Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001026819
Ethics application status
Approved
Date submitted
11/06/2021
Date registered
5/08/2021
Date last updated
5/08/2021
Date data sharing statement initially provided
5/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Resistance training for type 2 diabetes
Scientific title
Investigating the effects of eccentric versus concentric whole-body resistance training on insulin sensitivity and glucose control in patients with type 2 diabetes
Secondary ID [1] 293656 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 305943 0
Condition category
Condition code
Metabolic and Endocrine 305137 305137 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effects of eccentric resistance training on insulin sensitivity, blood lipid profile, glucose control, physical fitness, strength, cognition and quality of life in adults with Type 2 Diabetes. The exercise intervention will be divided into 2 groups, eccentric resistance training and concentric resistance training. Participants will participate in eccentric resistance training exercises twice a week (1 hour sessions each) for a period of 12 weeks with assessments/tests conducted at the start (baseline/week 0), mid (week 6 post training) and end of the intervention (week 12 post training). 8 different exercises (chest press, lateral pulldown, bicep curl, leg extension, leg curl, calf raise, abdominal crunch) will be performed using resistance training machines supervised by an accredited exercise physiologist at the Vario Exercise Clinic, Edith Cowan University Joondalup. The mode of administration is one-on-one at a level of progressive intensity commencing at low intensity (10% 1RM) increasing up to high intensity (100% 1RM). Participants will not be asked to perform additional exercise at home. Session adherence will be monitored via Excel spreadsheet attendance checklist.
Intervention code [1] 299916 0
Rehabilitation
Intervention code [2] 321027 0
Treatment: Other
Comparator / control treatment
Concentric Resistance Training Group.
The ECC group is commencing at 10%. The effects and outcomes measured in the eccentric resistance training group will be compared with a controlled concentric resistance training group. Participants will perform concentric resistance training exercises twice a week (1 hour sessions each) for a period of 12 weeks with assessments/tests conducted at the start (baseline/week 0), mid (week 6 post training) and end of the intervention (week 12 post training). 8 different exercises (chest press, lateral pulldown, bicep curl, leg extension, leg curl, calf raise, abdominal crunch) will be performed using resistance training machines supervised by an accredited exercise physiologist at the Vario Exercise Clinic, Edith Cowan University Joondalup. The mode of administration is one-on-one at a level of progressive intensity commencing at moderate intensity (50% 1RM) increasing up to high intensity (100% 1RM). Participants will not be asked to perform additional exercise at home. Session adherence will be monitored via Excel spreadsheet attendance checklist.
Control group
Active

Outcomes
Primary outcome [1] 304294 0
Blood diabetes markers - Plasma glucose, serum insulin, HbA1c
As previously mentioned, this is a composite primary outcome
Timepoint [1] 304294 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Primary outcome [2] 328106 0
Blood lipid profile - Total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides
Timepoint [2] 328106 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [1] 341517 0
This is a composite secondary outcome
Physical fitness - 6minute walk test, sit-to-stand test, timed up-and-go test, balance
Timepoint [1] 341517 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [2] 396746 0
Muscle strength for chest press as measured by one-repetition maximal strength (1RM)
Timepoint [2] 396746 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [3] 396747 0
Body composition to assess fat mass, lean mass, body fat % measured via DXA
Timepoint [3] 396747 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [4] 398466 0
Muscle strength for lateral pulldown press as measured by one-repetition maximal strength (1RM)
Timepoint [4] 398466 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [5] 398467 0
Muscle strength for bicep curl press as measured by one-repetition maximal strength (1RM)
Timepoint [5] 398467 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [6] 398468 0
Muscle strength for triceps extension press as measured by one-repetition maximal strength (1RM)
Timepoint [6] 398468 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [7] 398469 0
Muscle strength for leg extension press as measured by one-repetition maximal strength (1RM)
Timepoint [7] 398469 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [8] 398470 0
Muscle strength for leg curl press as measured by one-repetition maximal strength (1RM)
Timepoint [8] 398470 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [9] 398471 0
Muscle strength for calf raise press as measured by one-repetition maximal strength (1RM)
Timepoint [9] 398471 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)
Secondary outcome [10] 398472 0
Muscle strength for abdominal crunch press as measured by one-repetition maximal strength (1RM)
Timepoint [10] 398472 0
Pre-intervention (baseline/week 0), Mid-intervention (week 6), Post-intervention (week 12)

Eligibility
Key inclusion criteria
(i) age 50 – 80 years
(ii) diagnosis of Type 2 diabetes
(iii) presenting with no co-morbidities or contraindications to exercise
(iv) no resistance training for at least 3 months prior to the participation in the present study
(v) medical clearance for participation
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-diabetic or pre-disposed to type 2 diabetes
Participation in resistance/strength training in the last 3 months

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 envelope
Methods used to generate the sequence in which subjects will be randomised (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
Statistical methods / analysis
All statistical analyses were performed using the IBM SPSS v27.0 statistical package (SPSS Inc., Chicago, IL, USA). Data analyses included standard descriptive statistics, t-tests, ANOVA and correlation tests. Data was assessed by a Shapiro-Wilk test for normality and a Levene test for the homogeneity of variance assumption. Baseline values of each variable were compared between ECC and CON groups by an independent samples t-test. Changes over time for the outcome measures from baseline to post-intervention were compared between the groups by a repeated measures mixed-design two-way ANOVA, and their changes were compared between groups by independent t-test. In the case of a significant interaction (group x time) effect, a Tukey’s post-hoc test was performed to identify and compare the differences between groups for each time point. Effect sizes (ES) was calculated using Cohen’s d represented as ES = (MeanPost - MeanPre) / SDPre and was considered as small (d > .2), medium (d > .5), and large effect (d > 0.8). All statistical results are shown in mean ± standard deviation (SD) unless otherwise stated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/02/2018
Date of last participant enrolment
Anticipated
Actual
4/06/2018
Date of last data collection
Anticipated
Actual
31/10/2018
Sample size
Target
22
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 34371 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 298273 0
University
Name [1] 298273 0
Edith Cowan University
Country [1] 298273 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive, Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 297392 0
None
Name [1] 297392 0
Address [1] 297392 0
Country [1] 297392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299275 0
Human Research Ethic Committee Edith Cowan University
Ethics committee address [1] 299275 0
Ethics committee country [1] 299275 0
Australia
Date submitted for ethics approval [1] 299275 0
19/10/2017
Approval date [1] 299275 0
27/11/2017
Ethics approval number [1] 299275 0
19307

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

Contacts
Principal investigator
Name 79878 0
Miss Christine Kudiarasu
Address 79878 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive, Joondalup WA 6027
Country 79878 0
Australia
Phone 79878 0
+61863046089
Fax 79878 0
Email 79878 0
[email protected]
Contact person for public queries
Name 79879 0
Christine Kudiarasu
Address 79879 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive, Joondalup WA 6027
Country 79879 0
Australia
Phone 79879 0
+61863046089
Fax 79879 0
Email 79879 0
[email protected]
Contact person for scientific queries
Name 79880 0
Christine Kudiarasu
Address 79880 0
Exercise Medicine Research Institute
Edith Cowan University
270 Joondalup Drive, Joondalup WA 6027
Country 79880 0
Australia
Phone 79880 0
+61863046089
Fax 79880 0
Email 79880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy and confidentiality - only summary results will be published in a journal article


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12030Ethical approval    374205-(Uploaded-30-06-2021-12-50-47)-Study-related document.pdf



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.