Effects of Different Mode of Exercise Training on Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01000519
First received: October 20, 2009
Last updated: March 23, 2010
Last verified: October 2009
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: Aerobic Training
Other: Progressive resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Differential Effects of Aerobic Versus Progressive Resistance Training on Metabolic Profile and Fitness in Older Adults With Diabetes Mellitus - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Peak volume of oxygen consumed (VO2peak) or fitness level. Measuring unit: ml/kg/min [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Modified Bruce protocol on a treadmill using Cosmed K4B2 machine to measure

  • Anthropometric measurements [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: December 2002
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aerobic Training
50 minutes of aerobic training, 18 sessions within 2 months period
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000519

Locations
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Li Whye Cindy Ng Singapore General Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ng Li Whye Cindy, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01000519     History of Changes
Other Study ID Numbers: NMRC/0728/2003
Study First Received: October 20, 2009
Last Updated: March 23, 2010
Health Authority: Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)

Keywords provided by Singapore General Hospital:
Diabetes mellitus
Randomized control trial
Exercise
Hemoglobin A, Glycosylated

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

ClinicalTrials.gov processed this record on July 24, 2014