- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01000519
Effects of Different Mode of Exercise Training on Type 2 Diabetes
Differential Effects of Aerobic Versus Progressive Resistance Training on Metabolic Profile and Fitness in Older Adults With Diabetes Mellitus - a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 169608
- Singapore General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aerobic Training
50 minutes of aerobic training, 18 sessions within 2 months period
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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:
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage
Time Frame: 2 months
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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.
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak volume of oxygen consumed (VO2peak) or fitness level. Measuring unit: ml/kg/min
Time Frame: 2 months
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Modified Bruce protocol on a treadmill using Cosmed K4B2 machine to measure
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2 months
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Anthropometric measurements
Time Frame: 2 months
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weight (kilogram), height (metres), body mass index (BMI), waist circumference (centimeters) and body fat (percentage).
Measurements to be taken before and after intervention.
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2 months
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Cholesterol
Time Frame: 2 months
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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.
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2 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Li Whye Cindy Ng, Singapore General Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMRC/0728/2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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