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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01000519
Other study ID # NMRC/0728/2003
Secondary ID
Status Completed
Phase N/A
First received October 20, 2009
Last updated February 8, 2017
Start date December 2002
Est. completion date June 2006

Study information

Verified date February 2017
Source Singapore General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2006
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Singapore Singapore General Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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. — View Citation

Boulé 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 months
Secondary 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 2 months
Secondary 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. 2 months
Secondary 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. 2 months
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