Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-01-02 @ 7:25 AM
Study NCT ID:
NCT06574893
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Exercise on Simple Inflammatory Markers, Systemic Immune Inflammation Index, and Systemic Immune Response Index
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': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sociodemographic characteristics.', 'timeFrame': '12 weeks', 'description': 'It will be asked to fill out a structured questionnaire covering their sociodemographic characteristics.'}, {'measure': 'simple inflammatory markers', 'timeFrame': '12 weeks', 'description': 'Index Calculation Based on Complete Blood Count'}], 'secondaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale', 'timeFrame': '12 weeks', 'description': 'Positive and Negative Syndrome Scale will be used for detecting positive and negative syndromes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Physical Exercise']}, 'descriptionModule': {'briefSummary': 'Mental health is defined as a state of well-being in which a person can realize their talents, cope with the normal stresses of life, and support society by working efficiently and productively. In other words, mental health is a dynamic internal balance that enables individuals to use their diversity of skills in harmony with the universal values of society.', 'detailedDescription': 'The aim of this study was to investigate the effect of physical exercise on simple inflammation markers, systemic immune inflammation index and systemic inflammation response index in patients with schizophrenia. No other study examining the effect of exercise on these parameters was found in the literature. Therefore, considering the importance of our study, our findings may contribute to the literature and improvement for mental health systems, especially for people with psychotic disorders such as schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals diagnosed with schizophrenia by a physician according to DSM-V criteria\n* Individuals with schizophrenia who are 18 -55 years\n\nExclusion Criteria:\n\n* Those who do not 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': 'NCT06574893', 'briefTitle': 'Physical Exercise on Simple Inflammatory Markers, Systemic Immune Inflammation Index, and Systemic Immune Response Index', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Lutfi Kirdar Kartal Training and Research Hospital'}, 'officialTitle': 'The Effects of Physical Exercise on Simple Inflammatory Markers, Systemic Immune Inflammation Index, and Systemic Immune Response Index in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'Keah_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'physical exercise group', 'description': 'physical exercise', 'interventionNames': ['Other: physical exercise']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'no intervention'}], 'interventions': [{'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'}}}}