Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000334505
Ethics application status
Approved
Date submitted
19/03/2015
Date registered
14/04/2015
Date last updated
31/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of repetitive cold water immersion on changes in physiological stress, perceived fatigue and physical performance during an eight week elite mixed martial arts training camp
Scientific title
Effect of repetitive cold water immersion on changes in physiological stress, perceived fatigue and physical performance during an eight week elite mixed martial arts training camp
Secondary ID [1] 286381 0
None
Universal Trial Number (UTN)
U1111-167-7256
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 294524 0
Muscle damage 294584 0
Oxidative stress 294585 0
Delayed onset muscle soreness 294693 0
Perceived fatigue 294694 0
Physical performance 294695 0
Condition category
Condition code
Inflammatory and Immune System 294830 294830 0 0
Other inflammatory or immune system disorders
Musculoskeletal 294833 294833 0 0
Normal musculoskeletal and cartilage development and function
Other 294988 294988 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
Cold water immersion - subjects will lie in a prone position in a temperature controlled 10 degree celsius bath up to the neck for 15 minutes. Inflammatory and muscle damage urinary biomarkers, along with questionnaires on perceived soreness, fatigue, physical performance and skin and core temperature will be collected and measured. During the eight week camp and final contest, subjects will immerse themselves in the bath immediately following training and the contest.
Intervention code [1] 291446 0
Prevention
Intervention code [2] 291447 0
Rehabilitation
Intervention code [3] 291489 0
Treatment: Other
Comparator / control treatment
The control treatment will be passive recovery. Subjects will sit at room temperature with the same variables collected for 15 minutes
Control group
Active

Outcomes
Primary outcome [1] 294595 0
Urinary neopterin by high performance liquid chromatography.
Timepoint [1] 294595 0
Neopterin will be measured before training commences every Tuesday, Thursday and Saturday during an eight week training camp, as well as before, immediately post, and at 1, 2, 24 and 48 hours post the contest
Primary outcome [2] 294636 0
Urinary total neopterin by high performance liquid chromatography
Timepoint [2] 294636 0
Total neopterin will be measured before training commences every Tuesday, Thursday and Saturday during an eight week training camp, as well as before, immediately post, and at 1, 2, 24 and 48 hours post the contest
Primary outcome [3] 294637 0
Urinary myoglobin by high performance liquid chromatography
Timepoint [3] 294637 0
Not measured during the training camp, but measured before, immediately post, and at 1, 2, 24 and 48 hours post the contest
Secondary outcome [1] 313689 0
Skin temperature will be assessed by thermistor
Timepoint [1] 313689 0
This will be measured at 0, 15, 1 and 2 hours post-contest only
Secondary outcome [2] 313778 0
Core temperature will be assessed by ingestible pill (CorTemp)
Timepoint [2] 313778 0
This will be measured at 0, 15, 1 and 2 hours post-contest only
Secondary outcome [3] 313779 0
Questionnaire about perceived soreness and discomfort. This is a visual analogue scale questionnaire replicated off the McGill short form pain questionnaire
Timepoint [3] 313779 0
Subjects will complete this at every sample collection time point (before training commences) during the training camp, as well as at 0, 15, 1 and 2 hours post the contest
Secondary outcome [4] 313974 0
Questionnaire about perceived feelings of fatigue/energy. This is a visual analogue scale questionnaire replicated off the McGill short form pain questionnaire
Timepoint [4] 313974 0
Subjects will complete this at every sample collection time point (before training commences) during the training camp
Secondary outcome [5] 313975 0
Coach performance analysis. The coaching staff of the subjects are former martial arts professionals. They will be asked to complete a visual analogue scale questionnaire (based on the McGill short form pain questionnaire) following each Tuesday, Thursday and Saturday training session evaluating the subjects performance.
Timepoint [5] 313975 0
Completed following the Tuesday, Thursday and Saturday training sessions during the eight week training camp
Secondary outcome [6] 313976 0
Physical performance - standing broad jump. Subjects will be asked to stand on a line and jump as far as possible and repeat three times. The best jump will be recorded
Timepoint [6] 313976 0
Subjects will complete this test at the beginning of every Tuesday, Thursday and Saturday training session during the eight week training camp
Secondary outcome [7] 313977 0
Physical performance - push-ups. Subjects will be asked to complete as many push-ups as possible (until failure) in one go.
Timepoint [7] 313977 0
Subjects will complete this test at the beginning of every Tuesday, Thursday and Saturday training session during the eight week training camp
Secondary outcome [8] 313978 0
Physical performance - pull-ups. Subjects will be required to complete as many over-hand pull-ups as possible in one go.
Timepoint [8] 313978 0
Subjects will complete this test at the beginning of every Tuesday, Thursday and Saturday training session during the eight week training camp

Eligibility
Key inclusion criteria
Elite mixed martial artists competing at provincial and national level
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Females that are pregnant, or anyone who has a disease that is tested often within the clubs

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Mixed martial arts clubs will be approached for their interest in participating in the study in Christchurch and Dunedin. Each individual who shows interest will then be provided with information pertaining to the research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using coin tossing to allocate the participants to one of the treatments. Allocation to one of the treatments will require subjects to complete their allocated protocol during the training camp and contest.
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
We will use general linear mixed modelling to test significance. In exercise testing of this nature, a minimum 10 subjects will be required to gauge the effectiveness of the intervention. We have specified 15 participants to gain as much statistical power as possible and to account for any drop-out during the study. If more subjects are interested then this will not prevent them from participating as well. The statistical assumptions for this include a significance of less than 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2015
Actual
9/04/2015
Date of last participant enrolment
Anticipated
Actual
26/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 6759 0
New Zealand
State/province [1] 6759 0
Canterbury and Otago

Funding & Sponsors
Funding source category [1] 290956 0
University
Name [1] 290956 0
University of Canterbury
Country [1] 290956 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Private Bag 4800
Christchurch 8140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 289638 0
None
Name [1] 289638 0
Address [1] 289638 0
Country [1] 289638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292554 0
Health and Disability Ethics Committee
Ethics committee address [1] 292554 0
Ethics committee country [1] 292554 0
New Zealand
Date submitted for ethics approval [1] 292554 0
11/03/2015
Approval date [1] 292554 0
26/03/2015
Ethics approval number [1] 292554 0
15/STH/41

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 388 388 0 0
/AnzctrAttachments/368210-Research Protocol FINAL.docx

Contacts
Principal investigator
Name 55898 0
A/Prof Steven Gieseg
Address 55898 0
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 55898 0
New Zealand
Phone 55898 0
+64 3 3642987 ext 7049
Fax 55898 0
Email 55898 0
[email protected]
Contact person for public queries
Name 55899 0
Steven Gieseg
Address 55899 0
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 55899 0
New Zealand
Phone 55899 0
+64 3 3642987 ext 7049
Fax 55899 0
Email 55899 0
[email protected]
Contact person for scientific queries
Name 55900 0
Steven Gieseg
Address 55900 0
University of Canterbury
Private Bag 4800
Christchurch 8140
Country 55900 0
New Zealand
Phone 55900 0
+64 3 3642987 ext 7049
Fax 55900 0
Email 55900 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.