- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01387334
The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients (RE)
June 30, 2011 updated by: Prince of Songkla University
The Effectiveness of a Home-Based Resistance Exercise Training Program With Rubber Bands for Glycemic Control in Individuals With Type 2 Diabetes Mellitus
Resistance exercise is effective in improving glycemic control in diabetes patients.
The effectiveness of a home-based resistance exercise program has not been establish.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Songkhla
-
Hat Yai, Songkhla, Thailand, 90110
- Prince of Songkla University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resistance Exercise Training Program
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compliance of home-based resistive exercise training
Time Frame: 3 years
|
The home visit and telephone call was done to follow up the compliance of home-based resistive exercise training during 3 years.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thanitha Sirirak, MD, Department of Community Medicine, Faculty of Medicine, Prince of Songkla University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
June 13, 2011
First Submitted That Met QC Criteria
June 30, 2011
First Posted (Estimate)
July 4, 2011
Study Record Updates
Last Update Posted (Estimate)
July 4, 2011
Last Update Submitted That Met QC Criteria
June 30, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prince of Songkla University
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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