Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000395336
Ethics application status
Approved
Date submitted
25/06/2008
Date registered
5/08/2008
Date last updated
5/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using Exercise Bands to Provide Physical Activity for People with Diabetes and Poor Mobility
Scientific title
The Effect of Using Exercise Bands to Provide Physical Activity for People with Diabetes and Poor Mobility
Secondary ID [1] 663 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 3314 0
Condition category
Condition code
Metabolic and Endocrine 3474 3474 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The resistance training program comprised four upper body and three lower body exercises using exercise bands, for 30 minutes/day for 4 months. The resistance exercises performed were chest press, seated back rows, leg abductions, leg extension, seated leg press, triceps extensions, and biceps curls. Leg abduction and leg extension were performed using body weight as resistance.
Intervention code [1] 3053 0
Lifestyle
Comparator / control treatment
No specific intervention was administered to the control subjects. They were advised to perform their usual activities and take their usual medication.
Control group
Active

Outcomes
Primary outcome [1] 4376 0
The amount of glycosylated hemoglobin in blood measured by HbA1c
Timepoint [1] 4376 0
Baseline and at 4 months
Secondary outcome [1] 7383 0
anthropometry: body mass index, waist and hip circumference
Timepoint [1] 7383 0
Baseline and at 4 months
Secondary outcome [2] 7384 0
Medical Outcomes Study 36 Item Short Form Health Survey (SF-36) to assess quality of life
Timepoint [2] 7384 0
Baseline and at 4 months

Eligibility
Key inclusion criteria
physically sedentary due to co-morbidities
stable type 2 diabetes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
recent change in medications

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not 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
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3517 0
Commercial sector/Industry
Name [1] 3517 0
Novo-Nordisk Regional Diabetes Support Scheme
Country [1] 3517 0
Australia
Primary sponsor type
Individual
Name
NW Cheung
Address
Dept of Diabetes & Endocrinology
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 3157 0
None
Name [1] 3157 0
Address [1] 3157 0
Country [1] 3157 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5554 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 5554 0
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Ethics committee country [1] 5554 0
Australia
Date submitted for ethics approval [1] 5554 0
08/11/2006
Approval date [1] 5554 0
13/03/2007
Ethics approval number [1] 5554 0
2007/2/4.21(2514)

Summary
Brief summary
This is a randomised controlled trial of a home-based resistance training program using resistance exercise bands, for people with type 2 diabetes who are limited in their ability to perform aerobic exercise due to other co-morbidities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28700 0
Address 28700 0
Country 28700 0
Phone 28700 0
Fax 28700 0
Email 28700 0
Contact person for public queries
Name 11857 0
NW Cheung
Address 11857 0
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country 11857 0
Australia
Phone 11857 0
02 98455555
Fax 11857 0
Email 11857 0
[email protected]
Contact person for scientific queries
Name 2785 0
NW Cheung
Address 2785 0
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country 2785 0
Australia
Phone 2785 0
02 9845 5555
Fax 2785 0
Email 2785 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.