Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000366358
Ethics application status
Approved
Date submitted
27/02/2017
Date registered
10/03/2017
Date last updated
10/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of post-exercise water immersion on muscular performance in athletes.
Scientific title
The effect of post-exercise water immersion on muscular performance in athletes.
Secondary ID [1] 291285 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscular Performance 302238 0
Muscular Adaptation 302239 0
Inflammation 302240 0
Condition category
Condition code
Inflammatory and Immune System 301835 301835 0 0
Other inflammatory or immune system disorders
Physical Medicine / Rehabilitation 301868 301868 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A session will consist of performing resistance training exercise followed by a water immersion or control condition. Exercise sessions will involve a combination of weightlifting (snatch OR clean and jerk, and associated derivatives) and traditional unilateral/bilateral resistance training exercises e.g. [vertical counter-movement jump; barbell front squat; barbell Romanian deadlift; single-leg Bulgarian squats; single-leg Romanian deadlift; single-leg knee extension and single-leg leg curl (for hypertrophic responses only). These exercises will be performed for 3-5 sets until (technical) failure, with a variety of loads ranging from of 1-12 repetitions maximum (RM)].

Each session will differ in the post-exercise water immersion condition only and will be performed at the same time of day for each participant. The post-exercise water immersion conditions will be either CWI (15 mins at 15 degrees Celsius), HWI (15 mins at 40 degrees Celsius), NWI (15 mins at 34.5 degrees Celsius), beginning 30 mins post-exercise. Immersion will be passive seated, up to a depth of shoulder height.

All sessions (exercise and treatment conditions) will be supervised and withdrawn if participants do not perform repetitions in accordance with test protocols.

A wash-out period of minimum 5 days will be used.
Intervention code [1] 297304 0
Treatment: Other
Comparator / control treatment
There will also be a fourth passive seated (15 mins passive seated at room temperature of 20-25 degrees Celsius) condition to act as a control (CON).
Control group
Active

Outcomes
Primary outcome [1] 301257 0
Lower limb maximum voluntary contraction will be assessed using an isometric test i.e. isometric mid-thigh pull (IMTP).

Force-time curve data will be collected using a dual force plate (Kislter MARS, Kislter Instrument AG, Winterthur, Switzerland). On arrival at the laboratory for muscular performance testing, participants will complete a standardised warm-up consisting of 5 mins cycling (70W resistance) on a cycle ergometer (Wattbike Trainer - Giant 2015 Model, Nottingham, UK) followed by 5 mins of dynamic stretches focusing on muscle groups that will be used during testing. This will be followed by the execution of 3 sub-maximal repetitions of the test using a technique that corresponds with each participant’s individual set-up position for that exercise as identified during the familiarisation session.

Participants will be instructed to complete two 'fast and forceful' maximal IMTP repetitions for 5 s, with a 2 mins rest between repetitions as per the test protocols described by Haff et al. (2013). Reliability of the rate of force development for the IMTP will be optimised by analysing the force-time curve using pre-determined bands such as 0–30, 0–50, 0–90, 0–100, 0–150, 0–200, and 0–250 milliseconds given these time zones have previously been demonstrated to provide the highest reliability (ICCalpha: 0.70, and CV: <15%) by Haff et al. (2013). Participants will repeat the above testing again post-exercise at 0/2/24/48 h time-points. All performance testing will occur in the presence of pre-scripted verbal encouragement. Participants will not receive feedback until completion of the study in order to avoid influencing future test trials. All sessions will be supervised and withdrawn if participants do not perform repetitions in accordance with test protocols.
Timepoint [1] 301257 0
Participants will perform the above testing pre-exercise, and post-exercise at 0/2/24/48 h time-points.
Primary outcome [2] 301382 0
Lower limb maximum voluntary contraction will be assessed using a dynamic tests i.e. squat jump (SJ).

Force-time curve data will be collected using a dual force plate (Kislter MARS, Kislter Instrument AG, Winterthur, Switzerland). On arrival at the laboratory for muscular performance testing, participants will complete a standardised warm-up consisting of 5 mins cycling (70W resistance) on a cycle ergometer (Wattbike Trainer - Giant 2015 Model, Nottingham, UK) followed by 5 mins of dynamic stretches focusing on muscle groups that will be used during testing. This will be followed by the execution of 3 sub-maximal repetitions of the test using a technique that corresponds with each participant’s individual set-up position for that exercise as identified during the familiarisation session.

SJ testing will be performed in accordance with protocols as described by Sheppard et al. (2011). A linear position transducer (Fitness Technology, Adelaide, Australia) will be attached to the dowel. Jumps will be analysed for peak force, peak velocity and jump height.

Participants will repeat the above testing again post-exercise at 0/2/24/48 h time-points. All performance testing will occur in the presence of pre-scripted verbal encouragement. Participants will not receive feedback until completion of the study in order to avoid influencing future test trials. All sessions will be supervised and withdrawn if participants do not perform repetitions in accordance with test protocols.
Timepoint [2] 301382 0
Participants will perform the above testing pre-exercise, and post-exercise at 0/2/24/48 h time-points.
Primary outcome [3] 301383 0
Lower limb maximum voluntary contraction will be assessed using a dynamic tests i.e. counter-movement jump (CMJ).

Force-time curve data will be collected using a dual force plate (Kislter MARS, Kislter Instrument AG, Winterthur, Switzerland). On arrival at the laboratory for muscular performance testing, participants will complete a standardised warm-up consisting of 5 mins cycling (70W resistance) on a cycle ergometer (Wattbike Trainer - Giant 2015 Model, Nottingham, UK) followed by 5 mins of dynamic stretches focusing on muscle groups that will be used during testing. This will be followed by the execution of 3 sub-maximal repetitions of the test using a technique that corresponds with each participant’s individual set-up position for that exercise as identified during the familiarisation session.

CMJ testing will be performed in accordance with protocols as described by Sheppard et al. (2011). A linear position transducer (Fitness Technology, Adelaide, Australia) will be attached to the dowel. Jumps will be analysed for peak force, peak velocity and jump height.

Participants will repeat the above testing again post-exercise at 0/2/24/48 h time-points. All performance testing will occur in the presence of pre-scripted verbal encouragement. Participants will not receive feedback until completion of the study in order to avoid influencing future test trials. All sessions will be supervised and withdrawn if participants do not perform repetitions in accordance with test protocols.
Timepoint [3] 301383 0
Participants will perform the above testing pre-exercise, and post-exercise at 0/2/24/48 h time-points.
Secondary outcome [1] 332114 0
Blood samples will be collected to assess the time-course of systemic blood-based bio-markers of muscle damage (IL-6, Creatine kinase and Heat Shock Protein 70) in response to the exercise and intervention.

At each collection time-point, a 4.0mL ethylenediaminetetraacetic acid (EDTA), 8.0mL serum and 8.0mL lithium heparin tube will be collected in order to permit analysis of a complete set of blood serum chemistry and inflammatory cytokines. Blood samples will be collected by a trained phlebotomist from a superficial forearm vein using standardised venepuncture techniques into BD Vacutainer tubes (BD Diagnostics, New Jersey, USA). Upon collection, samples will be allowed sit for 20 mins at room temperature to facilitate coagulation. The sample tubes will then be centrifuged (Centrifuge CF 20-R, Awel SAS, Blain, France) for 10 mins at 4000 rpm at a temperature of 4 degrees Celsius to separate plasma. The obtained plasma sample will then be aliquoted into multiple 1.0mL Externally Threaded CryoFreeze (Scientific Specialities Inc., California, USA) cryogenic storage tubes which will be placed in a cryogenic CryoFreeze Storage Rack (Scientific Specialities Inc., California, USA) for preservation at -80 degrees Celsius.
Timepoint [1] 332114 0
Participants will be requested to provide blood samples pre-exercise, and post-exercise at 0/2/24/48 h time-points.

Eligibility
Key inclusion criteria
Elite and sub-elite athletes with a minimum 12 months resistance training experience with acknowledged use and proficiency in the weightlifting derivatives will be sought as volunteers for the studies. Athletes will be recruited on the basis that they have been involved in a whole-body resistance training program (greater than or equal to 2/week) for the last 12 months.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria will be participants that do not have a minimum 12 months resistance training experience with acknowledged use and proficiency in the weightlifting derivatives. Individual participants who have pre-existing injuries will also be excluded.

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 phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be performed using the R Project for Statistical Computing (www.r-project.org). Data will be assessed against a normal distribution as per the Shapiro–Wilk test. Descriptive statistics will be utilised as appropriate. A 4x5 repeated-measures ANOVA will be used to evaluate time, treatment condition and treatment condition x time interaction effects (The R Project for Statistical Computing, http://www.r-project.org/). Following ANOVA, multiple pairwise comparisons will be evaluated by a paired t-test and validated using the false discovery rate (Curran-Everett, 2000). Absolute data will be used to analyse changes between pre- versus post-treatment adaptive responses, whereas relative changes (% or fold change) from pre- to post-intervention will be used to analyse markers of muscle damage markers along with other subjective measures. Differences between conditions will be expressed with 95% confidence limits and standardised (Hedge’s g) effect sizes. Magnitudes of effect sizes will be assessed as follows: 0.2 to 0.5 for a 'small effect', 0.51 to <0.8 for a 'moderate effect', and > or equal to 0.8 for a 'large effect'. Student–Newman–Keuls post hoc tests will be used to determine the significance of pair-wise comparisons of changes with time and differences between sessions. Data will be presented as mean +/- SD. Significance will be accepted at P < 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/02/2017
Date of last participant enrolment
Anticipated
31/05/2017
Actual
Date of last data collection
Anticipated
31/12/2017
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 295749 0
Government body
Name [1] 295749 0
Australian Institute of Sport
Country [1] 295749 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Dr,
Joondalup,
Perth
WA 6027
Country
Australia
Secondary sponsor category [1] 294593 0
None
Name [1] 294593 0
Address [1] 294593 0
Country [1] 294593 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297050 0
ECU Ethics Committee
Ethics committee address [1] 297050 0
Ethics committee country [1] 297050 0
Australia
Date submitted for ethics approval [1] 297050 0
04/11/2016
Approval date [1] 297050 0
02/12/2016
Ethics approval number [1] 297050 0
10142052

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

Contacts
Principal investigator
Name 72810 0
Mr Barry Horgan
Address 72810 0
Australian Institute of Sport,
Department of Physiology,
1 Leverrier St,
Bruce,
ACT 2617
Country 72810 0
Australia
Phone 72810 0
(+61)479161212
Fax 72810 0
Email 72810 0
[email protected]
Contact person for public queries
Name 72811 0
Barry Horgan
Address 72811 0
Australian Institute of Sport,
Department of Physiology,
1 Leverrier St,
Bruce,
ACT 2617
Country 72811 0
Australia
Phone 72811 0
(+61)479161212
Fax 72811 0
Email 72811 0
[email protected]
Contact person for scientific queries
Name 72812 0
Greg Haff
Address 72812 0
ECU,
270 Joondalup Drive,
Joondalup,
Perth,
WA 6027
Country 72812 0
Australia
Phone 72812 0
(+61)863045416
Fax 72812 0
Email 72812 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.