Autism Spectrum DisorderNCT05067361
Effectiveness of Aerobic Exercises on the Autistic Children
A study testing Aerobic Exercise and Ball Exercises in people with Autism Spectrum Disorder, run by University of Faisalabad at 1 site in Pakistan.
Trial summary
Autism spectrum disorder (ASD) is a neurodevelopmental disorder manifesting stereotypic behaviors and problem in communication and social interaction. Different physical therapy interventions like aerobics help to improve recurrent behaviors and task performance of autistic children. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Aerobic Exercise and Ball Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Mar 2020to 26 Oct 2020
- 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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed children of autism spectrum disorder (ASD) by experts
- Have recognized stereotypic behaviors
- Age 6 to 20 years
- Independent to walk
- Both genders
- Parent and teachers willing to give consent
Who cannot join
- Unable to understand commands
- Have co-morbidities like schizophrenia or ADHD
- Having respiratory or cardiovascular problems
- Severe ASD
- Lower limb injury and disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Aerobic Exercises on the Stereotypic Behaviors and Task Performance of Autistic Children: A Randomized Clinical Trial
Autism spectrum disorder (ASD) is a neurodevelopmental disorder manifesting stereotypic behaviors and problem in communication and social interaction. Different physical therapy interventions like aerobics help to improve recurrent behaviors and task performance of autistic children. This study was focused to see the effect of jogging on the stereotypic behaviors and task performance of autistic children. A single blinded randomized study was conducted on 38 autistic children, randomly allocated to two groups, performing jogging and ball exercises. Repetitive Behavior Scale-revised(RBS-R) and Jebsen Hand Function Test (JHFT) was used for assessment. Exercise was performed for 3 weeks and 4 sessions per week.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Aerobic Exercise, Ball Exercises
- Keywords
- Autism spectrum disorder, Physical therapy, Stereotypic behaviors, ASD, Repetitive behaviors, Aerobic exercises, Jogging, Ball exercises.
- Medical subject headings
- Autism Spectrum Disorder, Stereotypic Movement Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseProcedure or surgery
Jogging was performed for 20 minutes. Jogging was performed by experimental group for 3 weeks and 4 sessions per week.
Ball ExercisesProcedure or surgery
Ball exercises like stability ball roll, stability ball hug, stability ball catching, ball throwing and ball tapping exercises were for 10 minutes. Ball exercises was performed by both groups for 3 weeks and 4 times per week .
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Procedure: Aerobic Exercise; Procedure: Ball Exercises |
| Active control Group | Active comparator | Not described Receives: Procedure: Ball Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repetitive behavior scale revised (RBS-R)
RBS-R was used to assess the stereotypic behaviors of autistic children. It is 43 items questionnaire that is placed under six subscales. The sub-scales are Stereotyped Behavior Subscale Self-Injurious Behavior Subscale Compulsive Behavior Subscale Ritualistic Behavior Subscale Sameness Behavior Subscale Restricted Behavior Subscale Each subscale has different characteristics, which are classified from 0 to 3 (behavior is severe). Moreover, each behavior is also rated that how much this behavior occurs, cause interruption in activity and how much a child become agitated when he was interrupted. Global score rating was used by calculating the scores of all the six subscales and total score was given in range of 1 to 100.
Measured: 3 weeks
Secondary outcomes (1)
Jebsen Hand Function Test (JHFT)
JHFT was used to evaluate the task performance of autistic children.JHFT has seven variants and time was recorded, in seconds, taken by children to complete these seven tasks. These seven tasks are writing, card turning, small common objects, simulated feeding, stacking, lifting large lightweight objects and lifting large heavy objects. These piece of work was first performed by the non-dominant hand then by the dominant hand and at the end time required during all the task was summed up in minutes
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start3 Mar 2020
- Primary completion8 Aug 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Amna Ayub PT, University of Faisalabad
- Investigators
- Dr Sidra Majeed;PT, MSPP, Study director, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067361
- Sponsor's protocol ID
- TUF/DR/MSPP/173
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aerobic Exercises on the Stereotypic Behaviors and Task Performance of Autistic Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05067361
- Acronym / sponsor ID
- TUF/DR/MSPP/173
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, Physical therapy, Stereotypic behaviors, ASD, Repetitive behaviors, Aerobic exercises, Jogging, Ball exercises.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 8 Aug 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 5 Oct 2021 (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.
Autism spectrum disorder (ASD) is a neurodevelopmental disorder manifesting stereotypic behaviors and problem in communication and social interaction. Different physical therapy interventions like aerobics help to improve recurrent behaviors and task performance of autistic children. This study was focused to see the effect of jogging on the stereotypic behaviors and task performance of autistic children. A single blinded randomized study was conducted on 38 autistic children, randomly allocated to two groups, performing jogging and ball exercises. Repetitive Behavior Scale-revised(RBS-R) and Jebsen Hand Function Test (JHFT) was used for assessment. Exercise was performed for 3 weeks and 4 sessions per week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Aerobic Exercise, Procedure: Ball Exercises |
| Active control Group | Active comparator | Procedure: Ball Exercises |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosed children of autism spectrum disorder (ASD) by experts
- Have recognized stereotypic behaviors
- Age 6 to 20 years
- Independent to walk
- Both genders
Key exclusion criteria (5 listed)
- Unable to understand commands
- Have co-morbidities like schizophrenia or ADHD
- Having respiratory or cardiovascular problems
- Severe ASD
- Lower limb injury and disability
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 ExerciseJogging was performed for 20 minutes. Jogging was performed by experimental group for 3 weeks and 4 sessions per week. | Procedure or surgery | Experimental Group |
| Ball ExercisesBall exercises like stability ball roll, stability ball hug, stability ball catching, ball throwing and ball tapping exercises were for 10 minutes. Ball exercises was performed by both groups for 3 weeks and 4 times per week . | Procedure or surgery | Active control Group, Experimental Group |
Primary outcome
Repetitive behavior scale revised (RBS-R)
Time frame: 3 weeks
RBS-R was used to assess the stereotypic behaviors of autistic children. It is 43 items questionnaire that is placed under six subscales. The sub-scales are Stereotyped Behavior Subscale Self-Injurious Behavior Subscale Compulsive Behavior Subscale Ritualistic Behavior Subscale Sameness Behavior Subscale Restricted Behavior Subscale Each subscale has different characteristics, which are classified from 0 to 3 (behavior is severe). Moreover, each behavior is also rated that how much this behavior occurs, cause interruption in activity and how much a child become agitated when he was interrupted. Global score rating was used by calculating the scores of all the six subscales and total score was given in range of 1 to 100.
1 secondary outcome
Jebsen Hand Function Test (JHFT)
Time frame: 3 weeks
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 5 Oct 2021.
- 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.
Dr Sidra Majeed;PT, MSPP study director
University of Faisalabad
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 Exercise and Ball Exercises in people with Autism Spectrum Disorder, run by University of Faisalabad at 1 site in Pakistan.
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 6 inclusion and 5 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 5 Oct 2021. 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 Pakistan. 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?
Repetitive behavior scale revised (RBS-R) (time frame: 3 weeks). 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 5 Oct 2021.