Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:04 AM
Study NCT ID:
NCT07474259
Status:
COMPLETED
Last Update Posted:
2026-03-17
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerobic Exercise Intervention for PTSD Symptoms and Sleep Quality After Earthquake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to either an aerobic exercise intervention group or a control group. The intervention group participated in a supervised moderate-intensity aerobic exercise program conducted twice weekly for three weeks (six sessions in total), while the control group continued their usual daily activities without structured exercise.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Posttraumatic Stress Symptoms', 'timeFrame': 'Baseline and 3 weeks (post-intervention)', 'description': 'Posttraumatic stress symptom severity measured using the PTSD Checklist for DSM-5 (PCL-5). Scores will be compared between baseline and post-intervention to evaluate the effect of the aerobic exercise program.'}], 'secondaryOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': 'Baseline and 3 weeks (post-intervention)', 'description': 'Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aerobic exercise; posttraumatic stress disorder; sleep quality; earthquake survivors; randomized controlled trial'], 'conditions': ['Post-Traumatic Stress Disorder', 'Sleep Disturbance']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Adhikari Baral I,K C B'}, {'type': 'BACKGROUND', 'citation': 'Alnawwar MA,Alraddadi MI,Algethmi RA,Salem GA,Salem MA,Alharbi AA'}, {'pmid': '26606250', 'type': 'BACKGROUND', 'citation': 'Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.'}, {'pmid': '33418432', 'type': 'BACKGROUND', 'citation': 'Chen XY, Shi X, Li Y, Zhou Y, Chen H, Wang T, Fan F. Psychiatric comorbidity predicts sleep disturbances among adolescent earthquake survivors: a 10-year cohort study. Sleep Med. 2021 Feb;78:94-100. doi: 10.1016/j.sleep.2020.12.015. Epub 2020 Dec 21.'}, {'pmid': '2748771', 'type': 'BACKGROUND', 'citation': 'Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.'}, {'pmid': '36436532', 'type': 'BACKGROUND', 'citation': 'Bryant RA, Dawson KS, Azevedo S, Yadav S, Cahill C, Kenny L, Maccallum F, Tran J, Rawson N, Tockar J, Garber B, Keyan D. Augmenting trauma-focused psychotherapy for post-traumatic stress disorder with brief aerobic exercise in Australia: a randomised clinical trial. Lancet Psychiatry. 2023 Jan;10(1):21-29. doi: 10.1016/S2215-0366(22)00368-6. Epub 2022 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to examine the effects of a moderate-intensity aerobic exercise program on post-traumatic stress disorder (PTSD) symptoms and sleep quality among earthquake survivors living in temporary accommodation centers. Participants are randomly assigned to either an exercise intervention group or a control group. The intervention group participates in supervised aerobic exercise sessions twice per week for three weeks. PTSD symptoms and sleep quality are assessed before and after the intervention using validated measurement tools. The study aims to provide evidence on the effectiveness of structured aerobic exercise in improving psychological well-being and sleep quality among individuals affected by natural disasters.', 'detailedDescription': 'Natural disasters such as earthquakes can lead to significant psychological consequences, including post-traumatic stress disorder (PTSD) and sleep disturbances. Individuals who experience earthquakes and continue to live in temporary accommodation conditions may remain exposed to ongoing stressors that negatively affect their mental health and overall well-being.\n\nPhysical activity has been suggested as a potentially beneficial non-pharmacological intervention for improving psychological health and sleep quality. Aerobic exercise in particular has been shown to reduce stress, improve mood, and regulate sleep patterns. However, there is limited evidence regarding the effectiveness of structured aerobic exercise programs for earthquake survivors living in temporary settlement areas.\n\nThis randomized controlled study investigates the effects of a moderate-intensity aerobic exercise program on PTSD symptoms and sleep quality among adult earthquake survivors residing in temporary accommodation centers. Participants who meet the inclusion criteria are randomly assigned to an intervention group or a control group. The intervention group participates in supervised aerobic exercise sessions conducted twice per week for three weeks, resulting in a total of six exercise sessions. The control group continues their routine daily activities without participating in the exercise program.\n\nOutcome measures include PTSD symptom severity and sleep quality assessed before and after the intervention using validated scales. The findings of this study are expected to contribute to the development of evidence-based psychosocial and behavioral interventions aimed at improving mental health outcomes among populations affected by natural disasters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced the February 6, 2023 earthquake\n* Aged between 18 and 65 years\n* Able to read and understand Turkish\n* Provided written informed consent to participate\n\nExclusion Criteria:\n\n* Younger than 18 years or older than 65 years\n* Incomplete or invalid questionnaire responses\n* Insufficient literacy to complete the study instruments\n* History of severe psychiatric diagnosis'}, 'identificationModule': {'nctId': 'NCT07474259', 'acronym': 'EX-PTSD', 'briefTitle': 'Aerobic Exercise Intervention for PTSD Symptoms and Sleep Quality After Earthquake', 'organization': {'class': 'OTHER', 'fullName': 'Malatya Turgut Ozal University'}, 'officialTitle': 'Effects of Aerobic Exercise on PTSD and Sleep: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OZAL-TN-RC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise Group', 'description': 'Participants assigned to this group participated in a structured moderate-intensity aerobic exercise program consisting of six group sessions delivered over three weeks. Each session included warm-up, aerobic exercise activities, and cool-down exercises. The program was designed to improve posttraumatic stress symptoms and sleep quality among earthquake survivors.', 'interventionNames': ['Behavioral: Moderate-Intensity Aerobic Exercise Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in the control group did not receive any structured exercise intervention during the study period and continued their usual daily routines.'}], 'interventions': [{'name': 'Moderate-Intensity Aerobic Exercise Program', 'type': 'BEHAVIORAL', 'description': 'A structured moderate-intensity aerobic exercise program delivered in group sessions over three weeks. The program consisted of six sessions including warm-up exercises, aerobic activity, and cool-down periods. The intervention aimed to reduce posttraumatic stress symptoms and improve sleep quality among earthquake survivors living in temporary accommodation settings.', 'armGroupLabels': ['Aerobic Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44330', 'city': 'Malatya', 'state': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Malatya Turgut Ozal University Training and Research Hospital', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Rana Ceviz, RN, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Malatya Turgut Ozal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to ethical and confidentiality considerations. The dataset contains potentially identifiable information from earthquake survivors residing in temporary accommodation settings, and sharing individual-level data could compromise participant privacy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malatya Turgut Ozal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Rana Ceviz', 'investigatorAffiliation': 'Malatya Turgut Ozal University'}}}}