Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-07 @ 7:50 PM
Study NCT ID:
NCT03280758
Status:
UNKNOWN
Last Update Posted:
2017-09-12
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Strength Training for Older Adults With Type II Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor will not know the intervention of each subjects'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting glucose level', 'timeFrame': '4 months'}, {'measure': 'Lipid profiles', 'timeFrame': '4 months', 'description': 'HDL, LDL, Trig'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '4 months', 'description': 'Whole body'}, {'measure': 'Muscle mass', 'timeFrame': '4 months', 'description': 'Whole body'}, {'measure': 'Functional performance', 'timeFrame': '4 months', 'description': 'Walking ability'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resistance training', 'Diabetes Mellitus', 'blood-glucose control', 'Muscle', 'Function'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21705072', 'type': 'BACKGROUND', 'citation': 'Nolan CJ, Damm P, Prentki M. Type 2 diabetes across generations: from pathophysiology to prevention and management. Lancet. 2011 Jul 9;378(9786):169-81. doi: 10.1016/S0140-6736(11)60614-4. Epub 2011 Jun 24.'}, {'pmid': '23537893', 'type': 'BACKGROUND', 'citation': 'Leenders M, Verdijk LB, van der Hoeven L, Adam JJ, van Kranenburg J, Nilwik R, van Loon LJ. Patients with type 2 diabetes show a greater decline in muscle mass, muscle strength, and functional capacity with aging. J Am Med Dir Assoc. 2013 Aug;14(8):585-92. doi: 10.1016/j.jamda.2013.02.006. Epub 2013 Mar 26.'}, {'pmid': '24420336', 'type': 'BACKGROUND', 'citation': 'Shishikura K, Tanimoto K, Sakai S, Tanimoto Y, Terasaki J, Hanafusa T. Association between skeletal muscle mass and insulin secretion in patients with type 2 diabetes mellitus. Endocr J. 2014;61(3):281-7. doi: 10.1507/endocrj.ej13-0375. Epub 2014 Jan 10.'}, {'pmid': '12351469', 'type': 'BACKGROUND', 'citation': 'Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.'}, {'pmid': '12017678', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.'}, {'pmid': '10912903', 'type': 'BACKGROUND', 'citation': 'Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.'}, {'pmid': '20093961', 'type': 'BACKGROUND', 'citation': 'Black LE, Swan PD, Alvar BA. Effects of intensity and volume on insulin sensitivity during acute bouts of resistance training. J Strength Cond Res. 2010 Apr;24(4):1109-16. doi: 10.1519/JSC.0b013e3181cbab6d.'}, {'pmid': '12905089', 'type': 'BACKGROUND', 'citation': 'Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.'}]}, 'descriptionModule': {'briefSummary': 'This randomised controlled trial aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).\n\n60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.\n\nMuscle strengthening group will receive resistance training 3 times per week (1 hour/session).\n\nThe control group will not receive any training but can continue usual medical care and daily activities.\n\nPrimary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and strength, and functional capacity Data will be collected at baseline (pre-test) and after a 4-month intervention (post-test).', 'detailedDescription': 'This study aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).\n\nThis is a single-blinded, randomized controlled trial. 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.\n\nInformation on demographic characteristics, body composition, muscle strength, functional capacity and glycemic control will be collected at baseline (pre-test) and after a 4-month intervention (post-test). Muscle strengthening group will receive resistance training 3 times per week (1 hour/session).\n\nThe control group will not receive any training but can continue usual medical care and daily activities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T2 DM\n* 60-75 years old\n* ability to perform exercise\n\nExclusion Criteria:\n\n* Advanced hypertension (≥ 160/100 mm Hg)\n* severe obesity (BMI ≥ 48kg/m2)\n* insulin pump user\n* coronary heart disease history\n* chronic obstructive pulmonary disease\n* advanced neuropathy\n* learning or mental disorder, or\n* any other diseases that prevent subjects from exercising safely.\n* Those who participate in regular resistance or aerobic exercises will also be excluded.'}, 'identificationModule': {'nctId': 'NCT03280758', 'briefTitle': 'Muscle Strength Training for Older Adults With Type II Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Effects of Muscle Strength Training on Glycemic Control, Muscle Mass, Muscle Strength and Functional Capacity in Older Adults With Type II Diabetes: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscle strengthening group', 'description': 'Participants will be required to perform muscle strengthening exercises 3 hours per week. Close kinetic chain exercises will be performed progressively according to the ACSM guidelines over the 4-month intervention period. The exercise intervention will be conducted by an experienced sports trainer.', 'interventionNames': ['Behavioral: Muscle Strengthening exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No exercise training.'}], 'interventions': [{'name': 'Muscle Strengthening exercises', 'type': 'BEHAVIORAL', 'description': 'Participants will be required to participate in resistance training 3 hours per week.', 'armGroupLabels': ['Muscle strengthening group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Siu Ming Fong, PhD', 'role': 'CONTACT', 'email': 'smfong@hku.hk', 'phone': '28315260'}], 'overallOfficials': [{'name': 'Siu Ming Fong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Shirley S.M. Fong', 'investigatorAffiliation': 'The University of Hong Kong'}}}}