Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT01638351
Status:
COMPLETED
Last Update Posted:
2012-11-16
First Post:
2012-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resistance Training in Diabetic Elder Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'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': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-15', 'studyFirstSubmitDate': '2012-07-08', 'studyFirstSubmitQcDate': '2012-07-08', 'lastUpdatePostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal muscle strength', 'timeFrame': 'Twelve weeks', 'description': 'This outcome measure includes upper and lower body maximal muscle strength.'}], 'secondaryOutcomes': [{'measure': 'Physical body function', 'timeFrame': 'Twelve weeks', 'description': 'This outcome will be assessed by one minute sit-to-stand test and timed "Up and Go" test.'}, {'measure': 'Quality of life', 'timeFrame': 'Twelve weeks', 'description': 'This outcome measure will be assessed by the diabetes-specific questionnaire.'}, {'measure': 'Waist circumference', 'timeFrame': 'Twelve weeks'}, {'measure': 'Body mass index', 'timeFrame': 'Twelve weeks', 'description': 'This outcome measure includes the measurements of body height and body weight.'}, {'measure': 'Functional capacity', 'timeFrame': 'Twelve weeks', 'description': 'Peak oxygen consumption will be determined by graded exercise test to assess functional capacity.'}, {'measure': 'Blood biochemical parameters', 'timeFrame': 'Twevle weeks', 'description': 'This outcome measure includes the analysis of fasting glucose, glycated hemoglobin, lipid profile, C-reactive protein, and related metabolites.'}, {'measure': 'Muscle oxygenation', 'timeFrame': 'Twelve weeks', 'description': 'Muscle oxygenation will be assessed during exercise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Resistance exercise', 'Elderly', 'Skeletal muscle dysfunction', 'Metabolomics'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '12453982', 'type': 'BACKGROUND', 'citation': 'Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41. doi: 10.2337/diacare.25.12.2335.'}, {'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': '12902533', 'type': 'BACKGROUND', 'citation': 'Brandon LJ, Gaasch DA, Boyette LW, Lloyd AM. Effects of long-term resistive training on mobility and strength in older adults with diabetes. J Gerontol A Biol Sci Med Sci. 2003 Aug;58(8):740-5. doi: 10.1093/gerona/58.8.m740.'}, {'pmid': '19157617', 'type': 'BACKGROUND', 'citation': 'Cheung NW, Cinnadaio N, Russo M, Marek S. A pilot randomised controlled trial of resistance exercise bands in the management of sedentary subjects with type 2 diabetes. Diabetes Res Clin Pract. 2009 Mar;83(3):e68-71. doi: 10.1016/j.diabres.2008.12.009. Epub 2009 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of a 12-week progressive resistance training program on the skeletal muscle function, glycemic control, functional capacity, and quality of life in the elderly with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years old or older\n* no clinical diagnosis of cardiovascular disease\n* patients with or without type 2 diabetes mellitus\n\nExclusion Criteria:\n\n* glycated hemoglobin \\> 10%\n* pulmonary disease\n* cancer\n* cognitive dysfunction\n* any neurological or musculoskeletal disease that will affect exercise performance'}, 'identificationModule': {'nctId': 'NCT01638351', 'briefTitle': 'Resistance Training in Diabetic Elder Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Resistance Training on Muscle Dysfunction in Elderly Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '201110029RC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.', 'interventionNames': ['Behavioral: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Resistance exercise', 'description': 'Progressive resistance training, 3 times a week for 12 weeks', 'interventionNames': ['Behavioral: Resistance exercise']}], 'interventions': [{'name': 'Resistance exercise', 'type': 'BEHAVIORAL', 'description': 'Progressive resistance exercise training, 3 times a week for 12 weeks.', 'armGroupLabels': ['Resistance exercise']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ying-Tai Wu, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University (R.O.C.)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}