Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-01 @ 2:37 PM
Study NCT ID:
NCT05078203
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Cognition and Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '18 adults with healthy weight (BMI 18.5-25.0kg/m2) and 18 adults with obesity (BMI 30.0kg/m2) will be asked to complete a counter-balanced crossover trial. After initial baseline testing, participants will be asked to complete either an acute exercise bout or sedentary control session in a counter-balanced order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating Cathepsin B (CTSB) Myokine', 'timeFrame': '3 hours', 'description': 'Changes in peripheral myokine concentration'}, {'measure': 'Attentional Inhibition Accuracy', 'timeFrame': '3 hours', 'description': 'Behavioral performance measured as accuracy (%) during Flanker task'}, {'measure': 'Attentional Inhibition Reaction Time', 'timeFrame': '3 hours', 'description': 'Behavioral performance measured as response time (ms) during Flanker task'}, {'measure': 'Attentional Resource Allocation', 'timeFrame': '3 hours', 'description': 'Changes in P3 event related potential amplitude (microvolts) using a computerized flanker task'}, {'measure': 'Attentional Processing Speed', 'timeFrame': '3 hours', 'description': 'Changes in P3 event related potential latency (ms) using a computerized flanker task'}, {'measure': 'Relational Memory', 'timeFrame': '3 hours', 'description': 'Accuracy during a spatial reconstruction task'}], 'secondaryOutcomes': [{'measure': 'Brain derived neurotrophic factor (BDNF)', 'timeFrame': '3 hours', 'description': 'Changes in peripheral BDNF concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myokine', 'Cognition', 'CTSB', 'BDNF', 'Exercise'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The central hypothesis is that, while both groups will benefit from the exercise session, participants with obesity will exhibit greater gains in cognitive control, relative to healthy weight adults. Additionally, it is anticipated that the benefits of a single bout of exercise for cognitive control will be mediated by changes in exercise-induced myokines. These hypotheses will be tested by accomplishing three aims:\n\nAim 1: Elucidate the changes in cognitive control following an acute bout of exercise, relative to a sedentary condition, in persons with and without obesity.\n\nAim 2: To examine the effect of a single bout of exercise, relative to a sedentary condition, on myokines known to have neuroprotective effects i.e., BDNF and CTSB in both healthy weight and individuals with obesity.\n\nAim 3: To link changes in exercise-induced myokines (i.e., BDNF and CTSB) to changes in cognitive function, following a single bout of exercise.', 'detailedDescription': '18 adults with healthy weight (BMI 18.5-25.0kg/m2) and 18 adults with obesity (BMI 30.0kg/m2) will be asked to complete a counter-balanced crossover trial. After initial baseline testing, participants will be asked to complete either an acute exercise bout or sedentary control session in a counter-balanced order. A cognitive testing battery accompanied by an electroencephalogram (EEG) will be administered following each session. Blood samples will be collected prior to, during, and following each throughout each testing condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between ages 18 and 35\n* No prior diagnosis of neurological disorders (e.g., autism spectrum disorder)\n* No prior diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)\n* No physical disability that would preclude the participant from completing a VO2max test\n* Corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)\n* Not pregnant\n* BMI between 18.5 and 25.0 kg/m2, or BMI greater than 30.0 kg/m2\n* Readiness for exercise (determined through PAR-Q)\n\nExclusion Criteria:\n\n* \\<18 years and \\>35 years\n* Diagnosis of neurological disorders (e.g., autism spectrum disorder)\n* Diagnosis of metabolic disease (e.g., diabetes, cardiovascular disease)\n* Physical disability that would preclude the participant from completing a VO2max test\n* Lack of corrected vision (based on the minimal 20/20 standard needed to complete cognitive tasks)\n* Pregnancy\n* BMI less than 18.5 kg/m2 or BMI greater than 25.0 but less than 30.0 kg/m2'}, 'identificationModule': {'nctId': 'NCT05078203', 'acronym': 'ACE', 'briefTitle': 'Acute Cognition and Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Acute Exercise and Cognitive Function: Examining the Role of Weight Status and Exercise-Induced Myokines', 'orgStudyIdInfo': {'id': 'ACE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': '36 minutes of exercise', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Rest', 'description': '36 minutes of rest', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': '36 minutes of Exercise', 'armGroupLabels': ['Exercise', 'Rest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Urbana-Champaign', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}