Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000720819
Ethics application status
Approved
Date submitted
5/02/2021
Date registered
9/06/2021
Date last updated
9/06/2021
Date data sharing statement initially provided
9/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Resistance exercise and immune health
Scientific title
Investigation of the effect of eight weeks whole body high intensity resistance exercise training on immune measures in healthy males.
Secondary ID [1] 303366 0
None
Universal Trial Number (UTN)
U1111-1264-9047
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical performance 320629 0
immunity 321010 0
Condition category
Condition code
Musculoskeletal 318484 318484 0 0
Normal musculoskeletal and cartilage development and function
Inflammatory and Immune System 318815 318815 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eight-week High intensity training (HIT)
All participants will be required to complete an eight-week HIT programme consisting of two HIT training sessions (45 minutes approximately) a week with at least 72 hours recovery between sessions.
Prior to starting each session, participants are required to complete a 5 minute warm-up cycle on a cycle ergometer set at an intensity of 70 watts.
Participants will then be asked to complete a full body high intensity weight circuit, training with maximal intensity on each given exercise, with a rest of 60-90 seconds between each exercise. Maximal intensity is assessed in each exercise by reaching momentary muscular failure, whereby another repetition becomes impossible for the participant.
The exercises will be carried out in the following order :
1. Squat:
2. Leg extension:
3. Leg curl:
4. Standing calf raise:
5. Pull down
6. Bench press:
7. Seated row:
8. Shoulder press:
9. Bicep curl:
10. Tricep extension:

The exercise training sessions will be overseen by Dr Andrew Carroll, a researcher with more than 10 years experience. Exercise sessions will be in person 2x per week at Massey University, Palmerston North.
Intervention code [1] 319676 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326442 0
Skeletal muscle strength: Isometric strength measures (knee flexion & extension), estimated 1 rep max testing for each of the 10 prescribed resistance exercises and isometric mid-thigh pull.
Timepoint [1] 326442 0
Pre/post 8 weeks intervention
Primary outcome [2] 326443 0
Cell phenotype of circulating granulocytes, monocytes and lymphocytes, specifically neutrophils, inflammatory macrophages, T cells and NK cells will be assessed as a composite primary outcome by flow cytometry.
Timepoint [2] 326443 0
Pre/post 8 weeks intervention
Primary outcome [3] 326444 0
This is a composite primary outcome. All participants will be asked to provide venous blood samples before and after the 8 week intervention, and the T cells will be isolated from the blood samples. These T cells will then be stimulated with phorbol myristate acetate (PMA) and the resulting cytokine production (IL-4, IL-2, CXCL10 (IP-10), IL-1ß, TNFa, CCL2 (MCP-1), IL-17A, IL-6, IL-10, IFN-gamma, IL-12p70, CXCL8 (IL-8), TGF-ß1) will be measured in the cell culture media by multiplex bead assay.
Timepoint [3] 326444 0
Pre/post 8 weeks intervention
Secondary outcome [1] 391503 0
Saliva Cortisol levels
Timepoint [1] 391503 0
Pre/post 8 weeks intervention
Secondary outcome [2] 391504 0
Plasma myokine concentrations (IL-6, IL-15, TGF-ß1, IL-4, IL-8, IL-7, Irisin, apelin, FABP-3, FGF-21, MGF, IGF-1). Cytokine levels are to be assesed as a secondary composite by multiplex bead assay and Elisa.
Timepoint [2] 391504 0
Pre/post 8 weeks intervention
Secondary outcome [3] 391505 0
Profile of Mood States (POMS) Questionnaire
Timepoint [3] 391505 0
Pre/post 8 weeks intervention
Secondary outcome [4] 391506 0
Resting heart rate will be measured using a digital Polar Heart Rate monitor.
Timepoint [4] 391506 0
Pre/post 8 weeks intervention
Secondary outcome [5] 391507 0
Body composition: body weight (measured by analogue scales), body fat %, muscle distribution, muscle mass, bone mineral content (using the InBody bio-impedance machine), and Limb circumference (measured using tape measure) are to be combined as a secondary composite measure.
Timepoint [5] 391507 0
Pre/post 8 weeks intervention
Secondary outcome [6] 392714 0
Blood pressure will be analysed using a digital sphygmometer.
Timepoint [6] 392714 0
Pre/post 8 weeks intervention

Eligibility
Key inclusion criteria
Healthy individuals (male) 18-40 years, who are not following any specialised diets and not currently undertaking regular resistance exercise. Participants will be required to complete a health questionnaire and provide written consent for this study.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are unwilling or unable to provide informed written consent or comply with study procedures. All participants will be in good physical health and. Participants will also be excluded if they have (i) blood borne diseases (e.g., hepatitis), (ii) clinically diagnosed high/low blood pressure, (iii) recent bacterial or viral illness, (iv) are taking any mediation that affects the properties of blood (e.g. blood clotting) (iv) any recent musculoskeletal injuries within the past 3 months).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Power analysis from a previous exercise study was used to calculate the number of volunteers appropriate for this study (Minitab Version 18.1). Our analysis reveal that 3 participants is sufficient to detect a difference in strength between time points with a power of 80% (p = 0.05). To account for the possibility of participant withdrawal, we will enrol 8 participants to this study. Additionally, as previous HIIT studies assessing immune markers have used a similar number of participants, this number should also be suitable for secondary outcome measures (Alizadeh H, Safarzade A. High intensity intermittent training induces anti-inflammatory cytokine responses and improves body composition in overweight adolescent boys. Horm Mol Biol Clin Investig. 2019 Aug 1;39(3):/j/hmbci.2019.39.issue-3/hmbci-2019-0004/hmbci-2019-0004.xml. doi: 10.1515/hmbci-2019-0004. PMID: 31369392.).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
16/04/2021
Date of last participant enrolment
Anticipated
Actual
23/04/2021
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
8
Accrual to date
Final
7
Recruitment outside Australia
Country [1] 23435 0
New Zealand
State/province [1] 23435 0
Manawatu

Funding & Sponsors
Funding source category [1] 307780 0
Government body
Name [1] 307780 0
Plant & Food Research
Country [1] 307780 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jocelyn Eason
Address
Plant & Food Research,
Batchelar Road,
Palmerston North,
4442
Country
New Zealand
Secondary sponsor category [1] 308487 0
None
Name [1] 308487 0
Address [1] 308487 0
Country [1] 308487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307799 0
Central HDEC
Ethics committee address [1] 307799 0
Ethics committee country [1] 307799 0
New Zealand
Date submitted for ethics approval [1] 307799 0
05/02/2021
Approval date [1] 307799 0
25/03/2021
Ethics approval number [1] 307799 0
21/STH/44

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

Contacts
Principal investigator
Name 108538 0
Dr Andrew Carroll
Address 108538 0
Plant & Food Research,
Batchelar Road,
Palmerston North
4442
Country 108538 0
New Zealand
Phone 108538 0
+642102660637
Fax 108538 0
Email 108538 0
[email protected]
Contact person for public queries
Name 108539 0
Andrew Carroll
Address 108539 0
Plant & Food Research,
Batchelar Road,
Palmerston North
4442
Country 108539 0
New Zealand
Phone 108539 0
+642102660637
Fax 108539 0
Email 108539 0
[email protected]
Contact person for scientific queries
Name 108540 0
Andrew Carroll
Address 108540 0
Plant & Food Research,
Batchelar Road,
Palmerston North
4442
Country 108540 0
New Zealand
Phone 108540 0
+642102660637
Fax 108540 0
Email 108540 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
No - IPD will not be available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10453Study protocol  [email protected] 381370-(Uploaded-05-02-2021-14-24-11)-Study-related document.docx



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.