Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-28 @ 10:26 PM
Study NCT ID:
NCT01387334
Status:
COMPLETED
Last Update Posted:
2011-07-04
First Post:
2011-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2011-06-13', 'studyFirstSubmitQcDate': '2011-06-30', 'lastUpdatePostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'compliance of home-based resistive exercise training', 'timeFrame': '3 years', 'description': 'The home visit and telephone call was done to follow up the compliance of home-based resistive exercise training during 3 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['resistive exercise', 'Resistance Exercise Training Program', 'Rubber Bands', 'Glycemic Control', 'Type 2 Diabetes Mellitus'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Resistance exercise is effective in improving glycemic control in diabetes patients. The effectiveness of a home-based resistance exercise program has not been establish.', 'detailedDescription': 'Exercise play an important role in diabetes control. The American Diabetes Association (ADA) approved of resistive exercise as an effective method in controlling blood sugar of type 2 diabetes patients. Few community-based intervention has been establish. So the authors developed the low-cost community based resistance exercise program to promote exercise in of type 2 diabetes patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes was diagnosed by physician using fasting plasma glucose not less than 126 mg/dl and/or HbA1c not less than 7 %.\n* Type 2 diabetes was diagnosed at least 6 months previously.\n* The subject was ongoing treatment in primary care unit of prince of Songkla University.\n\nExclusion Criteria:\n\n* Gestational diabetes and type 1 diabetes patients\n* History of cardiovascular disease within the pass 6 months or any unstable chronic condition including dementia, proliferative diabetic retinopathy, retinal hemorrhage or detachment, dialysis and diabetic foot patients.'}, 'identificationModule': {'nctId': 'NCT01387334', 'acronym': 'RE', 'briefTitle': 'The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'The Effectiveness of a Home-Based Resistance Exercise Training Program With Rubber Bands for Glycemic Control in Individuals With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'Prince of Songkla University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance Exercise Training Program', 'interventionNames': ['Behavioral: Resistance Exercise Training Program With Rubber Bands']}], 'interventions': [{'name': 'Resistance Exercise Training Program With Rubber Bands', 'type': 'BEHAVIORAL', 'otherNames': ['elastic band'], 'description': 'Resistive exercise consist of 5-min warm up, at least 30 min resistive exercise using rubber band as recommendation (8-12 times per set, at least 3 sets per day and at least 3 days per week) and 5-min cool down', 'armGroupLabels': ['Resistance Exercise Training Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Prince of Songkla University', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'overallOfficials': [{'name': 'Thanitha Sirirak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Community Medicine, Faculty of Medicine, Prince of Songkla University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Department of Community Medicine', 'oldOrganization': 'Faculty of Medicine, Prince of Songkla University'}}}}