NCT05458466

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

March 19, 2022

Last Update Submit

July 12, 2022

Conditions

Keywords

AutismPilates trainingAerobic trainingGross motor skillsMuscle strengthSocial skills

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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

    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

    immediately after application

Study Arms (2)

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.

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.

Other: Pilates training

Interventions

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.

Also known as: Aerobic Training
Aerobic Training GroupPilates training Group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Not being a volunteer,
  • Having a health problem that prevents exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydin Efeler Autism Sports Center

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autistic DisorderSocial Skills

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Nazan Ozturk, PhD.

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Lecturer, Physiotherapist

Study Record Dates

First Submitted

March 19, 2022

First Posted

July 14, 2022

Study Start

March 11, 2021

Primary Completion

September 13, 2021

Study Completion

September 13, 2021

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations