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Effectiveness of Aerobic Exercises on the Autistic Children

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic Exercise
Ball Exercises
Sponsored by
University of Faisalabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring Autism spectrum disorder, Physical therapy, Stereotypic behaviors, ASD, Repetitive behaviors, Aerobic exercises, Jogging, Ball exercises.

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed children of autism spectrum disorder (ASD) by experts
  2. Have recognized stereotypic behaviors
  3. Age 6 to 20 years
  4. Independent to walk
  5. Both genders
  6. Parent and teachers willing to give consent

Exclusion Criteria:

  1. Unable to understand commands
  2. Have co-morbidities like schizophrenia or ADHD
  3. Having respiratory or cardiovascular problems
  4. Severe ASD
  5. Lower limb injury and disability

Sites / Locations

  • University of Faisalabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Active control Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2021
Last Updated
October 4, 2021
Sponsor
University of Faisalabad
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1. Study Identification

Unique Protocol Identification Number
NCT05067361
Brief Title
Effectiveness of Aerobic Exercises on the Autistic Children
Official Title
Effectiveness of Aerobic Exercises on the Stereotypic Behaviors and Task Performance of Autistic Children: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
August 8, 2020 (Actual)
Study Completion Date
October 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Faisalabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism spectrum disorder, Physical therapy, Stereotypic behaviors, ASD, Repetitive behaviors, Aerobic exercises, Jogging, Ball exercises.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Title
Active control Group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Aerobic Exercise
Intervention Description
Jogging was performed for 20 minutes. Jogging was performed by experimental group for 3 weeks and 4 sessions per week.
Intervention Type
Procedure
Intervention Name(s)
Ball Exercises
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Repetitive behavior scale revised (RBS-R)
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Jebsen Hand Function Test (JHFT)
Description
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
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Unable to understand commands Have co-morbidities like schizophrenia or ADHD Having respiratory or cardiovascular problems Severe ASD Lower limb injury and disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Sidra Majeed;PT, MSPP
Organizational Affiliation
University of Faisalabad
Official's Role
Study Director
Facility Information:
Facility Name
University of Faisalabad
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Aerobic Exercises on the Autistic Children

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