Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-07 @ 1:40 PM
Study NCT ID:
NCT03800368
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2019-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Overnight Motor Sequence Task
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-08', 'studyFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2019-01-08', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The sleep-dependent procedural memory consolidation after 12 weeks of intervention', 'timeFrame': '12-week Follow-up', 'description': 'Tested by comparing the finger-tapping motor sequence task performance between the three groups during the 12-week follow-up assessment.'}], 'secondaryOutcomes': [{'measure': 'The verbal memory consolidation after 12 weeks of intervention', 'timeFrame': '12-week Follow-up', 'description': 'Tested by comparing the logical memory task performance between the three groups during the 12-week follow-up assessment'}, {'measure': 'The attention performance after 12 weeks of intervention', 'timeFrame': '12-week Follow-up', 'description': 'Measured by using the cancellation task performance and compare between the three groups during the 12-week follow-up assessment'}, {'measure': 'The sleep quality after 12 weeks of intervention', 'timeFrame': '12-week Follow-up', 'description': 'Measured by using the Pittsburgh Sleep Quality Index (PSQI) and compare the differences between the three groups during the 12-week follow-up assessment'}, {'measure': 'The insomnia severity after 12 weeks of intervention', 'timeFrame': '12-week Follow-up', 'description': 'Measured by using the Insomnia Severity Index (ISI) and compare the differences between the three groups during the 12-week follow-up assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Sleep-dependent memory consolidation', 'Aerobic', 'Anaerobic'], 'conditions': ['Schizophrenia and Related Disorders', 'Psychotic Disorders']}, 'referencesModule': {'references': [{'pmid': '34615565', 'type': 'DERIVED', 'citation': 'Lo LLH, Lee EHM, Hui CLM, Chong CSY, Chang WC, Chan SKW, Lin JJ, Lo WTL, Chen EYH. Effect of high-endurance exercise intervention on sleep-dependent procedural memory consolidation in individuals with schizophrenia: a randomized controlled trial. Psychol Med. 2023 Apr;53(5):1708-1720. doi: 10.1017/S0033291721003196. Epub 2021 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this randomized controlled trial (RCT) is to compare the changes of the sleep-related memory functions in patients with psychosis after they have completed the 12-week high-intensity exercise intervention, the 12-week low-intensity exercise intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one patients with psychosis, patients who received either the high-intensity exercise or low-intensity exercise as intervention shown a significant improvement to their impaired sleep-related memory function, while those who received non-exercise intervention has no such improvement. Moreover, high-intensity exercise may have a more prominent effect compare to low-intensity exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged from 18 to 55\n* Based on the SCID diagnosed to have schizophrenia and related psychotic disorders\n* Ability to understand the nature of the study and to give written informed consent\n\nExclusion Criteria:\n\n* Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders\n* Comorbid substance dependence\n* Unstable psychotic symptoms\n* A history of brain trauma or organic brain disease\n* Known history of intellectual disability or special school attendance\n* Answered one or more "yes" in the PAR-Q and without doctors approval for exercise'}, 'identificationModule': {'nctId': 'NCT03800368', 'acronym': 'EOMST', 'briefTitle': 'Exercise and Overnight Motor Sequence Task', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': '12-week Aerobic-Anaerobic Transition Exercise Intervention and Overnight Sleep-dependent Procedural Memory Consolidation in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'HKU_Psych'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-endurance group', 'description': 'This group of subjects will receive 2-3 sessions of high-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will interchange between the aerobic and anaerobic state.', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Low-endurance group', 'description': 'This group of subjects will receive 2-3 sessions of low-intensity cycling exercise training per week, for a total of 12 weeks. The exercise the subjects received will maintain at an aerobic level.', 'interventionNames': ['Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psycho-education', 'description': 'This group of subjects will receive 2-3 sessions of psycho-education class per week, for a total of 12 weeks. The content of the class includes non-exercise related psycho-education content to participants (e.g., food hygiene, psychological well being, food nutrition, etc).', 'interventionNames': ['Other: Non-exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Indoor cycling exercise intervention', 'armGroupLabels': ['High-endurance group', 'Low-endurance group']}, {'name': 'Non-exercise', 'type': 'OTHER', 'description': 'Psycho-education', 'armGroupLabels': ['Psycho-education']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lik Hang Lincoln Lo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Fellow', 'investigatorFullName': 'Dr. Lincoln Lik-Hang Lo', 'investigatorAffiliation': 'The University of Hong Kong'}}}}