Clinical trial NCT01000519: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus
Randomized control trial
Exercise
Hemoglobin A, Glycosylated
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage
timeFrame: 2 months
Secondary outcomes:
measure: Peak volume of oxygen consumed (VO2peak) or fitness level. Measuring unit: ml/kg/min
timeFrame: 2 months
measure: Anthropometric measurements
timeFrame: 2 months
measure: Cholesterol
timeFrame: 2 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Li Whye Cindy Ng
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.