Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT04987151
Status:
UNKNOWN
Last Update Posted:
2021-08-03
First Post:
2021-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Different Modalities of Exercise in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-23', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-23', 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': '16 weeks', 'description': 'Symptoms of schizophrenia are measured according to the subscale scores and total score on the PANSS which consists of 30 items scored from 1 (Absent) to 7 (Extreme). Scores range from 30 to 210, with higher scores indicating more symptoms'}], 'secondaryOutcomes': [{'measure': 'World Health Organization Quality of Life-Short version (WHOQOL-BREF)', 'timeFrame': '16 weeks', 'description': 'The WHOQOL-BREF contains 24 questions covering 4 domains plus two questions related to overall quality of life and satisfaction with health. Highes scores represent higher quality of life.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': '16 weeks', 'description': 'The BMI is defined as the body mass divided by the square of the body height.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '34535474', 'type': 'DERIVED', 'citation': 'Garcia-Garces L, Lacamara Cano S, Cebolla Melia Y, Sanchez-Lopez MI, Marques Azcona D, Lison JF, Peyro-Gregori L. Comparison of three different exercise training modalities (aerobic, strength and mixed) in patients with schizophrenia: study protocol for a multicentre randomised wait-list controlled trial. BMJ Open. 2021 Sep 17;11(9):e046216. doi: 10.1136/bmjopen-2020-046216.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Numerous studies support the practice of different physical exercise modalities as an effective treatment to address the different problems associated with schizophrenia, reporting that they result in significant improvements in patient symptoms and quality of life. Given the lack of studies comparing different types of training in controlled environments, the aim of this proposed study will be to compare the effects of three physical exercise programs (strength, aerobic, and mixed) on the symptoms, body composition, level of physical activity, and health-related quality of life of patients with schizophrenia.\n\nEthics and dissemination: This study was approved by the ethics committees for Biomedical Research at the CEU Cardenal Herrera University of Valencia in Spain (reference number: CEI18/215). Participants will be fully informed of the purpose and procedures of the study, and written informed consent will be obtained from every participant. The results from this study will be published in peer-reviewed journals and presented in scientific conferences.', 'detailedDescription': 'The aim of this proposed study will be to compare the effects of three physical exercise programs (strength, aerobic, and mixed) on the symptoms, body composition, level of physical activity, and health-related quality of life of patients with schizophrenia.\n\nA multicentre, single-blinded (evaluator), randomised, wait-list controlled (ratio 2:2:2:1) trial will be conducted with 105 patients recruited from different psychosocial care centres. The participants will be randomised into three 16-week training groups comprising 48 sessions lasting one hour each, or to the wait-list control group. The training groups will complete aerobic, strength, or mixed (aerobic + strength) training. The participants will be assessed before, immediately after, and 6 months after the end of the intervention. All the patients in the wait-list control group (n = 15) will receive one of the three trainings immediately after the intervention. The study variables will include positive symptomatology, negative symptomatology, and general symptomology (using the Positive and Negative Syndrome Scale) as the primary outcome; as secondary outcome: body composition (by assessing body mass index, body fat mass and waist circumference), physical activity levels (International Physical Activity Questionnaire-Short Form), and quality of life (abbreviated World Health Organization Quality of Life questionnaire).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Schizophrenia\n* Age between 18-65 years\n\nExclusion Criteria:\n\n* Patients with other mental diseases\n* Patients with mental disabilities\n* Patients who present motor or behavioral pathologies that prevent the realization of the exercise training.'}, 'identificationModule': {'nctId': 'NCT04987151', 'briefTitle': 'The Effects of Different Modalities of Exercise in Patients With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'Comparison of Three Different Exercise Training Modalities (Aerobic, Strength, and Mixed) in Patients With Schizophrenia: Study Protocol for a Multi-centre Randomised Wait-list Controlled Trial', 'orgStudyIdInfo': {'id': 'UNIVERSITY UCH-CEU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strength training', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups.', 'interventionNames': ['Other: Experimental-Strength training']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic training', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking,', 'interventionNames': ['Other: Experimental-Aerobic training']}, {'type': 'EXPERIMENTAL', 'label': 'Strength/Aerobic training', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups', 'interventionNames': ['Other: Experimental-Strength/Aerobic training']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'All the patients in the wait-list control group will receive one of the three trainings immediately after the intervention.'}], 'interventions': [{'name': 'Experimental-Strength training', 'type': 'OTHER', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups', 'armGroupLabels': ['Strength training']}, {'name': 'Experimental-Aerobic training', 'type': 'OTHER', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking.', 'armGroupLabels': ['Aerobic training']}, {'name': 'Experimental-Strength/Aerobic training', 'type': 'OTHER', 'description': 'Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups.', 'armGroupLabels': ['Strength/Aerobic training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46115', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Universidad CEU-Cardenal Herrera', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Laura García Garcés, Dr.', 'role': 'CONTACT', 'email': 'lauragarciagarcesphd@gmail.com', 'phone': '96 136 90 00', 'phoneExt': '64352'}, {'name': 'María Inmaculada Sánchez López, Dr', 'role': 'CONTACT', 'email': 'maria.sanchez6@uchceu.es', 'phone': '96 136 90 00', 'phoneExt': '64535'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Inmediately following publication.', 'ipdSharing': 'YES', 'description': 'Individual deidentified participant data will be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Nursing and Physiotherapy', 'investigatorFullName': 'Laura García Garcés', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}