Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000427875
Ethics application status
Not yet submitted
Date submitted
13/04/2012
Date registered
16/04/2012
Date last updated
16/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of cold water immersion for recovery of soldiers in the operational environment.
Scientific title
Effectiveness of cold water immersion vs passive recovery for enhancing recovery as measured by pain, power and fatigue, of combat soldiers in an operational environment.
Secondary ID [1] 280318 0
Nil
Universal Trial Number (UTN)
U1111-1129-9282
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recovery from intense physical exertion 286280 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286507 286507 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being studied is cold water immersion. Subjects will be immersed up to and including their shoulders in cold water for 14 minutes at 15 degrees celsius, as soon as practicable after returning from combat operations. Each subject will undergo the CWI intervention twice and the passive recovery intervention twice in a crossover fashion. The minimum period between interventions will be 4 days.
Intervention code [1] 284672 0
Prevention
Comparator / control treatment
The control intervention is passive recovery, which will involve the subjects sitting quietly for 14 minutes as soon as practicable after returning from combat operations.
Control group
Active

Outcomes
Primary outcome [1] 286940 0
Pain measured on a numerical rating scale (0-10). Subjects will be asked to rate the worst pain that they currently have.
Timepoint [1] 286940 0
Primary outcomes will be measured on four occasions per intervention:
Baseline (within 24hrs prior to the operational mission)
After the mission before intervention
The morning after intervention
The second morning after intervention
Primary outcome [2] 286941 0
Power measured by vertical leap, utilising a VERTEC vertical leap assessment tower.
Timepoint [2] 286941 0
Primary outcomes will be measured on four occasions per intervention:
Baseline (within 24hrs prior to the operational mission)
After the mission before intervention
The morning after intervention
The second morning after intervention
Primary outcome [3] 286942 0
Physical fatigue measured on a numerical rating scale (0-10). Subjects will be asked to rate their current level of overall physical fatigue.
Timepoint [3] 286942 0
Primary outcomes will be measured on four occasions per intervention:
Baseline (within 24hrs prior to the operational mission)
After the mission before intervention
The morning after intervention
The second morning after intervention
Secondary outcome [1] 297035 0
Flexibility measured via a sit and reach test.
Timepoint [1] 297035 0
Flexibility will be measured on four occasions per intervention:
Baseline (within 24hrs prior to the operational mission)
After the mission before intervention
The morning after intervention
The second morning after intervention

Eligibility
Key inclusion criteria
Members who are currently deployed on operations in Afghanistan and who are involved in combat operations on foot.
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
A past history of arrhythmias
A past history of cold hypersensitivity
A current injury preventing members from participating in a vertical leap assessment
Open wounds or skin infection

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will be recruited from the deployed task group.
Subjects will be allocated a subject number in the order that they sign up to the trial.

An intervention group allocation schedule will be created by an offsite investigator using computer generated random numbers. This schedule will be concealed from the on-site investigators until after the subjects have been allocated their subject numbers. The schedule will then be provided to one on-site assistant who will advise the subjects of their intervention group. This assistant will not be involved in the collection of outcome measures.
The subjects will be advised not to disclose which intervention they were involved in with the investigator taking outcome measures on each occasion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur via computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Repeated measures - each participant will undergo CWI and passive recovery two times each.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4256 0
Afghanistan
State/province [1] 4256 0
Uruzgan

Funding & Sponsors
Funding source category [1] 285084 0
Self funded/Unfunded
Name [1] 285084 0
Country [1] 285084 0
Primary sponsor type
Individual
Name
Angela Rogers
Address
Physiotherapy Dept
Campbell Barracks
Swanbourne WA 6010
Country
Australia
Secondary sponsor category [1] 283950 0
University
Name [1] 283950 0
Curtin University
Address [1] 283950 0
School of Physiotherapy
Building 408, Level 3
Curtin University
Kent St
Bentley WA 6102
Country [1] 283950 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287100 0
Ethics committee address [1] 287100 0
Ethics committee country [1] 287100 0
Date submitted for ethics approval [1] 287100 0
13/04/2012
Approval date [1] 287100 0
Ethics approval number [1] 287100 0

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

Contacts
Principal investigator
Name 34059 0
Address 34059 0
Country 34059 0
Phone 34059 0
Fax 34059 0
Email 34059 0
Contact person for public queries
Name 17306 0
Angela Rogers
Address 17306 0
Physiotherapy Dept
Campbell Barracks
Swanbourne WA 6010
Country 17306 0
Australia
Phone 17306 0
+61 08 9269 8820
Fax 17306 0
+61 08 9269 8758
Email 17306 0
[email protected]
Contact person for scientific queries
Name 8234 0
Angela Rogers
Address 8234 0
Physiotherapy Dept
Campbell Barracks
Swanbourne WA 6010
Country 8234 0
Australia
Phone 8234 0
+61 08 9269 8820
Fax 8234 0
+61 08 9269 8758
Email 8234 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.