AutismNCT05458466
The Effect of Pilates on Muscle Strength, Balance Performance, Gross Motor Skills, Social Skills in Children With ASD
A study testing Pilates training in people with Autism, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this randomized controlled study was to determine the effects of Pilates Training by comparing the effects of Aerobic Training on muscle strength, balance performance, gross motor skills and social skills in children with autism. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- Pilates training
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2021to 13 Sep 2021
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being diagnosed with autism,
- Not having physical disabilities or neurological disorders,
- Having the ability to follow the instructions given during evaluations and training,
- Having the ability to perform the requested training
Who cannot join
- Not being a volunteer,
- Having a health problem that prevents exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pilates Training on Muscle Strength, Balance Performance, Gross Motor Skills and Social Skills in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Trial
The purpose of this randomized controlled study was to determine the effects of Pilates Training by comparing the effects of Aerobic Training on muscle strength, balance performance, gross motor skills and social skills in children with autism.
As a result of this study Aerobic Training and Pilates Training are both effective in the improvement of balance performance and gross motor skills in children with autism, with more improvement in muscle strength in Aerobic Training. Pilates Training could be considered as an alternative training to increase physical activity in children with autism.
Read the detailed description
The purpose of this randomized controlled study was to determine the effects of Pilates Training by comparing the effects of Aerobic Training on muscle strength, balance performance, gross motor skills and social skills in children with autism.
As a result of this study Aerobic Training and Pilates Training are both effective in the improvement of balance performance and gross motor skills in children with autism, with more improvement in muscle strength in Aerobic Training. Pilates Training could be considered as an alternative training to increase physical activity in children with autism.
This study will answer whether pilates practice has an effect on Muscle Strength, Balance Performance, Gross Motor Skills and Social Skills in Children With Autism.
Demographic information of the participants was recorded.Muscle strength for shoulder flexors, hip flexors and knee extensors were performed with Hand-held dynamometry.The one-legged standing test was used to evaluate static balance performance.Test of Gross Motor Development (TGMT-2) was used to evaluate gross motor skills of participants. The Autism Social Skills Profile Turkish Form (ASSP- T) was used to evaluate social skills of participants.
- Conditions
- Autism
- Being tested
- Pilates training
- Keywords
- Autism, Pilates training, Aerobic training, Gross motor skills, Muscle strength, Social skills
- Medical subject headings
- Autistic Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates trainingOther
Also called Aerobic Training
Eighteen children with autism did not meet the inclusion criteria, ten children did not want to participate in the study, and five children were not included in the study due to different reasons. A total of 22 children between the age of 7 and 12 years were participated in this study. The inclusion criteria were (i) being diagnosed with autism, (ii) not having physical disabilities or neurological disorders, (iii) having the ability to follow the instructions given during evaluations and training, and (iv) having the ability to perform the requested training. All parents of participants signed an informed consent form for participation. were divided into two groups including Aerobic Training (n=11) and Pilates Training (n=11) groups by simple randomization method (internet-based). Since one child in the experimental group did not continue Pilates Training, the study was completed with the participation of 21 children with autism.
| Study group | Role | What they receive |
|---|---|---|
| Pilates training Group | Experimental | The Pilates Training program consisted of warm-up, work-out and cool-down sections. For the warm-up section, breathing, standing roll down, and spine twist exercises were selected; for the work-out section, the hundred, shoulder bridge, scissors, swimming, and quadruped exercises, and for cool-down section, torso twist, cat-camel, and standing stretches. The Pilates Training progression was achieved by increasing the number of repetitions of the selected exercises and adding some equipment (balls, foam rollers) to challenge postural stability. In the first five sessions, after each exercise was performed for six to eight repetitions, the number of repetitions was increased to 10-12. Moreover, the environment where the training took place was carefully arranged according to the needs of children with autism. Receives: Other: Pilates training |
| Aerobic Training Group | Experimental | Each training session consisted of a 20-minutes treadmill workout (using the motorized Ultıma Ac 3500 treadmill) followed by 20-minutes bicycle workout (Voit Yellow Collection 112u exercie bike). The intensity of training, which began at 50% to 60% of maximum heart rate (HR), was increased each week so that by week five, the children were at 75% to 80% maximum HR. The maximum HR, as recommended for children, was calculated using the formula 208 - 0.7 x (age) (Mahon et al., 2010). To ensure that the exercise intensity remained in the target HR zone during training, the child's HR was continuously monitored from the used treadmill and exercise bike monitors. Receives: Other: Pilates training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Evaluations of maximal isometric muscle strength for shoulder flexors, hip flexors and knee extensors were performed with Hand-held dynamometry (Jtech Commander PowerTrack II Muscle Tester). Participants were asked to apply the maximum voluntary force they could exert under certain test conditions. Each test procedure for each muscle groups was repeated 3 times, and the best score was used for analysis. The results were recorded for both the right and left side.
Measured: immediately after application
Balance
The one-legged standing test was used to evaluate static balance performance. The participants were asked to maintain a one-legged stance for as long as they can with their eyes open and arms at the side of the trunk. The time recorded in seconds from the moment a foot is lifted off the ground to the moment it touches the ground. The test was performed for right and left side. The participants performed 3 trials, and the longest time was used for analysis
Measured: immediately after application
Gross Motor Skills
The test has two sub-test including locomotor skills tasks such as hopping, sliding, galloping, jumping, running, and the object control skills consists of striking and kicking a stationary ball, dribbling, catching, overhand throwing and underhand rolling. The locomotor skills focus on coordinated movements, while object control skills focus on the child's ability to play with or manipulate balls
Measured: immediately after application
Social Skills
The Autism Social Skills Profile Turkish Form (ASSP- T) was used to evaluate social skills of participants. The test consists of items related to social participation and socially inappropriate behaviors that lead to negative peer relationships. Higher score indicates proficiency in social functions, and lower score indicates inadequacy in social functions
Measured: immediately after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start11 Mar 2021
- Primary completion13 Sep 2021
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazan Ozturk, Aydin Adnan Menderes University
- Investigators
- Nazan Ozturk, PhD., Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458466
- Sponsor's protocol ID
- Alinazan
- Status last verified
- Jul 2022
- First submitted
- 19 Mar 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pilates Training on Muscle Strength, Balance Performance, Gross Motor Skills and Social Skills in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05458466
- Acronym / sponsor ID
- Alinazan
- Conditions
- Autism
- Keywords
- Autism, Pilates training, Aerobic training, Gross motor skills, Muscle strength, Social skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 14 Jul 2022 (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.
The purpose of this randomized controlled study was to determine the effects of Pilates Training by comparing the effects of Aerobic Training on muscle strength, balance performance, gross motor skills and social skills in children with autism.
As a result of this study Aerobic Training and Pilates Training are both effective in the improvement of balance performance and gross motor skills in children with autism, with more improvement in muscle strength in Aerobic Training. Pilates Training could be considered as an alternative training to increase physical activity in children with autism.
Detailed description
The purpose of this randomized controlled study was to determine the effects of Pilates Training by comparing the effects of Aerobic Training on muscle strength, balance performance, gross motor skills and social skills in children with autism.
As a result of this study Aerobic Training and Pilates Training are both effective in the improvement of balance performance and gross motor skills in children with autism, with more improvement in muscle strength in Aerobic Training. Pilates Training could be considered as an alternative training to increase physical activity in children with autism.
This study will answer whether pilates practice has an effect on Muscle Strength, Balance Performance, Gross Motor Skills and Social Skills in Children With Autism.
Demographic information of the participants was recorded.Muscle strength for shoulder flexors, hip flexors and knee extensors were performed with Hand-held dynamometry.The one-legged standing test was used to evaluate static balance performance.Test of Gross Motor Development (TGMT-2) was used to evaluate gross motor skills of participants. The Autism Social Skills Profile Turkish Form (ASSP- T) was used to evaluate social skills of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates training Group | Experimental | Other: Pilates trainingThe Pilates Training program consisted of warm-up, work-out and cool-down sections. For the warm-up section, breathing, standing roll down, and spine twist exercises were selected; for the work-out section, the hundred, shoulder bridge, scissors, swimming, and quadruped exercises, and for cool-down section, torso twist, cat-camel, and standing stretches. The Pilates Training progression was achieved by increasing the number of repetitions of the selected exercises and adding some equipment (balls, foam rollers) to challenge postural stability. In the first five sessions, after each exercise was performed for six to eight repetitions, the number of repetitions was increased to 10-12. Moreover, the environment where the training took place was carefully arranged according to the needs of children with autism. |
| Aerobic Training Group | Experimental | Other: Pilates trainingEach training session consisted of a 20-minutes treadmill workout (using the motorized Ultıma Ac 3500 treadmill) followed by 20-minutes bicycle workout (Voit Yellow Collection 112u exercie bike). The intensity of training, which began at 50% to 60% of maximum heart rate (HR), was increased each week so that by week five, the children were at 75% to 80% maximum HR. The maximum HR, as recommended for children, was calculated using the formula 208 - 0.7 x (age) (Mahon et al., 2010). To ensure that the exercise intensity remained in the target HR zone during training, the child's HR was continuously monitored from the used treadmill and exercise bike monitors. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being diagnosed with autism,
- Not having physical disabilities or neurological disorders,
- Having the ability to follow the instructions given during evaluations and training,
- Having the ability to perform the requested training
Key exclusion criteria (2 listed)
- Not being a volunteer,
- Having a health problem that prevents exercise.
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 |
|---|---|---|
| Pilates trainingAlso: Aerobic TrainingEighteen children with autism did not meet the inclusion criteria, ten children did not want to participate in the study, and five children were not included in the study due to different reasons. A total of 22 children between the age of 7 and 12 years were participated in this study. The inclusion criteria were (i) being diagnosed with autism, (ii) not having physical disabilities or neurological disorders, (iii) having the ability to follow the instructions given during evaluations and training, and (iv) having the ability to perform the requested training. All parents of participants signed an informed consent form for participation. were divided into two groups including Aerobic Training (n=11) and Pilates Training (n=11) groups by simple randomization method (internet-based). Since one child in the experimental group did not continue Pilates Training, the study was completed with the participation of 21 children with autism. | Other | Aerobic Training Group, Pilates training Group |
Primary outcome
Muscle Strength
Time frame: immediately after application
Evaluations of maximal isometric muscle strength for shoulder flexors, hip flexors and knee extensors were performed with Hand-held dynamometry (Jtech Commander PowerTrack II Muscle Tester). Participants were asked to apply the maximum voluntary force they could exert under certain test conditions. Each test procedure for each muscle groups was repeated 3 times, and the best score was used for analysis. The results were recorded for both the right and left side.
Balance
Time frame: immediately after application
The one-legged standing test was used to evaluate static balance performance. The participants were asked to maintain a one-legged stance for as long as they can with their eyes open and arms at the side of the trunk. The time recorded in seconds from the moment a foot is lifted off the ground to the moment it touches the ground. The test was performed for right and left side. The participants performed 3 trials, and the longest time was used for analysis
Gross Motor Skills
Time frame: immediately after application
The test has two sub-test including locomotor skills tasks such as hopping, sliding, galloping, jumping, running, and the object control skills consists of striking and kicking a stationary ball, dribbling, catching, overhand throwing and underhand rolling. The locomotor skills focus on coordinated movements, while object control skills focus on the child's ability to play with or manipulate balls
Social Skills
Time frame: immediately after application
The Autism Social Skills Profile Turkish Form (ASSP- T) was used to evaluate social skills of participants. The test consists of items related to social participation and socially inappropriate behaviors that lead to negative peer relationships. Higher score indicates proficiency in social functions, and lower score indicates inadequacy in social functions
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 14 Jul 2022.
- 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.
Nazan Ozturk, PhD. principal investigator
Aydin Adnan Menderes 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 Pilates training in people with Autism, run by Aydin Adnan Menderes 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 4 inclusion and 2 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 14 Jul 2022. 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?
Muscle Strength (time frame: immediately after application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2022.