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The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients (RE)

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ClinicalTrials.gov Identifier: NCT01387334
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : July 4, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Resistance Exercise Training Program With Rubber Bands Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2007
Primary Completion Date : February 2009
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Resistance Exercise Training Program Behavioral: Resistance Exercise Training Program With Rubber Bands
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 Name: elastic band


Outcome Measures

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387334


Locations
Thailand
Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Thanitha Sirirak, MD Department of Community Medicine, Faculty of Medicine, Prince of Songkla University
More Information

Responsible Party: Department of Community Medicine, Faculty of Medicine, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01387334     History of Changes
Other Study ID Numbers: Prince of Songkla University
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: June 2011

Keywords provided by Prince of Songkla University:
resistive exercise
Resistance Exercise Training Program
Rubber Bands
Glycemic Control
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases