Back to resultsEffects of Different Mode of Exercise Training on Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Aerobic Training
Progressive resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes mellitus, Randomized control trial, Exercise, Hemoglobin A, Glycosylated
Eligibility 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.
Sites / Locations
- Singapore General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Aerobic Training
Progressive Resistance Training
Arm Description
50 minutes of aerobic training, 18 sessions within 2 months period
50 minutes of progressive resistance training consisting of nine resistance exercises, each conducted 3 sets of 10 repetitions. 18 sessions over 2 months period.
Outcomes
Primary Outcome Measures
Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage
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
Modified Bruce protocol on a treadmill using Cosmed K4B2 machine to measure
Anthropometric measurements
weight (kilogram), height (metres), body mass index (BMI), waist circumference (centimeters) and body fat (percentage). Measurements to be taken before and after intervention.
Cholesterol
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.
Full Information
NCT ID
NCT01000519
First Posted
October 20, 2009
Last Updated
February 8, 2017
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01000519
Brief Title
Effects of Different Mode of Exercise Training on Type 2 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes mellitus, Randomized control trial, Exercise, Hemoglobin A, Glycosylated
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Training
Arm Type
Active Comparator
Arm Description
50 minutes of aerobic training, 18 sessions within 2 months period
Arm Title
Progressive Resistance Training
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Aerobic Training
Other Intervention Name(s)
Treadmill, Cross trainer, Cycling
Intervention Description
18 sessions over 2 months period. Each session consist of 50 minutes of aerobic training at 65-70 % of maximum predicted heart rate
Intervention Type
Other
Intervention Name(s)
Progressive resistance training
Other Intervention Name(s)
Weight training, Circuit training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Peak volume of oxygen consumed (VO2peak) or fitness level. Measuring unit: ml/kg/min
Description
Modified Bruce protocol on a treadmill using Cosmed K4B2 machine to measure
Time Frame
2 months
Title
Anthropometric measurements
Description
weight (kilogram), height (metres), body mass index (BMI), waist circumference (centimeters) and body fat (percentage). Measurements to be taken before and after intervention.
Time Frame
2 months
Title
Cholesterol
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Whye Cindy Ng
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
11559268
Citation
Boule NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effects of exercise on glycemic control and body mass in type 2 diabetes mellitus: a meta-analysis of controlled clinical trials. JAMA. 2001 Sep 12;286(10):1218-27. doi: 10.1001/jama.286.10.1218.
Results Reference
background
PubMed Identifier
19675378
Citation
Arora E, Shenoy S, Sandhu JS. Effects of resistance training on metabolic profile of adults with type 2 diabetes. Indian J Med Res. 2009 May;129(5):515-9.
Results Reference
background
PubMed Identifier
21810269
Citation
Ng CL, Tai ES, Goh SY, Wee HL. Health status of older adults with Type 2 diabetes mellitus after aerobic or resistance training: a randomised trial. Health Qual Life Outcomes. 2011 Aug 2;9:59. doi: 10.1186/1477-7525-9-59.
Results Reference
derived
PubMed Identifier
20795922
Citation
Ng CL, Goh SY, Malhotra R, Ostbye T, Tai ES. Minimal difference between aerobic and progressive resistance exercise on metabolic profile and fitness in older adults with diabetes mellitus: a randomised trial. J Physiother. 2010;56(3):163-70. doi: 10.1016/s1836-9553(10)70021-7.
Results Reference
derived
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Effects of Different Mode of Exercise Training on Type 2 Diabetes
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