Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-21 @ 1:34 AM
Study NCT ID:
NCT03313895
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2017-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Combined Aerobic Exercise and Cognitive Training (ACT) Trial: The ACT Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Executive function', 'timeFrame': 'Change from baseline to 3, 6, 12, and 18 months', 'description': 'EXAMINER'}, {'measure': 'Episodic memory', 'timeFrame': 'Change from baseline to 3, 6, 12, and 18 months', 'description': 'RAVLT and BVMTR'}, {'measure': 'AD-signature cortical thickness', 'timeFrame': 'Change from baseline to 6, 12, and 18 months', 'description': 'Magnetic Resonance Imaging (MRI)'}, {'measure': 'Functional connectivity in DMN', 'timeFrame': 'Change from baseline to 6, 12, and 18 months', 'description': 'Functional MRI for Default Mode Network'}, {'measure': 'Aerobic fitness', 'timeFrame': 'Change from baseline to 3, 6, 12, and 18 months', 'description': 'VO2peak from symptom-limited peak cycle-ergometer test, and 10-m Incremental Shuttle Walk Test'}, {'measure': "Conversion to Alzheimer's disease", 'timeFrame': 'Change from baseline to 6, 12, and 18 months', 'description': "Clinical adjudication of Alzheimer's disease dementia"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'exercise', 'cognitive training', 'imaging'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '40262108', 'type': 'DERIVED', 'citation': 'Derboghossian G, Pituch K, Anthony M, Salisbury D, Lin FV, Yu F. Relationships among cardiorespiratory fitness, brain age, and neurodegeneration in older adults with amnestic mild cognitive impairment. J Alzheimers Dis. 2025 Jun;105(3):945-954. doi: 10.1177/13872877251333613. Epub 2025 Apr 22.'}, {'pmid': '39948366', 'type': 'DERIVED', 'citation': "Salisbury DL, Lin FV, Yu F. Testing the iMplementation Framework fOr behavioral and LIfestyLe interventions in AlZheimer's DiseasE (MOBILIZE) via the ACT randomized controlled trial. Sci Rep. 2025 Feb 13;15(1):5341. doi: 10.1038/s41598-025-88890-9."}, {'pmid': '31907024', 'type': 'DERIVED', 'citation': 'Li D, Mielke MM, Bell WR, Reilly C, Zhang L, Lin FV, Yu F. Blood biomarkers as surrogate endpoints of treatment responses to aerobic exercise and cognitive training (ACT) in amnestic mild cognitive impairment: the blood biomarkers study protocol of a randomized controlled trial (the ACT Trial). Trials. 2020 Jan 6;21(1):19. doi: 10.1186/s13063-019-3798-1.'}, {'pmid': '30577848', 'type': 'DERIVED', 'citation': 'Yu F, Lin FV, Salisbury DL, Shah KN, Chow L, Vock D, Nelson NW, Porsteinsson AP, Jack C Jr. Efficacy and mechanisms of combined aerobic exercise and cognitive training in mild cognitive impairment: study protocol of the ACT trial. Trials. 2018 Dec 22;19(1):700. doi: 10.1186/s13063-018-3054-0.'}]}, 'descriptionModule': {'briefSummary': "This multi-site clinical trial occurs at the University of Minnesota and University of Rochester. It tests the efficacy and additive/synergistic effects of an ACT intervention on cognition and relevant mechanisms (aerobic fitness, Alzheimer's disease \\[AD\\] signature cortical thickness, and default mode network \\[DMN\\]) in older adults with amnestic MCI (aMCI).", 'detailedDescription': "Because almost all drug trials for Alzheimer's disease (AD) have failed, developing non-pharmacological interventions with strong potential to prevent or delay the onset of AD in high-risk populations (e.g., those with mild cognitive impairment \\[MCI\\]) is critically important. Aerobic exercise and cognitive training are 2 promising interventions for preventing AD. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective neural function intensively. Hence, combined Aerobic exercise and Cognitive Training (ACT) may very well have an additive or synergistic effect on cognition by complementary strengthening of different neural functions. Few studies have tested ACT's effects, and those studies have reported discrepant findings, largely due to varying ACT programs. The purpose of this single-blinded, 2×2 factorial Phase II randomized controlled trial (RCT) is to test the efficacy and additive/synergistic effects of a 6-month combined cycling and speed of processing (SOP) training intervention on cognition and relevant mechanisms (aerobic fitness, AD signature cortical thickness, and functional connectivity in the default mode network \\[DMN\\]) in older adults with amnestic MCI (aMCI)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A clinical diagnosis of MCI\n* Community-dwelling\n* Age 65 years and older\n* English-speaking\n* Adequate visual acuity\n* Verified exercise safety by medical provider\n* Stable on drugs affecting cognitive and psychological status\n* Verified MRI safety\n* Capacity to consent\n\nExclusion Criteria:\n\n* Geriatric Depression Scale \\< 5\n* Resting heart rate (HR) ≤50 due to arrhythmia or ≥100 beats/min\n* Neurological (e.g., dementia, head trauma), psychiatric (e.g., bipolar, schizophrenia, or depression), or substance dependency (alcohol or chemical dependency) in the past 5 years that are the main contributor to MCI\n* Contraindications to exercise, e.g. unstable angina, recent surgery\n* New symptoms or diseases that have not been evaluated by a health care provider\n* Current enrollment in another intervention study related to cognitive improvement (reduce confounding effects on outcomes)\n* Abnormal MRI findings'}, 'identificationModule': {'nctId': 'NCT03313895', 'briefTitle': 'The Combined Aerobic Exercise and Cognitive Training (ACT) Trial: The ACT Trial', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training (ACT) in MCI', 'orgStudyIdInfo': {'id': 'STUDY00001135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cycling Only', 'description': 'Moderate-intensity cycling, 3 times a week for 6 months, supervised by an exercise specialist', 'interventionNames': ['Behavioral: Cycling Only']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Training Only', 'description': 'Computerized cognitive training, 3 times a week for 6 months, supervised by a specialist', 'interventionNames': ['Behavioral: Cognitive Training Only']}, {'type': 'EXPERIMENTAL', 'label': 'ACT', 'description': 'Moderate-intensity cycling followed by computerized cognitive training, 3 times a week for 6 months, supervised by a specialist', 'interventionNames': ['Behavioral: Aerobic & Cognitive Training (ACT)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Stretching and Mental Stimulation Activities', 'description': 'Stretching and mental stimulation activities, 3 times a week for 6 months, supervised by a specialist', 'interventionNames': ['Behavioral: Stretching and Mental Stimulating Activities']}], 'interventions': [{'name': 'Aerobic & Cognitive Training (ACT)', 'type': 'BEHAVIORAL', 'description': 'ACT stands for combined aerobic exercise and cognitive training.', 'armGroupLabels': ['ACT']}, {'name': 'Cycling Only', 'type': 'BEHAVIORAL', 'description': 'Cycling on a recumbent stationary cycle', 'armGroupLabels': ['Cycling Only']}, {'name': 'Cognitive Training Only', 'type': 'BEHAVIORAL', 'description': 'Engage in cognitive training on a computer', 'armGroupLabels': ['Cognitive Training Only']}, {'name': 'Stretching and Mental Stimulating Activities', 'type': 'BEHAVIORAL', 'description': 'Stretching exercises and mental stimulating activities on a computer', 'armGroupLabels': ['Stretching and Mental Stimulation Activities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Fang Yu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Rochester', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'University of St Thomas', 'class': 'UNKNOWN'}, {'name': 'University of Minnesota', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}