Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001105336
Ethics application status
Approved
Date submitted
27/06/2017
Date registered
28/07/2017
Date last updated
30/05/2022
Date data sharing statement initially provided
30/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of endurance training on muscle adaptations in males.
Scientific title
The effects of exercise on markers of mitochondrial dynamics and mitochondrial remodelling in males.
Secondary ID [1] 292286 0
None
Universal Trial Number (UTN)
U1111-1198-3624
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic disorders 303805 0
Condition category
Condition code
Metabolic and Endocrine 303171 303171 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: low-intensity high-volume exercise.
Participants will train 3 to 4 times per week throughout the 8-week period. Each exercise session will consist of a continuous cycling bout at an intensity of 90% of the first lactate threshold (WLT1) on a stationary bike for a length of 60 to 150 min. Each training session will be performed at the Exercise Physiology laboratory at Footscray Park Campus (Victoria University). The intensity is selected for the exercise to be continuous without requiring high effort, and the duration of the bout is selected based on the usual session duration done by endurance athletes at low intensity and is progressively increased to a maximum of 150 min to stimulate training adaptations.

Group 2: high-intensity low-volume exercise.
Participants will train 3 to 4 times per week throughout the 8-week period. Each exercise session will consist of an interval session with 30-seconds all-out sprints at a maximum intensity on a stationary bike (load imposed in the bike corresponds to 0.075 kg/kg body mass, this is derived from the Wingate test), performing a total of 4 to 10 sprints. Rest interval between sprints will be 4 minutes at a very low intensity (50 W). Each training session will be performed at the Exercise Physiology laboratory at Footscray Park Campus (Victoria University). The intensity is based on previous literature performing 30-seconds all-out sprints, and the number of sprints performed in previous studies varies between 4 and 10, so to stimulate training adaptations the number of sprints performed in each session is progressively increased.

Both training groups are matched in the training load fold increase throughout the training period (e.g., both groups increase 2.5 times their weekly load from week 1 to week 8). Progression of the training is as follows: Week 1 (W1) will represent 100% of the training load; Week 2 training load will be the same as W1 + 25% of the load (in minutes for Group 1, and in sprints for Group 2); Week 3 will also be W1 + 50% of the load; this same pattern will be followed for Week 4 (W1 + 75 %), Week 6 (W1 + 100 %), Week 7 (W1 + 125 %), and Week 8 (W1 + 150 %). Only Week 5 will be different, as it will be like Week 3 (W1 + 50 %) to allow the training to follow a traditional periodised structure.

All training sessions will be supervised by an experienced sport scientist.
Intervention code [1] 298462 0
Lifestyle
Comparator / control treatment
Group 1 will act as a control group.
Control group
Active

Outcomes
Primary outcome [1] 302559 0
Mitochondrial content measured as mitochondrial volume are from electron microscopy (EM) images and citrate synthase activity from the enzyme activity assay. Both measurements are from skeletal muscle obtained from the vastus lateralis.
Timepoint [1] 302559 0
Before the first exercise session in week 1 and 72h after the last exercise session in week 8.
Primary outcome [2] 302560 0
Mitochondrial respiratory function in permeabilised fibres assessed with an oxygen respirometer that tracks changes in oxygen levels when substrates are added to the permeabilised fibres..
Timepoint [2] 302560 0
Before the first exercise session in week 1 and 72h after the last exercise session in week 8.
Primary outcome [3] 302894 0
Mitochondrial dynamics measured as protein content (via Western Blot technique) and gene expression (via quantitative polymerase chain reaction technique; qPCR) of MFN2, and OPA1 (mitochondrial fusion); protein content and gene expression of DRP1 and Mff (mitochondrial fission). All measurements are from skeletal muscle obtained from the vastus lateralis.This is a composite primary outcome.
Timepoint [3] 302894 0
Before and after the first exercise session in week 1.
Secondary outcome [1] 336372 0
Relationship between endurance performance adaptation (measured as time to complete 20 km) and mitochondrial content (as citrate synthase activity from the enzyme activity assay, and mitochondrial volume density from electron microscopy images from the skeletal muscle samples obtained from the vastus lateralis).
Timepoint [1] 336372 0
Before the first exercise session in week 1 and 72h after the last exercise session in week 8.
Secondary outcome [2] 337359 0
Mitochondrial specific degradation (mitophagy) measured as protein content (via Western Blot technique) and gene expression (via quantitative polymerase chain reaction technique; qPCR) of markers such as PINK1, phosphorylation of Ubiquitin at Serine 65, and Parkin. All measurements are from skeletal muscle obtained from the vastus lateralis. This is a composite secondary outcome.
Timepoint [2] 337359 0
Before and after the first exercise session in week 1.

Eligibility
Key inclusion criteria
Active participants (taking part in physical activity 1 to 3 times per week)
Free of injury
Free of any adverse health condition.
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any of the following:
1) sedentary
2) current muscle or ligament injury of the lower body.
3) current or previous cardiovascular or respiratory condition or abnormality.
4) current metabolic disease (e.g. diabetes)

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation based on the fitness level (measured as power output at the lactate threshold).
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
Results will be analysed using two-way repeated ANOVA where the within factor will be time and the between factor will be condition. Individual relationships between variables will be studied by means of linear regressions. The level of significance will be set at p<0.05 level. Assumptions of normality will be verified using the Shapiro-Wilk test before using parametric tests

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2017
Actual
18/09/2017
Date of last participant enrolment
Anticipated
31/03/2019
Actual
1/11/2018
Date of last data collection
Anticipated
30/06/2019
Actual
24/12/2018
Sample size
Target
28
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 16527 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 296827 0
University
Name [1] 296827 0
VICTORIA UNIVERSITY
Country [1] 296827 0
Australia
Primary sponsor type
University
Name
VICTORIA UNIVERSITY
Address
Institute of Sport, Exercise & Active Living
College of Sport and Exercise Science
Melbourne VIC 3011, Australia
Country
Australia
Secondary sponsor category [1] 295819 0
None
Name [1] 295819 0
Address [1] 295819 0
Country [1] 295819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298062 0
VICTORIA UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 298062 0
Ethics committee country [1] 298062 0
Australia
Date submitted for ethics approval [1] 298062 0
26/04/2017
Approval date [1] 298062 0
01/09/2017
Ethics approval number [1] 298062 0
HRE17-075

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

Contacts
Principal investigator
Name 75866 0
Prof David Bishop
Address 75866 0
Victoria University
Ballarat Rd
Footscray Park Campus
Footscray, Melbourne
3011, VIC
Australia
Country 75866 0
Australia
Phone 75866 0
+61 399199471
Fax 75866 0
Email 75866 0
[email protected]
Contact person for public queries
Name 75867 0
David Bishop
Address 75867 0
Victoria University
Ballarat Rd
Footscray Park Campus
Footscray, Melbourne
3011, VIC
Australia
Country 75867 0
Australia
Phone 75867 0
+61 399199471
Fax 75867 0
Email 75867 0
[email protected]
Contact person for scientific queries
Name 75868 0
Javier Botella Ruiz
Address 75868 0
Victoria University
Ballarat Rd
Footscray Park Campus
Footscray, Melbourne
3011, VIC
Australia
Country 75868 0
Australia
Phone 75868 0
+61 490534229
Fax 75868 0
Email 75868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any omics data generated will be shared (e.g., transcriptomics) upon request and deposited in online databases.
When will data be available (start and end dates)?
Once the article is published in a peer-reviewed journal the data will be available upon request. It is estimated to start in 2022, with no end date.
Available to whom?
Any researcher registered in a University or research center.
Available for what types of analyses?
For any omics analyses available.
How or where can data be obtained?
Via email to [email protected] or via the registered online databases where the data will be deposited.


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.