Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000468921
Ethics application status
Approved
Date submitted
4/05/2011
Date registered
5/05/2011
Date last updated
3/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Compression Stockings and Recovery in marathon runners.
Scientific title
A study into 18-65 year old marathon runners and the recovery benefits of compression socks following marathon racing quantified by fatigue levels, muscle soreness, and recovery measured in a timed, Heart rate monitored graduated treadmill run to exhaustion compared to sham stockings.
Secondary ID [1] 260109 0
Nil
Universal Trial Number (UTN)
U1111-1121-1574
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
muscle recovery 265785 0
Condition category
Condition code
Musculoskeletal 265939 265939 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Commercially available Jobst Compression socks giving lower limb compression with a pressure at ankle of 30-40mmHg. Worn continuously for 48 hours starting within 1 hour of completing the marathon.
Intervention code [1] 264525 0
Treatment: Other
Comparator / control treatment
non-compressive Stiva socks giving no lower limb compression with a pressure at ankle of 0-1mmHg. Worn continuously for 48 hours starting within 1 hour of completing the Melbourne marathon.
Control group
Placebo

Outcomes
Primary outcome [1] 266690 0
muscle soreness measured using a visual analog scale between 1-10
Timepoint [1] 266690 0
7 days post event
Primary outcome [2] 266691 0
perceived fatigue measured using a visual analog scale between 1-10
Timepoint [2] 266691 0
7 days post event
Primary outcome [3] 266692 0
Graduated Treadmill run to exhaustion
Timepoint [3] 266692 0
14 days pre and post event
Secondary outcome [1] 276204 0
Graded treadmill run to exhaustion. Protocol involves a 5min warmup at 4km/hr and 2% gradient. Treadmill is then progressively increased in speed by 2km/hr every 2 mins until exhaustion. They will have access to 1x700ml bottle of comercially available gatorade sports drink throughout the run. Exertion will be measured using a polar heart rate monitor and average and maximum heart rate throughout the test will be recorded.
Timepoint [1] 276204 0
14 days pre and post marathon
Secondary outcome [2] 276205 0
Time Trial to exhaustion perceived exertion. This will be measured using the visual analog Borg's Rating of perceived Exertion scale every 2 minutes into each treadmill stage.
Timepoint [2] 276205 0
14 days pre and post marathon

Eligibility
Key inclusion criteria
Marathon Participants
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
peripheral vascular disease

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)
Participants voluntarily enrolled through marathon newsletters. Participants blinded randomised by use of computer random number sequence generation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number sequence generation created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/08/2011
Actual
1/07/2012
Date of last participant enrolment
Anticipated
1/11/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265013 0
Self funded/Unfunded
Name [1] 265013 0
Stuart Armstrong
Country [1] 265013 0
New Zealand
Primary sponsor type
Individual
Name
Stuart Armstrong
Address
38C Windmill Rd
RD3
Tamahere
Waikato
3283
Country
New Zealand
Secondary sponsor category [1] 264107 0
None
Name [1] 264107 0
Address [1] 264107 0
Country [1] 264107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266986 0
Monash University
Ethics committee address [1] 266986 0
Monash University
Building 3E Room 111
Clayton Campus
Wellington Rd
Clayton
Vic 3800
Ethics committee country [1] 266986 0
Australia
Date submitted for ethics approval [1] 266986 0
01/06/2011
Approval date [1] 266986 0
21/03/2012
Ethics approval number [1] 266986 0

Summary
Brief summary
My study is to investigate the possible benefit of lower limb compression stockings on recovery following an endurance running event. I will ask the participants to perform a 10km running time trial on a treadmill with heart rate and perceived exertion monitoring. This will be done 2 weeks before and 2 weeks after the Melbourne marathon. The participants will be given either compression tights with a high compressive value or tights with no compression to wear for 48 hours after the marathon. They will be asked to record muscle soreness and fatigue levels in the 7 days following the marathon.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32569 0
Dr Stuart Armstrong
Address 32569 0
38C Windmill Rd
RD3
Tamahere
3283
Country 32569 0
New Zealand
Phone 32569 0
+64 211 492 438
Fax 32569 0
Email 32569 0
[email protected]
Contact person for public queries
Name 15816 0
Dr Dr Stuart Armstrong
Address 15816 0
38C Windmill Rd
RD3
Tamahere
Waikato
3283
Country 15816 0
New Zealand
Phone 15816 0
+64 211 492 438
Fax 15816 0
Email 15816 0
[email protected]
Contact person for scientific queries
Name 6744 0
Dr Dr Stuart Armstrong
Address 6744 0
38C Windmill Rd
RD3
Tamahere
Waikato
3283
Country 6744 0
New Zealand
Phone 6744 0
+64 211 492 438
Fax 6744 0
Email 6744 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
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