Back to resultsThe Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients (RE)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Resistance Exercise Training Program With Rubber Bands
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring resistive exercise, Resistance Exercise Training Program, Rubber Bands, Glycemic Control, Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes was diagnosed by physician using fasting plasma glucose not less than 126 mg/dl and/or HbA1c not less than 7 %.
- Type 2 diabetes was diagnosed at least 6 months previously.
- The subject was ongoing treatment in primary care unit of prince of Songkla University.
Exclusion Criteria:
- Gestational diabetes and type 1 diabetes patients
- 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.
Sites / Locations
- Prince of Songkla University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resistance Exercise Training Program
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
compliance of home-based resistive exercise training
The home visit and telephone call was done to follow up the compliance of home-based resistive exercise training during 3 years.
Full Information
NCT ID
NCT01387334
First Posted
June 13, 2011
Last Updated
June 30, 2011
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT01387334
Brief Title
The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients
Acronym
RE
Official Title
The Effectiveness of a Home-Based Resistance Exercise Training Program With Rubber Bands for Glycemic Control in Individuals With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Resistance exercise is effective in improving glycemic control in diabetes patients. The effectiveness of a home-based resistance exercise program has not been establish.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
resistive exercise, Resistance Exercise Training Program, Rubber Bands, Glycemic Control, Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistance Exercise Training Program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Resistance Exercise Training Program With Rubber Bands
Other Intervention Name(s)
elastic band
Intervention 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
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
3 months
Secondary Outcome Measure Information:
Title
compliance of home-based resistive exercise training
Description
The home visit and telephone call was done to follow up the compliance of home-based resistive exercise training during 3 years.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes was diagnosed by physician using fasting plasma glucose not less than 126 mg/dl and/or HbA1c not less than 7 %.
Type 2 diabetes was diagnosed at least 6 months previously.
The subject was ongoing treatment in primary care unit of prince of Songkla University.
Exclusion Criteria:
Gestational diabetes and type 1 diabetes patients
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thanitha Sirirak, MD
Organizational Affiliation
Department of Community Medicine, Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
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The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients
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