group Type ACTIVE_COMPARATOR

Traditional Aerobic Exercise Training

Intervention Type OTHER

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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic 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.

Intervention Type OTHER

Traditional 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Alis Kostanoğlu Asoc.Prof.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alis Kostanoğlu, PhD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Elif Durgut, PhD

Role: STUDY_CHAIR

Bezmialem Vakif University

Ayça Arslantürk Yıldırım, MSc

Role: STUDY_CHAIR

Bezmialem Vakif University

Merve Sevinç Gündüz, MSc

Role: STUDY_CHAIR

Bezmialem Vakif University

Gökhan Can Törpü, BPT

Role: STUDY_CHAIR

Bezmialem Vakif University

Abdurrahman Cahit Örengül, PhD

Role: STUDY_CHAIR

Istanbul University

Locations

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Bezmialem Vakıf University

Istanbul, Eyüpsultan, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Alis Kostanoğlu, PhD

Role: CONTACT

Phone: 5434931848

Email: [email protected]

Elif Durgut, PhD

Role: CONTACT

Phone: 5445706632

Email: [email protected]

Facility Contacts

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Alis Kostanoğlu, PhD

Role: primary

Elif Durgut, PhD

Role: backup

Alis Kostanoğlu, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32029743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34511385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33218550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28585394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30725064 (View on PubMed)

Other Identifiers

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24/09/2024 - BezmialemVU

Identifier Type: -

Identifier Source: org_study_id