Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 3:42 PM
Study NCT ID:
NCT05725733
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2023-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Physical Activity Autonomic Response of Autism Spectrum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single- blinded randomized controlled study design will be used, the exercise program will be administrated for four weeks, three times per week, and sixteen minutes per session. Heart rate, ECG, Measurements of respiration, and blood pressure will be measured three times every session: at rest before starting exercises (baseline), directly after finishing exercises, and 15 minutes after finishing exercises.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-03', 'lastUpdatePostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ECG measurements', 'timeFrame': 'One minute', 'description': 'A wearable device will be used to collet cardiac ECG data.'}, {'measure': 'Measurements of respiration', 'timeFrame': '5 minutes', 'description': 'Portable Respiratory Monitor will be used to measure the respiratory activity.'}, {'measure': 'Blood pressure measurement', 'timeFrame': '5 minutes', 'description': 'Manual sphygmomanometer will be used to measure the blood pressure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurodevelopmental Disorders']}, 'referencesModule': {'references': [{'pmid': '38617566', 'type': 'DERIVED', 'citation': 'Ahmed MM, Alawna M, Youssef ASA, Amin WM, Alajam RA, Morsy WE, Fayed E, Mohamed AA. Immediate effect of physical activity on the autonomic nervous system in individuals with autism spectrum disorders of different age groups: a randomised trial. BMJ Open Sport Exerc Med. 2024 Apr 11;10(2):e001822. doi: 10.1136/bmjsem-2023-001822. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the effect of physical activity on autism spectrum disorder (ASD) in individuals with ASD of different age groups through measuring the hemodynamic, heart activity and respiratory system parameters.', 'detailedDescription': 'One hundred participants will be included in this study. One hundred typically developed children or control group and one hundred children with ASD group. The age range of participants will be 4 - 18 years old. The participants in both control and ASD groups will be randomly divided into 4 subgroups according to their age (4-7 years old, 7-10 years old, 10-13 years old and, 14-18 years old). Also, ASD group will be categorized according to the symptoms severity using the childhood autism rating scale (CARS). Participants will be excluded if they have any intellectual disability (IQ ≤ 70), co-morbid medical or psychiatric disorders, pervasive developmental disorders (PDD) or Attention-deficit hyperactivity disorders (ADHD). They will also be excluded if they are taking any medications which to affect cardiovascular system, respiratory system, or arousal and balance or any other contraindications to exercises. Wechsler Intelligence Scale for Children-Fourth Edition24 will be used to assess the Intelligence Quotient (IQ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children with ASD group with the age range of participants will be 4 - 18 years old\n2. Typically developed children with the age range of participants will be 4 - 18 years old\n\nExclusion Criteria:\n\nParticipants will be excluded if they have the following:\n\n* any intellectual disability (IQ ≤ 70)\n* co-morbid medical or psychiatric disorders.\n* pervasive developmental disorders (PDD) or Attention-deficit hyperactivity disorders (ADHD).\n* They will also be excluded if they are taking any medications which to affect cardiovascular system, respiratory system, or arousal and balance or any other contraindications to exercises.'}, 'identificationModule': {'nctId': 'NCT05725733', 'briefTitle': 'The Effect of Physical Activity Autonomic Response of Autism Spectrum', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University of Jazan'}, 'officialTitle': 'The Effect of Physical Activity on The Response of Autonomic Nervous System in Individuals With Autism Spectrum Disorders of Different Age Groups', 'orgStudyIdInfo': {'id': '2265749561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'children with ASD group.', 'description': 'ASD groups will be randomly divided into 4 subgroups according to their age (4-7 years old, 7-10 years old, 10-13 years old and, 14-18 years old). Also, ASD group will be categorized according to the symptoms severity using the childhood autism rating scale (CARS).', 'interventionNames': ['Other: Physical Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'One hundred typically developed children or control group', 'description': 'They will be randomly divided into 4 subgroups according to their age (4-7 years old, 7-10 years old, 10-13 years old and, 14-18 years old)', 'interventionNames': ['Other: Physical Therapy']}], 'interventions': [{'name': 'Physical Therapy', 'type': 'OTHER', 'otherNames': ['Treadmill walking program'], 'description': 'The participant will walk for 3-minutes at this speed as a warming up period. After these 3-minutes, the speed will be increased gradually up to 5-6 km/minute under the supervision of parents and therapist. The children will perform 10-minute running at this speed. After this, the cooling down exercise will be performed for 3-minutes. The speed will be decreased for 2 km/ minute and gradually stop.', 'armGroupLabels': ['One hundred typically developed children or control group', 'children with ASD group.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45142', 'city': 'Jizan', 'state': 'Gizan', 'country': 'Saudi Arabia', 'facility': 'Jazan University', 'geoPoint': {'lat': 16.88917, 'lon': 42.55111}}], 'overallOfficials': [{'name': 'Mohamed M Ahmed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor, Jazan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jazan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mohammed Moustafa', 'investigatorAffiliation': 'University of Jazan'}}}}