Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000131257
Ethics application status
Not yet submitted
Date submitted
12/01/2009
Date registered
23/02/2009
Date last updated
4/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is resistance training beneficial for female adults with Type 2 diabetes?
Scientific title
An investigation into the effect of a supervised and home-based resistance training program on lower limb strength and sensation in female adults with Type 2 Diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The health condition studied was Type 2 Diabetes, more specifically blood glucose control, lower limb strength and proprioception in the lower limbs. 4185 0
Condition category
Condition code
Metabolic and Endocrine 4394 4394 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve resistance training exercise using machine, free weights, body weight and resistance band exercises. There will be 2 x 60 minute sessions weekly for 16 weeks. Weeks 1-12 will be supervised by a qualified exercise scientist and and weeks 13-16 will be home based using only resistance bands and body weight exercises. Each session will involve 8 exercises aiming for 70-90% of the individual 1-repetition maximum or 7-9 on Borgs category-ratio rate of percieved exertion with 1-4 sets of 4-14 repetitions.
Intervention code [1] 3903 0
Rehabilitation
Comparator / control treatment
No treatment (daily activities)
Control group
Active

Outcomes
Primary outcome [1] 5272 0
Knee flexion/extension isokinetic peak torque using KinCom Dynamometer
Timepoint [1] 5272 0
Taken at baseline, 12 and 16 weeks on all participants
Primary outcome [2] 5273 0
Propriception in the lower limb - Sensation using a Semmes-Weinstein monofilaments on the plantar and dorsal surface of the foot
Timepoint [2] 5273 0
Taken at baseline, 12 and 16 weeks on all participants
Primary outcome [3] 5274 0
Propriception in the lower limb - Vibration Perception Threshold using a Biothesiometer on plantar surface of the foot
Timepoint [3] 5274 0
Taken at baseline, 12 and 16 weeks on all participants
Secondary outcome [1] 8887 0
Lower limb Isotonic Strength using One-repetition maximum technique
Timepoint [1] 8887 0
Taken at baseline, 4, 8, 12 and 16 weeks on all participants
Secondary outcome [2] 8888 0
Long term blood glycaemic control will be measured using Glycosylated hemoglobin (HbA1c). Blood will be taken by participants general practioner and labratory results will be fowarded to the researchers.
Timepoint [2] 8888 0
Taken at baseline, 12 and 16 weeks on all participants

Eligibility
Key inclusion criteria
Participants must be female aged between 60-80 years who have been diagnosed with Type 2 diabetes for greater than 6 months.
Blood glucose levels must be currently controlled by a combination of diet, exercise and/or oral hypoglycemic agents and all participants must have access to a mobile phone to receive and send SMS text messages. Participants will also be required to gain medical clearance from a General Practioner and undertake a HbA1c (Glycosylated hemoglobin) test before and after the program.
Minimum age
60 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from participation in the study if they have participated in a supervised resistance training program (2 or more sessions per week) in the past 6 months, or if their diabetes is being managed with insulin. Individuals with recurrent hypoglycemic episodes, orthopedic, cardiovascular or respiratory conditions that would prevent participation in a progressive resistance training program will also be excluded from the study.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
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
Not yet recruiting
Date of first participant enrolment
Anticipated
13/04/2009
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] 4366 0
University
Name [1] 4366 0
University of South Australia
Country [1] 4366 0
Australia
Primary sponsor type
Individual
Name
Holly Evans
Address
School of Health Sciences,
University of South Australia
GPO Box 2471
Adelaide
SA 5001
Country
Australia
Secondary sponsor category [1] 3932 0
None
Name [1] 3932 0
Address [1] 3932 0
Country [1] 3932 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6415 0
University of South Australia's Human Research Ethics Committee
Ethics committee address [1] 6415 0
Executive Officer of this Committee:
Vicki Allen
University of South Australia
GPO Box 2471
Adelaide
SA 5001
Ethics committee country [1] 6415 0
Australia
Date submitted for ethics approval [1] 6415 0
01/12/2008
Approval date [1] 6415 0
Ethics approval number [1] 6415 0
P34908

Summary
Brief summary
The aim of this research is to determine the effect of a 16 week progressive resistance training program (12 week supervised program and a 4 week home-based program) on female adults with Type 2 diabetes. Specifically, this study will focus on the measures of lower limb proprioception and strength, blood glucose levels and adherence to these programs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35081 0
Address 35081 0
Country 35081 0
Phone 35081 0
Fax 35081 0
Email 35081 0
Contact person for public queries
Name 12428 0
Holly Evans
Address 12428 0
School of Health Sciences,
University of South Australia
GPO Box 2471
Adelaide
SA 5001
Country 12428 0
Australia
Phone 12428 0
+61 8 83022199
Fax 12428 0
Email 12428 0
[email protected]
Contact person for scientific queries
Name 3356 0
Holly Evans
Address 3356 0
School of Health Sciences,
University of South Australia
GPO Box 2471
Adelaide
SA 5001
Country 3356 0
Australia
Phone 3356 0
+61 8 83022199
Fax 3356 0
Email 3356 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.