Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000663550
Ethics application status
Approved
Date submitted
24/03/2015
Date registered
26/06/2015
Date last updated
21/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Neuromuscular, physiological and perceptual responses to linear vs. multidirectional high intensity running sessions in academy rugby union players.
Scientific title
Are measures of neuromuscular fatigue, as identified through dynamometry and sphygmomanometer scores, influenced when compared between two types of modified high intensity running sessions typically used in rugby training environments: i.e. linear (L) vs. shuttle run with multiple changes of direction (COD) in a group of Australian academy rugby union players.
Secondary ID [1] 286394 0
Nil Known
Universal Trial Number (UTN)
U1111-1168-5946
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromuscular fatigue 294557 0
physiological fatigue 294815 0
perceptual fatigue 294816 0
Condition category
Condition code
Other 294864 294864 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will run at maximal speed during 30 m shuttles set up in accordance to either protocol A or B. Each 30m of running will be followed by 30 m walking at <1 m/s.

Subjects will run a total distance of 1500 m in both protocols.

Prog A will involve participants running at maximal speeds for 30m in a straight line, followed by a 30m walk and repeated until 1500m of running has been complete. This will likely take 30-45 minutes to complete. This will only be ran once, with Prog B being tested 8 days later.

Prog B (8 days later) will involve participants running at maximal speeds for 30m in an outlined multidirectional manner. The 30m requested will involve periods of change of direction and/or acceleration/deceleration zones which will be outlined by cones and markers on the running field and will be guided by a running co-ordinator during the trial. Each 30m will again be followed by a 30m walk and will be repeated until 1500m running has been completed. This again will likely take 30-45 minutes to complete.

The personnel involved in supervising these sessions will be

A) the author - who will take neuromuscular measurements pre and post running. The author is a 6 year qualified and fully registered physiotherapist.

B) a strength and conditioner who will watch all running and direct the players whilst running as to various times for walking and direction to the next stations. This is a MSc level qualified strength and conditioner
Intervention code [1] 291471 0
Lifestyle
Comparator / control treatment
A repeated measures design will be used so that the same subjects will be used for each trial of the research. All participants will complete trial A then trial B 8 days later

While each participant will complete each running protocol (A) and (B), Prog B is more aligned to normal rugby training given it includes multidirectional running and/or acceleration/deceleration zones
Control group
Active

Outcomes
Primary outcome [1] 294615 0
Neuromuscular Fatigue as measured by handheld Dynamometry and a sphygmomanometer.
Timepoint [1] 294615 0
Post running of the trial - immediate assessment after running of the protocol & 48 hours post completion of the running trial.
Secondary outcome [1] 313721 0
Blood lactate concentration ([La]) scores from Prog A compared to Prog B. Will be measured by a Blood Lactate Machine post completion of the running protocol. This will not be measured pre running, as participants will be told to maintain same diet 24 hours prior to running - so blood lactate only measured after running.
Timepoint [1] 313721 0
Each outcome, aside from blood lactate will be measured pre running and post running
Blood lactate measured at 4 mins post completion of running of either of A or B
Secondary outcome [2] 314203 0
Heart rate (HR) will be measured by the GPS unit which will be fitted to the participant prior to any running has commenced. This will monitor throughout the whole testing and be recorded by the GPS co-ordinator.
Timepoint [2] 314203 0
HR pre running, during running, and upto 5 mins post running
Secondary outcome [3] 314204 0
Composite - Running speed, direction, acceleration zones and deceleration zones will all be measured using the GPS also which will be fitted to the participant prior to running and monitored throughout the whole testing day for prog A and prog B
Timepoint [3] 314204 0
GPS fitted pre assessment of running and taken off after completion of running
Secondary outcome [4] 314205 0
RPE - rate of perceived exertion will be measured pre/during & post both Prog A and prog B using the 6-20 BORG scale and will be asked at defined intervals
Timepoint [4] 314205 0
6-20 RPE at pre warm up, post warm up, 300m, 600m, 1200m, 1500m for both prog A and prog B and will be conducted by an assigned helper.
Secondary outcome [5] 314206 0
Session RPE - will be measured at no more than 15 minutes post completion of running protocol A or B. This will be the 1-10 cSession RPE scale which is a validated scale.
Timepoint [5] 314206 0
No greater than 15 minutes post completion of the running protocol A or B.
Secondary outcome [6] 314207 0
Neuromuscular measures will be taken both pre warm up and then taken again at the immediate completion of the running of either A or B.
3 measures will be taken with dynamometer (knee flexion, extension, eccentric hamstrings)

A) knee flexion as measured by dynamometer
Timepoint [6] 314207 0
pre warm up and then taken again at the immediate completion of the running of either A or B
Secondary outcome [7] 314208 0
knee extension as measured by dynamometer
Timepoint [7] 314208 0
Neuromuscular measures will be taken both pre warm up and then taken again at the immediate completion of the running of either A or B.
Secondary outcome [8] 314209 0
eccentric hamstrings as measured by dynamometer
Timepoint [8] 314209 0
Neuromuscular measures will be taken both pre warm up and then taken again at the immediate completion of the running of either A or B.
Secondary outcome [9] 314210 0
Adductor squeeze will also be taken as a measure of neuromuscular fatigue
Timepoint [9] 314210 0
Measured pre running and immediately upon completion of running protocol A or B

Eligibility
Key inclusion criteria
The player must be within the u20s academy squad for the 2015 season and must have had MSK clearance from the assessing physiotherapist prior to being invited for consideration of participation.

Participants must also have clearance from the club prior to being invited – (after MSK screening has been completed)
Minimum age
18 Years
Maximum age
20 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Failure of in-club musculoskeletal assessment

Club have the right to withdraw a participate also if required

Only players that would otherwise be involved in full contact/non-restricted/non-modified training sessions at the time which the study is being conducted will be selected as invitees for participation.

Any player not given permission by the club will also be excluded, despite them being eligible based on MSK assessment. The parent club will have ultimate say on inclusion of the player in the outlined study.

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)
Participants:

Approximately upto 25 male Australian academy rugby union players will be selected from the same rugby club academy. All players will be derived from the u20s squad of which the main author has access to.
As the target population of potential results are relevant towards a rugby population, the participants being used are relevant.


Recruitment Procedures:

All players are registered members of the academy at which the main author works (Super Rugby Club). Permission to invite members of the u20s to participate in this research has been granted by the club.

All registered academy players (upto30) will be addressed by the main researcher (lead academy physiotherapist) well in advance as to the research project proposal. At this stage, the academy players will receive a short presentation by the lead researcher then be given the prepared ‘subject information sheet’ which will outline all aspects of the project described.

Subjects will then be asked to volunteer for the project prior to a defined date if they feel they would like to take part. The initial phase of subject recruitment will be that of identifying willing subjects and commence MSK screening.

Subjects will therefore be required to volunteer and then consent (via informed consent form) to phase 1 of subject recruitment (MSK screen for research purposes only).

From those consenting volunteers, a MSK screen will be completed by the lead researcher. After MSK screening is complete, those players who then still meet the inclusion criteria will be invited to formally participate in the research and further written information regarding the research will be issued along with additional informed consent forms.

Data will then be destroyed for those then not meeting the inclusion criteria at this stage.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No allocation to groups.

all participants will complete protocol A and then protocol B 8 days later

For timing of run, ie time of day, at a pre-organised familiarisation day, numbers will be drawn from a hat to determine the timing of each participants trial. This time will then be maintained for both running of trial A and of trial B.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Participants:

Approximately ~25 male Australian academy rugby union players will be selected from the same rugby club academy. All players will be derived from the u20s squad of which the main author has access to.
As the target population of potential results are relevant towards a rugby population, the participants being used are relevant.


Sampling:

Given there are 30 registered players within the rugby union academy in which the main author works, this number will constitute the initial sought after sample size.
The group in question is of particular interest towards this research piece (aims/objectives) and thus has been selected based on the purpose of the study and the knowledge of this population. The sampling technique to be used is therefore that of a ‘purposive’ method. Given the nature of the study, this population is already working/training within the academy environment and are thus deemed to likely already meet the eligibility characteristics to be able to perform the desired tasks within the data collection stages.
The research design (crossover, repeated measures) means that there is less chance of natural variation between individuals being responsible for the skewing of any results (due to all participants completing all aspects of the testing in the design) and as a result this method design requires fewer participants. The aim therefore is that ~25 participants will be eligible after the exclusion criteria is performed and potential other confounding variables are accounted for.


Retention Strategies:

The main researcher will send text messages 48 and 24 hours prior to scheduled time of arrival for all participants. For those who do not have a phone, a contact number will need to be provided for the duration of the study. This aims to remind participants to attend as scheduled.


Setting:

The setting will be that of the normal academy training location for the u20s group as discussed. All data will be collected at the address: IKON Park, Royal Parade, Carlton, Melbourne, VIC, Australia. This address will also be used for all the pre-assessment MSK screening and trial days before participants complete Protocols A and B (Data Collection).
A maintained grass rugby pitch, used throughout the year by the u20s squad, will be used for all running protocols. Environmental conditions including temperature, humidity & wind direction will be recorded prior to the commencement of any running.
An area will be marked on the pitch where all assessments will take place (Registration/GPS, Neuromuscular Assessment, Lactate Measurement, Rate of Perceived Exertion). An area will also be marked where the warm up will take place prior to the running trials. The required shuttle distances will also be marked on the floor across the grass field area.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis:

Data/statistical analysis will be completed on the generated data using software tools such as SPSS (v.15, SPSS (copyright) Inc., Chicago, IL, USA), Microsoft (copyright) Excel (Office 2014) and GPS manufacturer software (Sprint 5.0, Catapult (copyright) novations, Australia).


participant number: 25 has been selected as a target number for participation. 32 players make the playing group which will be targeted.
no statistical power calculations have been performed.


Statistical Analysis:

All data is to be assessed with both Microsoft Excel and SPSS so that data can be expressed in terms of standard deviation (SD) and means. The normality distribution of the data will be examined using an appropriate statistical test (Shapiro-Wilk) and homogeneity of variance will be verified using again an appropriate test (Levene test).

After confirming normal distribution, a paired t-test will likely be used to analyse the pre & post neuromuscular assessment findings along with heart rate and rate of perceived exertion responses.

A one-way analysis of variance (ANOVA) with repeated measures will then be used (likely) to compare all values obtained in the 2 running protocols (A) and (B) upon completion of (B).
In addition an order of testing will also be assessed for, aiding the statistical analysis and discussion.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2015
Actual
27/11/2015
Date of last participant enrolment
Anticipated
8/01/2016
Actual
19/02/2016
Date of last data collection
Anticipated
19/02/2016
Actual
19/02/2016
Sample size
Target
25
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290970 0
Self funded/Unfunded
Name [1] 290970 0
Liam James Robinson
Country [1] 290970 0
Australia
Primary sponsor type
University
Name
University of Bath, United Kingdom
Address
Alan Buckingham - Research Lead
Department for Health
University of Bath
Claverton Down
Bath
BA2 7AY
United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 289650 0
Individual
Name [1] 289650 0
Aaron Coutts (Project Supervisor)
Professor in Sport and Exercise Science
Address [1] 289650 0
Sport and Exercise Discipline Group
Faculty of Health
University of Technology, Sydney
Eton Rd,
Lindfield,
NSW,
2070 (PO Box 222)
Australia
Country [1] 289650 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292564 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 292564 0
Ethics committee country [1] 292564 0
Australia
Date submitted for ethics approval [1] 292564 0
29/05/2015
Approval date [1] 292564 0
04/08/2015
Ethics approval number [1] 292564 0
EC00146
Ethics committee name [2] 292565 0
University of Bath Research Ethics Approval Committee for Health (REACH)
Ethics committee address [2] 292565 0
Ethics committee country [2] 292565 0
United Kingdom
Date submitted for ethics approval [2] 292565 0
01/04/2015
Approval date [2] 292565 0
22/05/2015
Ethics approval number [2] 292565 0
REACH approval EP 13 / 14 254

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 360 360 0 0
/AnzctrAttachments/368223-RPD-Final_Proposal_LiamJRobinson_Appendix.docx
Attachments [2] 362 362 0 0
/AnzctrAttachments/368223-RPD_FinalProposal_FEEDBAD_PASS_LiamJRobinson_KS.docx
Attachments [3] 405 405 0 0
/AnzctrAttachments/368223-PRF_Final_Application_SeedingGrant_2015_Liam_James_Robinson.docx
Attachments [4] 406 406 0 0
/AnzctrAttachments/368223-Annex_One_LIAM_ROBINSON_FINAL.docx
Attachments [5] 407 407 0 0
/AnzctrAttachments/368223-Annex_Three_LIAM_ROBINSON_FINAL.docx
Attachments [6] 408 408 0 0
/AnzctrAttachments/368223-Annex_Four_LIAM_ROBINSON_FINAL.docx

Contacts
Principal investigator
Name 55950 0
Mr Liam James Robinson
Address 55950 0
Clinic -
Melbourne Sports Physiotherapy
934 Mount Alexander Road,
Essendon,
VIC,
3040,
Australia.

Club -
Melbourne Rebels Rugby Union Football Club
IKON Park Gate 3,
Level 2,
Royal Parade,
Carlton North
VIC
3054
Australia
Country 55950 0
Australia
Phone 55950 0
61413034270
Fax 55950 0
Email 55950 0
[email protected]
Contact person for public queries
Name 55951 0
Liam James Robinson
Address 55951 0
Clinic -
Melbourne Sports Physiotherapy
934 Mount Alexander Road,
Essendon,
VIC,
3040,
Australia.


Club -
Melbourne Rebels Rugby Union Football Club
IKON Park Gate 3,
Level 2,
Royal Parade,
Carlton North
VIC
3054
Australia
Country 55951 0
Australia
Phone 55951 0
61413034270
Fax 55951 0
Email 55951 0
[email protected]
Contact person for scientific queries
Name 55952 0
Liam James Robinson
Address 55952 0
Clinic -
Melbourne Sports Physiotherapy
934 Mount Alexander Road,
Essendon,
VIC,
3040,
Australia.


Club -
Melbourne Rebels Rugby Union Football Club
IKON Park Gate 3,
Level 2,
Royal Parade,
Carlton North
VIC
3054
Australia
Country 55952 0
Australia
Phone 55952 0
61413034270
Fax 55952 0
Email 55952 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.