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

NCT06617637 | Not Yet Recruiting

• 1 other identifier: 24/09/2024 - BezmialemVU
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Eurofit Fitness Test Battery

  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.

  3 months

• 6-minute Walk Test

  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.

  3 months

• Behavioral Rating Inventory Of Executive Function (BRIEF)

  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.

  3 months

Secondary Outcomes (6)

• Timed Up and Go Test

  3 months

• Anthropometric Measurement - Body Mass Index

  3 months

• Anthropometric Skinfold Measurement

  3 months

• The Pediatric Quality of Life Inventory

  3 months

• Godin Leisure-Time Exercise Questionnaire

  3 months

Study Arms (3)

Aerobic-Based Virtual Reality Exercise Training Group

EXPERIMENTAL

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.

Other: Aerobic Based Virtual Reality Exercise Training

Traditional Aerobic Exercise Training Group

ACTIVE COMPARATOR

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

Other: Traditional Aerobic Exercise Training

Control Group

NO INTERVENTION

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

Interventions

Aerobic Based Virtual Reality Exercise Training 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.

Aerobic-Based Virtual Reality Exercise Training Group

Traditional Aerobic Exercise Training 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.

Traditional Aerobic Exercise Training Group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Eyüpsultan, 34000, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 32029743 BACKGROUND

• 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.

  PMID: 34511385 BACKGROUND

• 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.

  PMID: 33218550 BACKGROUND

• 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.

  PMID: 28585394 BACKGROUND

• 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.

  PMID: 30725064 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Alis Kostanoğlu, PhD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

• Elif Durgut, PhD

  Bezmialem Vakif University

  STUDY CHAIR

• Ayça Arslantürk Yıldırım, MSc

  Bezmialem Vakif University

  STUDY CHAIR

• Merve Sevinç Gündüz, MSc

  Bezmialem Vakif University

  STUDY CHAIR

• Gökhan Can Törpü, BPT

  Bezmialem Vakif University

  STUDY CHAIR

• Abdurrahman Cahit Örengül, PhD

  Istanbul University

  STUDY CHAIR

Central Study Contacts

Alis Kostanoğlu, PhD

CONTACT

5434931848; aliskostanoglu@gmail.com

Elif Durgut, PhD

CONTACT

5445706632; edurgut@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)