NCT07068659

Brief Summary

Autism Spectrum Disorder (ASD) is a developmental condition that impacts a child's ability to communicate and interact socially, often accompanied by repetitive behaviors and unique patterns of activity. In addition to these core characteristics, children with ASD frequently exhibit lower levels of physical fitness and are at risk for a range of health concerns, including compromised cardiovascular health and reduced respiratory function. These physical limitations can contribute to broader health disparities and reduced quality of life. Regular physical activity is increasingly recognized as an important element in managing these challenges, offering benefits that extend beyond physical health to improve social skills, behavior, and overall well-being. However, understanding which types of physical activity can most effectively enhance cardiorespiratory fitness and respiratory performance in children with ASD remains a developing field. Examining the effects of structured exercise programs, such as circuit training, can provide valuable insights into optimizing fitness strategies that cater to the unique needs of children on the autism spectrum. The objective of study is to determine the effects of circuit aerobic training and circuit resistance training on cardiorespiratory fitness, cardiovascular responses, and peak expiratory flow rate in Autistic spectrum disorder children It is a randomized clinical trial. A consecutive sampling technique will be used to recruit the ASD children for the study. Then, they will be divided into two groups by simple random sampling through sealed opaque enveloped. Hand Grip Exercise will be given as baseline treatment. In group A patients will be given with circuit aerobic training while in group B patients will be given with circuit resistance training. The 6-minute walk test will be used to assess cardiorespiratory fitness (VO2 max), peak expiratory flow meter will be used to check peak expiratory flow rate (PEFR), and digital sphygmomanometer will be used to check cardiovascular response. Data will be entered and analyzed through SPSS version 21.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

July 7, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

Autism spectrum disorderCardiorespiratory fitnessPeak expiratory flow rateCircuit Training

Outcome Measures

Primary Outcomes (4)

  • Peak Expiratory Flow Rate

    Peak Expiratory Flow Rate (PEFR) is a lung function test measuring the maximum speed of exhalation (in L/min) using a peak flow meter to assess airway obstruction, primarily for asthma management. Normal readings typically range from 400-700 L/min for adults

    Baseline, Week 3, Week 6

  • Modified Six Minute Walk Test

    The Modified Six-Minute Walk Test (6MWT) is a submaximal exercise test measuring the distance an individual can walk on a flat, hard surface in 6 minutes, commonly used to assess functional capacity in cardiopulmonary patients. While typically performed on a 30-meter course, modifications (e.g., shorter paths) can significantly alter results, reducing distances by up to 77 meters

    Baseline, Week 3, Week 6

  • Systolic Blood Pressure

    Systolic blood pressure, the top number in a reading (e.g., 120/80 mmHg), measures the maximum pressure in your arteries when the heart contracts and pumps blood. A normal reading is less than 120 mmHg, while 130-139 mmHg is Stage 1 hypertension.

    Baseline, Week 3, Week 6

  • Disatolic Blood Pressure

    Diastolic blood pressure (DBP) is the bottom number in a reading, measuring pressure in the arteries when the heart muscle rests between beats. A normal reading is typically less than (e.g., ), with under potentially indicating hypotension. High DBP (\> ) often requires lifestyle adjustments.

    Baseline, Week 3, Week 6

Study Arms (2)

Group A

EXPERIMENTAL

Circuit Aerobic Training

Other: Circuit Aerobic Training

Group B

ACTIVE COMPARATOR

Circuit Resistance Training

Other: Circuit Resistance Training

Interventions

Participant will start with five-minute warm-up consisting of running at a heart rate under 100 beats per minute, followed by stretching for 20 sec. For the 30-minute aerobic portion of the exercise sessions, in weeks 1 - 2, participants will be required to complete two circuits of walking for 5 minutes, stepping up and down on a 30 cm step for 4 minutes, and walking backward and forward for 10 meters for 5 minutes. In weeks 3 - 4, participants will complete two circuits of walking for 4 1/2 minutes, stepping up and down on a 30 cm step for 4 minutes, and walking backward and forward for 10 meters for 5 minutes. In weeks 5 - 6, participants will complete two circuits of walking for 5 minutes, stepping up and down on a 30 cm step for 5 minutes, and walking backward and forward for 10 meters for 5 minutes. The rest interval between the circuits will be 5 minutes and between the sets between 30 seconds. The intensity of the aerobic exercises will be maintained at 9 - 15 on the rating of

Group A

Participant will start with five-minute warm-up consisting of running at a heart rate under 100 beats per minute, followed by stretching for 20 sec. For the 30-minute resistance portion of the exercise sessions, in weeks 1 - 2, participants will be required to complete two circuits of hamstring curl with ankle weight on each leg for 5 minutes, leg raises with ankle weight on each leg for 4 minutes, and modified squats with weights for 5 minutes. In weeks 3 - 4, participants will complete two circuits of hamstring curl with ankle weight on each leg for 4 1/2 minutes, leg raises with ankle weight on each leg for 4 minutes, and modified squats with weights for 5 minutes. In weeks 5 - 6, participants will complete two circuits of hamstring curl with ankle weight on each leg for 5 minutes, leg raises with ankle weight on each leg for 5 minutes, and modified squats with weights for 5 minutes. The rest interval between the circuits will be 5 minutes and between the sets between 30 seconds. Ch

Group B

Eligibility Criteria

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

You may qualify if:

  • Age 7-17
  • Diagnosed Autistic (ASD) Children with 2 gold standard test Autism Diagnostic Observation Schedule (ADOS) and the Autism Diagnostic Interview-Revised .
  • Vineland scale-II completed by parents that assessed three dimensions of adaptive daily behaviors (communication, daily living skills and socialization), and children with average score between 85-115 out of total score 20-160 will be selected

You may not qualify if:

  • Contra-indication against physical exercise (e.g., cardiovascular disease or cardiac insufficiency that might alter heart rate (HR) response)
  • Psychiatric disorders or comorbid medical (e.g., no epilepsy)
  • Severe osteo-articular pathology
  • Respiratory disorders (e.g., asthma)
  • Medical treatment that may alter the metabolic response
  • Cognitive disabilities (IQ \< 70)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • Toscano CVA, Ferreira JP, Quinaud RT, Silva KMN, Carvalho HM, Gaspar JM. Exercise improves the social and behavioral skills of children and adolescent with autism spectrum disorders. Front Psychiatry. 2022 Dec 22;13:1027799. doi: 10.3389/fpsyt.2022.1027799. eCollection 2022.

    PMID: 36620673BACKGROUND
  • Hodges H, Fealko C, Soares N. Autism spectrum disorder: definition, epidemiology, causes, and clinical evaluation. Transl Pediatr. 2020 Feb;9(Suppl 1):S55-S65. doi: 10.21037/tp.2019.09.09.

    PMID: 32206584BACKGROUND
  • Bougeard C, Picarel-Blanchot F, Schmid R, Campbell R, Buitelaar J. Prevalence of Autism Spectrum Disorder and Co-morbidities in Children and Adolescents: A Systematic Literature Review. Front Psychiatry. 2021 Oct 27;12:744709. doi: 10.3389/fpsyt.2021.744709. eCollection 2021.

    PMID: 34777048BACKGROUND

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Danish Hassan, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

May 1, 2025

Primary Completion

November 30, 2025

Study Completion

December 30, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations