Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000967280
Ethics application status
Approved
Date submitted
20/10/2009
Date registered
9/11/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of exercise on older adults with type 2 diabetes
Scientific title
Differential effect of aerobic versus progressive resistance training on metabolic profile and fitness in older adults with diabetes mellitus
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 251987 0
Condition category
Condition code
Metabolic and Endocrine 252179 252179 0 0
Diabetes
Physical Medicine / Rehabilitation 252180 252180 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progressive resistance training
1 hour session, 3 times a week with a Physiotherapist for 8 weeks
9 resistive exercises at 3 sets of 10 repetitions
Intervention code [1] 241399 0
Lifestyle
Comparator / control treatment
Aerobic training
1 hour session, 3 times a week with a Physiotherapist for 8 weeks
2 aerobic exercises, either cycling, treadmill or cross trainer
Control group
Active

Outcomes
Primary outcome [1] 253050 0
Glycated haemoglobin (Hba1c) and Fasting glucose using blood analysis
Timepoint [1] 253050 0
2 months post training
Primary outcome [2] 253051 0
Cardiovascular fitness using modified Bruce protocol on a treadmill
Timepoint [2] 253051 0
2 months post training
Secondary outcome [1] 257870 0
Anthropometric measurements using measuing tape, weighing scale and bioimpedance machine.
Timepoint [1] 257870 0
2 months post training
Secondary outcome [2] 257871 0
Lipid profile using blood analysis
Timepoint [2] 257871 0
2 months post training

Eligibility
Key inclusion criteria
50 years and above, with Hba1c between 8 to 10 % in the past one month, with the ability to continuously walk for at least 20 minutes and climb one flight of stairs without stopping and unaid
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) uncontrolled diabetes mellitus with Hba1c more than 10% or if escalation of treatment of glycemic control or dyslipidemia is likely to be necessary over the 3 months training period, b) congestive cardiac failure, unstable angina or acute myocardial infarction within the last one year, c) proliferative diabetic retinopathy, d) uncontrolled hypertension, e) advanced arthritis limiting mobility or participation in prescribed exercises, f) respiratory problems such as asthma and chronic obstructive lung disease, g) significant proteinuria or chronic renal insufficiency h) received drugs for the treatment of obesity or very low caloric diet (VLCD, less than 1000 kcal/ deay), i) renal disease and j)were unable to monitor glucose level or comply with exercise program

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by contacting the holder of the allocation sequence/schedule who is located off site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/12/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2263 0
Singapore
State/province [1] 2263 0
Singapore

Funding & Sponsors
Funding source category [1] 243859 0
Government body
Name [1] 243859 0
National Medical Research Council
Country [1] 243859 0
Singapore
Primary sponsor type
Individual
Name
Ng Li Whye Cindy
Address
Physiotherapy Department
Block 1 level 1
Singapore General Hospital
Outram Road
S169608
Country
Singapore
Secondary sponsor category [1] 251252 0
None
Name [1] 251252 0
Address [1] 251252 0
Country [1] 251252 0
Other collaborator category [1] 890 0
Hospital
Name [1] 890 0
Singapore General Hospital
Address [1] 890 0
Outram Road
Singapore 169608
Country [1] 890 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243982 0
SGH Institutional Review Board
Ethics committee address [1] 243982 0
Ethics committee country [1] 243982 0
Singapore
Date submitted for ethics approval [1] 243982 0
Approval date [1] 243982 0
11/12/2002
Ethics approval number [1] 243982 0
IRB 253/2002

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30375 0
Address 30375 0
Country 30375 0
Phone 30375 0
Fax 30375 0
Email 30375 0
Contact person for public queries
Name 13622 0
Ng Li Whye Cindy
Address 13622 0
Physiotherapy Department
Block 1 Level 1
Singapore General Hospital
Outram Road
S169608
Country 13622 0
Singapore
Phone 13622 0
+6581252960
Fax 13622 0
Email 13622 0
[email protected]
Contact person for scientific queries
Name 4550 0
Ng Li Whye Cindy
Address 4550 0
Physiotherapy Department
Block 1 Level 1
Singapore General Hospital
Outram Road
S169608
Country 4550 0
Singapore
Phone 4550 0
+6581252960
Fax 4550 0
Email 4550 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.