Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000336684
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
8/09/2005
Date last updated
21/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stay Active, Strong and Healthy study (SASH)
Scientific title
Evaluation of a community-based strength training model on HbA1c in people with Type 2 diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 429 0
Condition category
Condition code
Metabolic and Endocrine 499 499 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
progressive resistance training for the duration of 12 months
Intervention code [1] 385 0
Treatment: Other
Comparator / control treatment
home based resistance training for the duration of 12 months
Control group
Dose comparison

Outcomes
Primary outcome [1] 571 0
Change in HbA1c between 0, 2, and 14 months
Timepoint [1] 571 0
At 0, 2 and 14 months
Secondary outcome [1] 1212 0
Exercise adherence
Timepoint [1] 1212 0
Changes between 0, 2, and 14 months.
Secondary outcome [2] 1213 0
Insulin and insulin sensitivity
Timepoint [2] 1213 0
Changes between 0, 2, and 14 months.
Secondary outcome [3] 1214 0
Self-monitored glucose
Timepoint [3] 1214 0
Changes between 0, 2, and 14 months.
Secondary outcome [4] 1215 0
Muscle strength
Timepoint [4] 1215 0
Changes between 0, 2, and 14 months.
Secondary outcome [5] 1216 0
Body composition
Timepoint [5] 1216 0
Changes between 0, 2, and 14 months.
Secondary outcome [6] 1217 0
Blood pressure
Timepoint [6] 1217 0
Changes between 0, 2, and 14 months.
Secondary outcome [7] 1218 0
Self-efficacy
Timepoint [7] 1218 0
Changes between 0, 2, and 14 months.
Secondary outcome [8] 1219 0
Quality of life
Timepoint [8] 1219 0
Changes between 0, 2, and 14 months.
Secondary outcome [9] 1220 0
Emotional well being
Timepoint [9] 1220 0
Changes between 0, 2, and 14 months.

Eligibility
Key inclusion criteria
overweight (BMI > 27 < 40kg/m2) males and females, established (>6 months) Type 2 diabetes, not on insulin therapy, HbA1c 7.0 - 10.0%, lifestyle - sedentary and non- smokers.Criteria developed by the American College of Sports Medicine for absolute contraindications to exercise participation were used to assess eligibility for participation.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poorly treated hypertensives (anti-hypertensive medication and BP > 180/95 on at least 2 occasions or untreated hypertensives (BP > 180/95 on at least 2 occasions) were excluded

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)
Sealed envelopes were held by an independent person, and opened by the independent person to assign the intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers (Excel), in blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 562 0
Charities/Societies/Foundations
Name [1] 562 0
VicHealth
Country [1] 562 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
VicHealth
Address
melbourne, VIC
Country
Australia
Secondary sponsor category [1] 455 0
Other
Name [1] 455 0
International Diabetes Institute
Address [1] 455 0
250 Kooyong Rd, Caulfield, VIC
Country [1] 455 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1584 0
International Diabetes Institute Ethics Committee
Ethics committee address [1] 1584 0
Ethics committee country [1] 1584 0
Australia
Date submitted for ethics approval [1] 1584 0
Approval date [1] 1584 0
Ethics approval number [1] 1584 0

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

Contacts
Principal investigator
Name 35258 0
Address 35258 0
Country 35258 0
Phone 35258 0
Fax 35258 0
Email 35258 0
Contact person for public queries
Name 9574 0
Mrs Elena Vulikh
Address 9574 0
International Diabetes Institute
250 Kooyong Rd
Caulfield Melbourne VIC 3162
Country 9574 0
Australia
Phone 9574 0
+61 3 92585000
Fax 9574 0
+61 3 92585902
Email 9574 0
[email protected]
Contact person for scientific queries
Name 502 0
A/Professor Jonathan Shaw
Address 502 0
International Diabetes Institute
250 Kooyong Rd
Caulfield Melbourne VIC 3162
Country 502 0
Australia
Phone 502 0
+61 3 92585000
Fax 502 0
+61 3 92585902
Email 502 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.