Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-29 @ 11:34 PM
Study NCT ID:
NCT06572657
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2024-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of Aerobic Exercise and Computerized Cognitive Stimulation in Patients With Schizophrenia - A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment Scale', 'timeFrame': '12 weeks', 'description': 'MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.'}, {'measure': 'Frontal Assessment Battery', 'timeFrame': '12 weeks', 'description': 'Frontal Assessment Battery consists of six subtests for assessing executive functions; the scale is scored from 0 to 18, with higher scores indicating better frontal functions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Exercise', 'Computerized Cognitive Stimulation']}, 'descriptionModule': {'briefSummary': 'Schizophrenia is a chronic mental disorder characterized by the occurrence of both positive symptoms, such as hallucinations and delusions, and negative symptoms, such as apathy and withdrawal, repetition of cognitive skills and disorganization. There are approximately 20 million people with schizophrenia worldwide and this number will continue to increase every year.', 'detailedDescription': 'The aim of this study was to compare the effects of computer-based cognitive stimulation and aerobic/strengthening exercises on symptom severity, cognition and depression in schizophrenia patients receiving community mental health center services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals diagnosed with schizophrenia by a physician according to DSM-V criteria Patients treated at TRSM Individuals diagnosed with schizophrenia between the ages of 20-60\n\nExclusion Criteria:\n\n* Those who did not give consent to participate in the study Patients with a diagnosis other than schizophrenia Pregnancy Patients with chronic metabolic diseases such as diabetes, heart problems and cancer'}, 'identificationModule': {'nctId': 'NCT06572657', 'briefTitle': 'Comparison of the Effects of Aerobic Exercise and Computerized Cognitive Stimulation in Patients With Schizophrenia - A Randomized Controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'Comparison of the Effects of Aerobic Exercise and Computerized Cognitive Stimulation in Patients With Schizophrenia - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'İsmailK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cognitive stimulation group', 'description': 'cognitive stimulation', 'interventionNames': ['Other: cognitive stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'physical exercise group', 'description': 'physical exercise', 'interventionNames': ['Other: physical exercise']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'no intervention'}], 'interventions': [{'name': 'cognitive stimulation', 'type': 'OTHER', 'description': 'cognitive stimulation', 'armGroupLabels': ['cognitive stimulation group']}, {'name': 'physical exercise', 'type': 'OTHER', 'description': 'physical exercise', 'armGroupLabels': ['physical exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kartal Dr Lütfi Kırdar Şehir Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'İsmail Koç', 'investigatorAffiliation': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}}}}