Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-30 @ 8:44 AM
Study NCT ID:
NCT06576804
Status:
COMPLETED
Last Update Posted:
2024-08-29
First Post:
2024-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eccentric Cycling Exercise on Mitochondrial Function of Lymphocyte
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mitochondrial function of lymphocyte', 'timeFrame': '12 weeks', 'description': 'Evaluate bioenergetic health index (BHI) of mitochondria in lymphocyte by using a high resolution respirometer.'}], 'secondaryOutcomes': [{'measure': 'Cardiopulmonary fitness', 'timeFrame': '12 weeks', 'description': 'The graded exercise test (GXT) on a bicycle ergometer was performed. The GXT comprised 2 min of unloaded pedaling followed by a continuous increase in the work rate of 30 watt per 3-minute until exhaustion (i.e., progressive exercise to maximal O2 consumption)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eccentric cycling', 'Mitochondria', 'Lymphocyte'], 'conditions': ['Eccentric Exercise Training']}, 'referencesModule': {'references': [{'pmid': '12730250', 'type': 'RESULT', 'citation': 'LaStayo PC, Ewy GA, Pierotti DD, Johns RK, Lindstedt S. The positive effects of negative work: increased muscle strength and decreased fall risk in a frail elderly population. J Gerontol A Biol Sci Med Sci. 2003 May;58(5):M419-24. doi: 10.1093/gerona/58.5.m419.'}, {'pmid': '31130877', 'type': 'RESULT', 'citation': 'Hody S, Croisier JL, Bury T, Rogister B, Leprince P. Eccentric Muscle Contractions: Risks and Benefits. Front Physiol. 2019 May 3;10:536. doi: 10.3389/fphys.2019.00536. eCollection 2019.'}, {'pmid': '33584331', 'type': 'RESULT', 'citation': 'Touron J, Costes F, Coudeyre E, Perrault H, Richard R. Aerobic Metabolic Adaptations in Endurance Eccentric Exercise and Training: From Whole Body to Mitochondria. Front Physiol. 2021 Jan 27;11:596351. doi: 10.3389/fphys.2020.596351. eCollection 2020.'}, {'pmid': '27731374', 'type': 'RESULT', 'citation': 'Tsai HH, Chang SC, Chou CH, Weng TP, Hsu CC, Wang JS. Exercise Training Alleviates Hypoxia-induced Mitochondrial Dysfunction in the Lymphocytes of Sedentary Males. Sci Rep. 2016 Oct 12;6:35170. doi: 10.1038/srep35170.'}]}, 'descriptionModule': {'briefSummary': 'Eccentric cycling exercise (ECE) features lower metabolic demand and higher improvement of muscle strength compared to traditional concentric cycling exercise (CCE). Mitochondria can regulate energy metabolism and adaptive immune quality in T lymphocytes. However, the effects of ECE on mitochondrial functions in T-lymphocytes have not yet been established.\n\nMethod: A total of 33 healthy sedentary males were randomized and divided into ECE (n=11), CCE (n=11), and control groups (n=11). These subjects progressively performed CCE or ECE from 60% to 80% maximal workload on a bicycle ergometer for 40 min/day, 5 days/week for 6 weeks. A graded exercise testing and an isokinetic strength test were conducted to evaluate cardiopulmonary fitness and muscle strength, respectively. Phenotypes and mitochondrial respiratory capacity in T lymphocyte were analyzed using flow cytometry and high-resolution respirometer, respectively.', 'detailedDescription': 'Eccentric exercise training (EET) increases physical performance while having lower metabolic demand than concentric exercise training (CET).\n\nMitochondria of lymphocytes are essential for cell proliferation, death, and differentiation, and play a critical role in establishing lymphocyte phenotypes and their functions.\n\nWhether EET influences lymphocyte bioenergetic efficiency remains unclear. The study was to investigate the effects of ECE and CCE regimens on adaptive immune functions and mitochondrial bioenergetics of T lymphocytes in sedentary males.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sedentary lifestyle.\n2. Nonsmokers, nonusers of medications/vitamins.\n3. No any cardiopulmonary/hematological risks.\n\nExclusion Criteria:\n\n1. Have regular exercise habits (i.e., exercise frequency once per week, duration \\>20 min).\n2. Have retabolic or musculoskeletal disease.'}, 'identificationModule': {'nctId': 'NCT06576804', 'briefTitle': 'Eccentric Cycling Exercise on Mitochondrial Function of Lymphocyte', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Effects of Concentric and Eccentric Exercise Regimens on Bioenergetic Efficiency of Lymphocytes in Sedentary Males', 'orgStudyIdInfo': {'id': '202100004A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eccentric cycling training', 'description': 'Moderate to high intensity cycling training in eccentric type', 'interventionNames': ['Behavioral: Eccentric cycling training']}, {'type': 'EXPERIMENTAL', 'label': 'Concentric cycling training', 'description': 'Moderate to high intensity cycling training in concentric type (intensity matched the eccentric training)', 'interventionNames': ['Behavioral: Concentric cycling training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'without receiving any exercise training'}], 'interventions': [{'name': 'Eccentric cycling training', 'type': 'BEHAVIORAL', 'description': 'Performed exercise training 5 days a week for 6 weeks on an eccentric ergometer.\n\nEach training session: 5 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase.\n\nIntensity: Firstly, set at 60% Wmax, and progressively increased 5% per week', 'armGroupLabels': ['Eccentric cycling training']}, {'name': 'Concentric cycling training', 'type': 'BEHAVIORAL', 'description': 'Performed exercise training 5 days a week for 6 weeks on an eccentric ergometer.\n\nEach training session: 5 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase.\n\nIntensity: Firstly, set at 60% Wmax, and progressively increased 5% per week', 'armGroupLabels': ['Concentric cycling training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung University', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jong-Shyan Wang', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}