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

This study has been completed.
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01387334
First received: June 13, 2011
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
 Behavioral: Resistance Exercise Training Program With Rubber Bands
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • compliance of home-based resistive exercise training [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    The home visit and telephone call was done to follow up the compliance of home-based resistive exercise training during 3 years.


Enrollment: 60
Study Start Date: February 2007
Study Completion Date: April 2011
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 13, 2011
Last Updated: June 30, 2011
Health Authority: Thailand: Ministry of Public Health

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

ClinicalTrials.gov processed this record on May 16, 2013