Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-30 @ 6:48 AM
Study NCT ID:
NCT01179958
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2010-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Benefits of Aerobic Exercise Across the Age Span
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2010-08-10', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in measures of executive control function and episodic memory at 6 months', 'timeFrame': '24 weeks', 'description': 'tests of global intelligence, executive function, working memory and processing speed'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in brain structure, resting cerebral blood flow and network efficiency at 6 months', 'timeFrame': '24 weeks', 'description': 'structural MRI (for gray matter density), resting CBF (cerebral blood flow, measured by arterial spin labeling) and cognitive activation fMRI studies'}, {'measure': 'Change from baseline in measures of interleukin-6, tumor necrosis factor alpha, C-reactive protein at 6 months', 'timeFrame': 'Baseline and 24 weeks'}, {'measure': 'Change from baseline in aerobic capacity at 6 months', 'timeFrame': '24 weeks', 'description': 'aerobic capacity as measured by VO2 max'}, {'measure': 'Change from baseline in measures of executive control function and episodic memory at 1 year', 'timeFrame': '48 weeks', 'description': 'tests of global intelligence, executive function, working memory and processing speed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cognitive function', 'fMRI', 'apoE', 'inflammatory markers', 'exercise'], 'conditions': ['Cognitive Function']}, 'referencesModule': {'references': [{'pmid': '34276329', 'type': 'DERIVED', 'citation': 'Predovan D, Gazes Y, Lee S, Li P, Sloan RP, Stern Y. Effect of Aerobic Exercise on White Matter Tract Microstructure in Young and Middle-Aged Healthy Adults. Front Hum Neurosci. 2021 Jul 2;15:681634. doi: 10.3389/fnhum.2021.681634. eCollection 2021.'}, {'pmid': '30700591', 'type': 'DERIVED', 'citation': 'Stern Y, MacKay-Brandt A, Lee S, McKinley P, McIntyre K, Razlighi Q, Agarunov E, Bartels M, Sloan RP. Effect of aerobic exercise on cognition in younger adults: A randomized clinical trial. Neurology. 2019 Feb 26;92(9):e905-e916. doi: 10.1212/WNL.0000000000007003. Epub 2019 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that aerobic exercise leads improved cognitive function accompanied by increases in gray matter density and changes in functional magnetic resonance imaging (fMRI) patterns of task-related activation.', 'detailedDescription': 'While animal and human studies indicate cognitive benefits from aerobic exercise across the lifespan, the great majority of controlled exercise studies in humans have been restricted to elderly individuals. Those studies have indicated that enhancing aerobic capacity has a beneficial effect on cognition. One study suggests that this benefit is seen particularly for executive control processes, precisely the processes affected by aging. These improvements have been accompanied by increases in gray matter density and changes in functional magnetic resonance imaging (fMRI) patterns of task-related activation. The goal of the proposed study is to extend the investigation of the beneficial effects of aerobic exercise to younger individuals, and to compare these effects in young and old.\n\nIn this application the study team propose to conduct a study in which 270 sedentary but otherwise healthy and cognitively intact individuals in the 20-68 year age range are randomized to two training conditions, aerobic exercise and stretching/toning, to be completed at YMCAs and YMHAs in New York City. Participants will be assessed for aerobic capacity, cognitive task performance, and by structural MRI, resting cerebral blood flow scans (arterial spin labeling) and cognitive activation fMRI studies at study entry and after 6 months of training.\n\nThe study also proposes two complementary approaches to investigating the neural correlates of the beneficial effects of aerobic exercise on cognition: 1) imaging -- a combination of structural, metabolic, and cognitive activation fMRI studies to evaluate the neural substrates of the effect of aerobic exercise on cognition will be used. 2) important correlates -- the effects of apolipoprotein E (APOE) genotype, inflammatory markers and cognitive reserve on the cognitive effects of aerobic exercise will be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 20-68\n2. English-speaking\n3. strongly right-handed\n4. BMI \\< 35\n5. Pre-menopausal (women only): no oral contraceptive use Post-menopausal: no estrogen replacement therapy\n6. sedentary: VO2 max \\< 41 and 31.6 ml/kg/min for men age 20-40 and 50-68 and \\< 35.2 and 26.6 ml/kg/min for women age 20-40 and 50-68 respectively\n7. participants over age 60 must have ECG within past 3 months\n\nExclusion Criteria:\n\n1. MRI contraindications (e.g., metallic implants, pacemaker, weight \\> 350 lbs, waist \\> 55")\n2. Hearing impaired/hearing aids, unable to read newspaper at arm\'s length with corrective lenses\n3. Objective cognitive impairment\n4. Ischemic changes, abnormal blood pressure responses, or any significant ectopy during aerobic capacity testing\n5. Cardiovascular disease\n6. Uncontrolled high blood pressure (systolic blood pressure ≥ 140 mmHg; or diastolic blood pressure ≥ 90 mmHg on two measures)\n7. Current or recent (evidence of disease x 5 years) non-skin neoplastic disease or melanoma\n8. Active hepatic disease (not a history of hepatitis) or primary renal disease requiring dialysis, primary untreated endocrine diseases, e.g., Cushing\'s disease or primary hypothalamic failure or insulin dependent diabetes (Type I or II).\n9. HIV infection\n10. Pregnant or lactating (participation allowed 3 months after ceasing lactation\n11. Medications that target CNS (central nervous system, e.g., neuroleptics, anticonvulsants, antidepressants, benzodiazepines) within the last month\n12. Women: any selective estrogen receptor modulator or aromatase inhibitor Men: androgen ablation/deprivation hormonal therapies\n13. Any history of psychosis or electroconvulsive therapy\n14. Psychotic disorder (lifetime)\n15. Current or recent (within past 12 months) alcohol or substance abuse or dependence. Recent use (past month) of recreational drugs.\n16. Brain disorder such as stroke, tumor, infection, epilepsy, multiple sclerosis, degenerative diseases, head injury, mental retardation\n17. Imaged cortical stroke or large subcortical lacunae or infarct or space-occupying lesion (≥ 2 cubic cm). Other findings, e.g., periventricular caps or small white matter hyperintensities, do not result in exclusion\n18. Diagnosed learning disability, dyslexia\n19. Current or recent (Past 5 years) Major Depressive Disorder, Bipolar Disorder, or Anxiety Disorder\n20. Dementia Rating Scale \\< 135'}, 'identificationModule': {'nctId': 'NCT01179958', 'briefTitle': 'Cognitive Benefits of Aerobic Exercise Across the Age Span', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Cognitive Benefits of Aerobic Exercise Across the Age Span', 'orgStudyIdInfo': {'id': '#6211/7140R'}, 'secondaryIdInfos': [{'id': 'AG030092', 'type': 'OTHER', 'domain': 'CU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aerobic training', 'description': '24 weeks of aerobic training, 4 times/week', 'interventionNames': ['Behavioral: aerobic training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'stretching/toning', 'description': 'stretching/toning condition, 24 weeks to parallel the active intervention group', 'interventionNames': ['Behavioral: stretching/toning']}], 'interventions': [{'name': 'aerobic training', 'type': 'BEHAVIORAL', 'otherNames': ['Training, aerobic'], 'description': '24 weeks of aerobic training, 4X/week', 'armGroupLabels': ['aerobic training']}, {'name': 'stretching/toning', 'type': 'BEHAVIORAL', 'otherNames': ['Exercises, stretches and toning'], 'description': 'stretches and toning exercises designed to promote flexibility and improved core strength', 'armGroupLabels': ['stretching/toning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10013', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Richard Sloan', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Richard P Sloan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Yaakov Stern, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Chief', 'investigatorFullName': 'Richard Sloan', 'investigatorAffiliation': 'New York State Psychiatric Institute'}}}}