Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-04-11 @ 6:51 PM
Study NCT ID:
NCT04830059
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Joint Effect of Air Pollution and Exercise on Cognitive Function
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and investigators are blinded, and part of the outcome assessors are blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double blind randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-06', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of cognitive function', 'timeFrame': 'Before and after acute exercise (about 30 minutes).', 'description': 'Cognitive function measured by computer-based tasks including executive function'}, {'measure': 'Change of biomarkers', 'timeFrame': 'Before and after acute exercise (about 30 minutes).', 'description': 'The cognitive-related biomarkers including brain derived neurotrophic factor'}, {'measure': 'Change of oxyhemoglobin', 'timeFrame': 'Before and after acute exercise (about 30 minutes).', 'description': 'Mearsurement of oxyhemoglobin using fNIRS'}, {'measure': 'Change of transcriptions', 'timeFrame': 'Before and after acute exercise (about 30 minutes).', 'description': 'The molecular response of exercise and environment through the measurement of peripheral blood'}, {'measure': 'Change of metabonomics', 'timeFrame': 'Before and after acute exercise (about 30 minutes).', 'description': 'The molecular response of exercise and environment through the measurement of peripheral blood'}, {'measure': 'Change of cerebral blood flow', 'timeFrame': 'Before and after acute exercise (about 30 minutes).', 'description': 'The blood flow of middle cerebral artery measured by ultrasonic doppler'}], 'secondaryOutcomes': [{'measure': 'Change of cognitive function', 'timeFrame': 'Three months (from baseline to the third month)', 'description': 'Cognitive function measured by computer-based tasks including executive function'}, {'measure': 'Change of aerobic capacity', 'timeFrame': 'Three months (from baseline to the third month)', 'description': 'The aerobic capacity measured by the gas metabolism analyzer'}, {'measure': 'Change of cerebral blood flow', 'timeFrame': 'Three months (from baseline to the third month)', 'description': 'The blood flow of middle cerebral artery measured by ultrasonic doppler'}, {'measure': 'Change of biomarkers', 'timeFrame': 'Three months (from baseline to the third month)', 'description': 'The cognitive-related biomarkers including brain derived neurotrophic factor'}, {'measure': 'Change of oxyhemoglobin', 'timeFrame': 'Three months (from baseline to the third month)', 'description': 'Mearsurement of oxyhemoglobin using functional near infrared spectroscopy'}, {'measure': 'Change of metabonomics', 'timeFrame': 'Three months (from baseline to the third month)', 'description': 'The molecular response of exercise through the measurement of peripheral blood'}, {'measure': 'Change of transcriptions', 'timeFrame': 'Three months (from baseline to the third month)', 'description': 'The molecular response of exercise through the measurement of peripheral blood'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise', 'Air Pollution', 'Cognition', 'Health Promotion']}, 'referencesModule': {'references': [{'pmid': '37217511', 'type': 'DERIVED', 'citation': 'Liu J, Min L, Liu R, Zhang X, Wu M, Di Q, Ma X. The effect of exercise on cerebral blood flow and executive function among young adults: a double-blinded randomized controlled trial. Sci Rep. 2023 May 22;13(1):8269. doi: 10.1038/s41598-023-33063-9.'}, {'pmid': '36590621', 'type': 'DERIVED', 'citation': 'Liu J, Zhang Y, Li X, Wang D, Shi B, You Y, Min L, Luo B, Li Y, Di Q, Ma X. Exercise improves mental health status of young adults via attenuating inflammation factors but modalities matter. Front Psychiatry. 2022 Dec 14;13:1067890. doi: 10.3389/fpsyt.2022.1067890. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'A double-blind randomized controlled trial design is used in this study. A mixed design of 2 (pollution reduction group vs. no pollution reduction group) × 3 (high intensity intermittent exercise \\[HIIT\\], moderate intensity of aerobic exercise \\[MICT\\] and control group \\[CONT\\]) is used. 93 subjects recruited by advertising will be randomly divided into 6 groups: high intensity exercise group (pollution reduction vs no pollution reduction), moderate intensity aerobic exercise group (pollution reduction vs no pollution reduction) and Stretching group (Control) (pollution reduction vs no pollution reduction).', 'detailedDescription': 'Environmental intervention program In the pollution reduction groups, the air purification system is used 2 hours before the subjects entered the room to minimize the indoor PM2.5 and PM10.\n\nExercise intervention program including HIIT, MICT and Stretching (Control) group :\n\nThe VO2max of all subjects are measured one week before the experiment. HIIT program: 20 minutes exercise of HIIT (1min of 100% VO2max and 1min of 50% VO2max alternately) and 10 minutes of warm-up and relaxation.\n\nMICT program: 20 minutes exercise of 70-75% VO2max and 10 minutes of warm-up and relaxation.\n\nStretching control group: 30 minutes of stretching, posture adjustment and rehabilitation courses taught by professional therapists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No regular exercise in the past six months;\n* Healthy people without history of disease;\n* Aged between 20 and 30 years old.\n\nExclusion Criteria:\n\n* Professional athletes;\n* Regular exercise in the past six months;\n* People who are injured or have a history of disease in the past six months;\n* People who have a history of taking medicine in the past six months.'}, 'identificationModule': {'nctId': 'NCT04830059', 'briefTitle': 'The Joint Effect of Air Pollution and Exercise on Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'Tsinghua University'}, 'officialTitle': 'The Joint Effect of Air Pollution and Exercise on Cognitive Function', 'orgStudyIdInfo': {'id': 'THU2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High intensity intermittent training', 'description': 'HIIT exercise program: 20 minutes HIIT exercise (1min 100% VO2max and 1min 50% VO2max alternately), and warm-up and relaxation before and after exercise for 10 minutes.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'HIIT with pollution reduction', 'description': 'HIIT program: 20 minutes HIIT exercise (1min 100% VO2max and 1min 50% VO2max alternately), and warm-up and relaxation before and after exercise for 10 minutes; Environmental pollution intervention program: air purification system is used order to reduce the PM2.5 and PM10.', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Air purification']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate intensity continuous training', 'description': 'MICT program: 20 minutes of 70-75% VO2max exercise and 10 minutes of warm-up and relaxation before and after exercise.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'MICT with pollution reduction', 'description': 'MICT program: 20 minutes of 70-75% VO2max exercise and 10 minutes of warm-up and relaxation before and after exercise; Environmental pollution intervention program: air purification system is used order to reduce the PM2.5 and PM10.', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Air purification']}, {'type': 'EXPERIMENTAL', 'label': 'Stretch control group', 'description': 'Stretching control group: 30 minutes stretching, posture adjustment and rehabilitation courses is taught by professional therapist.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Control with pollution reduction', 'description': 'Stretching control group: 30 minutes stretching, posture adjustment and rehabilitation courses is taught by professional therapist.\n\nEnvironmental pollution intervention program: air purification system is used order to reduce the PM2.5 and PM10.', 'interventionNames': ['Behavioral: Exercise', 'Behavioral: Air purification']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'Two types of exercise intervention and control group', 'armGroupLabels': ['Control with pollution reduction', 'HIIT with pollution reduction', 'High intensity intermittent training', 'MICT with pollution reduction', 'Moderate intensity continuous training', 'Stretch control group']}, {'name': 'Air purification', 'type': 'BEHAVIORAL', 'description': 'Air purification in order to reduce the PM2.5 and PM10', 'armGroupLabels': ['Control with pollution reduction', 'HIIT with pollution reduction', 'MICT with pollution reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100084', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Tsinghua University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Qian Di, Sc.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wanke School of public health, Tsinghua University'}, {'name': 'Xindong Ma, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of physical education, Tsinghua University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tsinghua University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research staff', 'investigatorFullName': 'Jianxiu Liu', 'investigatorAffiliation': 'Tsinghua University'}}}}