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Effects of Different Mode of Exercise Training on Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01000519
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Tracking Information
First Submitted Date  ICMJE October 20, 2009
First Posted Date  ICMJE October 23, 2009
Last Update Posted Date February 10, 2017
Study Start Date  ICMJE December 2002
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage [ Time Frame: 2 months ]
Blood was drawn from each subject who fasted at least 10 hours overnight. Hba1c (%) was measured using high performance liquid chromatography (HPLC Variant II Bio Rad Laboratories, Munich, Germany). Change in Hba1c before and after intervention were looked at.
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
Hemoglobin A, Glycosylated (Hba1c), measured by a blood test. Change in Hba1c before and after intervention. Measuring unit: percentage [ Time Frame: 2 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
  • Peak volume of oxygen consumed (VO2peak) or fitness level. Measuring unit: ml/kg/min [ Time Frame: 2 months ]
    Modified Bruce protocol on a treadmill using Cosmed K4B2 machine to measure
  • Anthropometric measurements [ Time Frame: 2 months ]
    weight (kilogram), height (metres), body mass index (BMI), waist circumference (centimeters) and body fat (percentage). Measurements to be taken before and after intervention.
  • Cholesterol [ Time Frame: 2 months ]
    Blood was drawn from each subject who fasted at least 10 hours overnight. Total cholesterol and triglycerides (TG) were measured using enzymatic colorimetric methods with cholesterol oxidase-peroxidase amino phenazone phenol and glycerol-3-phospahte oxidase-peroxidase amino phenazone phenol. High-density lipoprotein cholesterol (HDL-C) was measured using homogenous enzymatic colorimetric assay. Low-density lipoprotein cholesterol (LDL-C) was calculated using the Friedewald formula.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2009)
  • Peak volume of oxygen consumed (VO2peak) or fitness level before and after intervention, using the Bruce protocol on a treadmill. Measuring unit: ml/kg/min [ Time Frame: 2 months ]
  • Anthropometric measurements, namely weight (kilogram), body mass index (BMI), waist circumference (centimeters) and body fat (percentage). Measurements to be taken before and after intervention. [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Different Mode of Exercise Training on Type 2 Diabetes
Official Title  ICMJE Differential Effects of Aerobic Versus Progressive Resistance Training on Metabolic Profile and Fitness in Older Adults With Diabetes Mellitus - a Randomized Controlled Trial
Brief Summary Randomized study on the comparison between aerobic training versus progressive resistance training over a 2 months period for older adults with type 2 diabetes. The hypothesis is that progressive resistance training is just as effective as aerobic training on Hba1c and could be an alternative training for those older diabetic patients who cannot participate in aerobic exercise.
Detailed Description

Many studies have shown the importance of aerobic training with respect to management of diabetes. However adoption of aerobic activities may be challenging for some individuals with diabetes, especially the elderly and the obese. There is increasing interest in resistance training and no study have looked at direct comparison between the two.

Subjects with diabetes but is generally sedentary (determined by means of a questionnaire) were recruited and randomized in one of the two groups. Subjects are supervised in a group and a completer is defined as one who completed 18 sessions within 8 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Other: Aerobic Training
    18 sessions over 2 months period. Each session consist of 50 minutes of aerobic training at 65-70 % of maximum predicted heart rate
    Other Names:
    • Treadmill
    • Cross trainer
    • Cycling
  • Other: Progressive resistance training
    18 sessions completed in 2 months. each session consists of 50 minutes of resistance training which is made up of 3 sets of 10 repetitions of nine resistive exercises using machines and free weights at 65-70% of 1-repetitive maximum.
    Other Names:
    • Weight training
    • Circuit training
Study Arms  ICMJE
  • Active Comparator: Aerobic Training
    50 minutes of aerobic training, 18 sessions within 2 months period
    Intervention: Other: Aerobic Training
  • Experimental: Progressive Resistance Training
    50 minutes of progressive resistance training consisting of nine resistance exercises, each conducted 3 sets of 10 repetitions. 18 sessions over 2 months period.
    Intervention: Other: Progressive resistance training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2009)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged 50 years and above,
  • Hba1c between 8 to 10 % in the past one month,
  • sedentary,
  • able to continuously walk for at least 20 minutes and climbed one flight of stairs unaided without stopping were eligible for participation.

Exclusion Criteria:

  • uncontrolled diabetes mellitus with Hba1c more than 10% or if escalation of treatment of glycemic control or dyslipidemia was likely to be necessary over the 2 months training period period,
  • congestive cardiac failure, unstable angina or acute myocardial infarction within the last one year,
  • proliferative diabetic retinopathy,
  • uncontrolled hypertension,
  • advanced arthritis likely to limit mobility or participation in prescribed exercises,
  • respiratory conditions such as asthma and chronic obstructive lung disease,
  • significant proteinuria or chronic renal insufficiency,
  • received drugs for the treatment of obesity or very low caloric diet (VLCD, less than 1000 kcal/ day),
  • renal disease and
  • inability to monitor glucose level or comply with exercise program.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000519
Other Study ID Numbers  ICMJE NMRC/0728/2003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Singapore General Hospital
Study Sponsor  ICMJE Singapore General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li Whye Cindy Ng Singapore General Hospital
PRS Account Singapore General Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP