Down SyndromeNCT06617637
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
A study testing Aerobic Based Virtual Reality Exercise Training and Traditional Aerobic Exercise Training in people with Down Syndrome and Aerobic Exercise, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Down Syndrome, Aerobic Exercise, Virtual Reality Based Therapy
- What is being tested?
- Aerobic Based Virtual Reality Exercise Training and Traditional Aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, Eyüpsultan, 34000
About this study
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)
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.
Read the 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.
- Conditions
- Down Syndrome, Aerobic Exercise, Virtual Reality Based Therapy, Exergame, Physical Fitness, Functional Capacity
- Being tested
- Aerobic Based Virtual Reality Exercise Training, Traditional Aerobic Exercise Training
- Keywords
- Down Syndrome, Aerobic exercise, Virtual reality, Exergame, Physical Fitness, Functional Capacity, Cognitive function
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Based Virtual Reality Exercise TrainingOther
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 TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (6)
Timed Up and Go Test
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.
Measured: 3 months
Anthropometric Measurement - Body Mass Index
For anthropometric measurement, participants; weight (in kilograms) and height (in meters) will be measured and recorded to calculate body mass index (kg/m^2).
Measured: 3 months
Anthropometric Skinfold Measurement
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.
Measured: 3 months
The Pediatric Quality of Life Inventory
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.
Measured: 3 months
Godin Leisure-Time Exercise Questionnaire
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".
Measured: 3 months
Physical Activity Enjoyment Scale
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Alis Kostanoğlu Asoc.Prof., Bezmialem Vakif University
- Investigators
- Alis Kostanoğlu, PhD, Principal investigator, Bezmialem Vakif UniversityElif Durgut, PhD, Study chair, Bezmialem Vakif UniversityAyça Arslantürk Yıldırım, MSc, Study chair, Bezmialem Vakif UniversityMerve Sevinç Gündüz, MSc, Study chair, Bezmialem Vakif UniversityGökhan Can Törpü, BPT, Study chair, Bezmialem Vakif UniversityAbdurrahman Cahit Örengül, PhD, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617637
- Sponsor's protocol ID
- 24/09/2024 - BezmialemVU
- Status last verified
- May 2026
- First submitted
- 24 Sep 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32029743Shields 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.
PubMed 34511385Lopes 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.
PubMed 33218550Silva 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.
PubMed 28585394Gomez 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.
PubMed 30725064
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06617637
- Acronym / sponsor ID
- 24/09/2024 - BezmialemVU
- Conditions
- Down Syndrome, Aerobic Exercise, Virtual Reality Based Therapy, Exergame, Physical Fitness, Functional Capacity
- Keywords
- Down Syndrome, Aerobic exercise, Virtual reality, Exergame, Physical Fitness, Functional Capacity, Cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic-Based Virtual Reality Exercise Training Group | Experimental | Other: Aerobic Based Virtual Reality Exercise TrainingAerobic 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. |
| Traditional Aerobic Exercise Training Group | Active comparator | Other: Traditional Aerobic Exercise TrainingThe traditional aerobic exercise group will receive treadmill training under the supervision of a physiotherapist 2 days a week for 10 weeks. |
| Control Group | No intervention | –Participants in the control group will be advised to continue with their standard daily living activities. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Based Virtual Reality Exercise TrainingWith 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. | Other | Aerobic-Based Virtual Reality Exercise Training Group |
| Traditional Aerobic Exercise TrainingUsing 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. | Other | Traditional Aerobic Exercise Training Group |
Primary outcome
Eurofit Fitness Test Battery
Time frame: 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
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Timed Up and Go Test
Time frame: 3 months
Anthropometric Measurement - Body Mass Index
Time frame: 3 months
Anthropometric Skinfold Measurement
Time frame: 3 months
The Pediatric Quality of Life Inventory
Time frame: 3 months
Godin Leisure-Time Exercise Questionnaire
Time frame: 3 months
Physical Activity Enjoyment Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 32029743Antonarakis 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.
- Background: PubMed 34511385Shields 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.
- Background: PubMed 33218550Lopes 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.
- Background: PubMed 28585394Silva 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.
- Background: PubMed 30725064Gomez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alis Kostanoğlu, PhD principal investigator
Bezmialem Vakif University
Elif Durgut, PhD study chair
Bezmialem Vakif University
Ayça Arslantürk Yıldırım, MSc study chair
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Based Virtual Reality Exercise Training and Traditional Aerobic Exercise Training in people with Down Syndrome and Aerobic Exercise, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eurofit Fitness Test Battery (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06617637, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.