Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-30 @ 7:24 AM
Study NCT ID:
NCT06114550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Training on Growth Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-04-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rata of perceived exertion', 'timeFrame': '"0 minutes" "60 minutes" "90 minutes"', 'description': "The rating of perceive exertion (RPE) questionnaire scale was applied to assess participants' subjective fatigue feeling throughout the training period."}, {'measure': 'Blood lactate', 'timeFrame': '"0 minutes" "60 minutes" "90 minutes"', 'description': 'serum blood lactate'}, {'measure': 'BDNF', 'timeFrame': '"0 minutes" "60 minutes" "90 minutes"', 'description': 'regulators of neurogenesis'}, {'measure': 'IGF-1', 'timeFrame': '"0 minutes" "60 minutes" "90 minutes"', 'description': 'regulators of neurogenesis'}, {'measure': 'VEGF', 'timeFrame': '"0 minutes" "60 minutes" "90 minutes"', 'description': 'regulators of neurogenesis'}, {'measure': 'Irisin', 'timeFrame': '"0 minutes" "60 minutes" "90 minutes"', 'description': 'regulators of neurogenesis'}, {'measure': 'Hcy', 'timeFrame': '"0 minutes" "60 minutes" "90 minutes"', 'description': 'homocysteine (Hcy) increase with age and resulted in cognitive function decline through greater oxidative stress and vascular dysfunction'}], 'secondaryOutcomes': [{'measure': 'Reactive time', 'timeFrame': '"0 minutes" "60 minutes" "90 minutes"', 'description': 'Reaction time is the time it takes for the body to go from receiving a stimulus to responding to an action'}, {'measure': 'Accuracy rate', 'timeFrame': '"0 minutes" "60 minutes" "90 minutes"', 'description': 'Accuracy refers to the correct degree of expression or description of a thing, which is used to reflect the correct answer to the thing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurotrophic growth factors', 'IGF-1', 'BDNF', 'VEGF', 'Irisin', 'Hcy'], 'conditions': ['Cognitive Function']}, 'descriptionModule': {'briefSummary': 'The goal of this clinial trial study is to explore the effect of high or low intensity resistance training (LIRT) under similar training volume on change in serum levels of BDNF, IGF-1, VEGF, irisin, and plasma Hcy in young adults.The main questions it aims to answer are:\n\n1. Whether high and low intensity will increase the serum levels of BDNF, IGF-1, VEGF, irisin, and reduce plasma Hcy.\n2. whether a greater magnitude of change would be suffer in low intensity group when compared to high intensity group, as an effect of greater physiological adaptation produced by more repetitions required to complete.\n\nParticipants will performe two different intensity resistance training (HIRT, at 80%1RM with 12 repetitions and 4-5 sets and LIRT, at 40%1RM with 24 repetitions and 4-5 sets).\n\nResearchers will compare the training effects of two different training on these growth factors.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 to 30 years\n* no experiencing musculoskeletal disorders or sports injuries\n* had not participated any regular aerobic endurance or resistance training with in the previous half years\n* no smoking habit or intake alcohol and other medication (e.g., steroid hormone)\n* good general body condition without any chronic diseases (e.g., osteoarthritis, metabolic syndrome or arthritis)\n\nExclusion Criteria:\n\n* experiencing musculoskeletal disorders or sports injuries in recent 1 month\n* had regular resistance training exercise\n* intake any supplementary(drug and hormone)'}, 'identificationModule': {'nctId': 'NCT06114550', 'briefTitle': 'Resistance Training on Growth Factors', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Acute Effect of Resistance Training With Different Intensity on Circulating Levels of Neurotrophic Growth Factors and Homocysteine in Young Adults', 'orgStudyIdInfo': {'id': 'zuochongwen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity resistance training group (HIRT)', 'description': 'All subjects were instructed to conduct HIRT consisted of 4-5 sets of 12 repetitions at 80%1RM, with 1-2 minutes rests between each set.', 'interventionNames': ['Other: High intensity resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'low-intensity resistance training group (LIRT)', 'description': 'All subjects were instructed to conduct LIRT consisted of 4-5 sets of 24 repetitions at 40%1RM, with same period) in random order.', 'interventionNames': ['Other: Low intensity resistance training']}], 'interventions': [{'name': 'High intensity resistance training', 'type': 'OTHER', 'description': 'The HIRT protocol comprised five exercises (bench press, barbell back squat, deadlift, seated leg flexion, and reverse arm curl) at 80% of 1RM, and 4-5 sets of 12 repetitions with 1-2 minutes of rest period between sets for approximately 60 minutes.', 'armGroupLabels': ['High-intensity resistance training group (HIRT)']}, {'name': 'Low intensity resistance training', 'type': 'OTHER', 'description': 'For LIRT protocol, which performed same training exercises as HIRT. The repetitions in the LIRT protocol were assessed using the following equation: 80% of 1RM lifting load (kg) ×repetitions (HIRT)/40% of 1RM to volition fatigue, with 1-2 minutes of rest period between sets. Therefore, the LIRT protocol completed 4-5 sets of 24 repetitions at 40% of 1RM for a total of 60 minutes.', 'armGroupLabels': ['low-intensity resistance training group (LIRT)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chongwen Zuo, Doctoral', 'role': 'CONTACT', 'email': 'zuochongwen@cupes.edu.cn', 'phone': '+86 18810716505'}], 'overallOfficials': [{'name': 'chongwen zuo, Doctoral', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Air Force Medical Center of Chinese PLA'}]}, 'ipdSharingStatementModule': {'url': 'http://www.medresman.org.cn', 'infoTypes': ['SAP'], 'timeFrame': 'When this study was published.', 'ipdSharing': 'YES', 'description': 'The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation, to any qualified researcher. First author should be contacted if someone wants to request the data from this study.', 'accessCriteria': 'Shall not be used for secondary analysis or repeated publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral', 'investigatorFullName': 'Chongwen Zuo', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}