Diabetes Mellitus, Type 2NCT01000519
Effects of Different Mode of Exercise Training on Type 2 Diabetes
A study testing Aerobic Training and Progressive resistance training in people with Diabetes Mellitus, Type 2, run by Singapore General Hospital at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Aerobic Training and Progressive resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2002to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Aerobic Training, Progressive resistance training
- Keywords
- Diabetes mellitus, Randomized control trial, Exercise, Hemoglobin A, Glycosylated
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic TrainingOther
Also called Treadmill, Cross trainer, Cycling
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 trainingOther
Also called Weight training, Circuit 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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Training | Active comparator | 50 minutes of aerobic training, 18 sessions within 2 months period Receives: Other: Aerobic Training |
| Progressive Resistance Training | Experimental | 50 minutes of progressive resistance training consisting of nine resistance exercises, each conducted 3 sets of 10 repetitions. 18 sessions over 2 months period. Receives: Other: Progressive resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (3)
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
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startDec 2002
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Whye Cindy Ng, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000519
- Sponsor's protocol ID
- NMRC/0728/2003
- Status last verified
- Feb 2017
- First submitted
- 20 Oct 2009
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 11559268Arora 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.
PubMed 19675378Ng 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.
PubMed 21810269Ng 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.
PubMed 20795922
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01000519
- Acronym / sponsor ID
- NMRC/0728/2003
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes mellitus, Randomized control trial, Exercise, Hemoglobin A, Glycosylated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training | Active comparator | Other: Aerobic Training50 minutes of aerobic training, 18 sessions within 2 months period |
| Progressive Resistance Training | Experimental | Other: Progressive resistance training50 minutes of progressive resistance training consisting of nine resistance exercises, each conducted 3 sets of 10 repetitions. 18 sessions over 2 months period. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic TrainingAlso: Treadmill, Cross trainer, Cycling18 sessions over 2 months period. Each session consist of 50 minutes of aerobic training at 65-70 % of maximum predicted heart rate | Other | Aerobic Training |
| Progressive resistance trainingAlso: Weight training, Circuit training18 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 | Progressive Resistance Training |
Primary outcome
Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage
Time frame: 2 months
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.
3 secondary outcomes
Peak volume of oxygen consumed (VO2peak) or fitness level. Measuring unit: ml/kg/min
Time frame: 2 months
Anthropometric measurements
Time frame: 2 months
Cholesterol
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Background: PubMed 11559268Boule 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.
- Background: PubMed 19675378Arora 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.
- Derived from this study: PubMed 21810269Ng 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.
- Derived from this study: PubMed 20795922Ng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Whye Cindy Ng principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training and Progressive resistance training in people with Diabetes Mellitus, Type 2, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A, Glycosylated (Hba1c). Measuring unit: percentage (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000519, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.