Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000073808
Ethics application status
Approved
Date submitted
12/01/2012
Date registered
16/01/2012
Date last updated
24/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Recovery from delayed-onset muscle soreness: traditional technique versus whole-body vibration
Scientific title
Recovery from delayed-onset muscle soreness: traditional technique versus whole-body vibration in healthy young adults who exercise regularly
Secondary ID [1] 279715 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed-onset muscle soreness (DOMS) 285552 0
Condition category
Condition code
Musculoskeletal 285744 285744 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete a 1 hour exercise bout designed to induce delay-onset muscle soreness where paricipants walk backwards on a 13 degree incline at a speed of 2.2km/h whilst wearing a 10kg weight belt. This will be supervised by an exercise scientist. Immediately following this exercise bout, participants will complete either 10 x 1 minute bouts of whole-body vibration, standing on a Galileo vibration plate set at 26Hz and 4.5mm amplitude, with a 30 second rest between bouts or 15 minutes of static strethcing. This is a randomised crossover study and following a seven day washout, participants will complete the 1 hour of backwards walking followed by the other preventative intervention.
Intervention code [1] 284013 0
Prevention
Intervention code [2] 284017 0
Treatment: Other
Comparator / control treatment
15 minutes of static stretching of all muscles in the lower body completed immediately following the same 1 hour exercise bout designed to induce delay-onset muscle soreness.
Control group
Active

Outcomes
Primary outcome [1] 286267 0
Walking pattern at self-selected speed and 1.3m/s, 1.6m/s and 2.0m/s using a GAITRite instrumented mat.
Timepoint [1] 286267 0
1, 2, 4 & 7 days post exercise
Primary outcome [2] 286268 0
leg power via a vertical jump on a force plate
Timepoint [2] 286268 0
1, 2, 4 & 7 days post exercise
Primary outcome [3] 286269 0
range of motion through ankle, knee and hip measured with a goniometer
Timepoint [3] 286269 0
1, 2, 4 & 7 days post exercise
Secondary outcome [1] 295471 0
over-ground running pattern using the 3D Vicon Motion Measurement System
Timepoint [1] 295471 0
2 & 7 days post exercise
Secondary outcome [2] 295472 0
muscle damage by measuring the blood marker creatine kinase
Timepoint [2] 295472 0
2 & 7 days post exercise

Eligibility
Key inclusion criteria
Exercise regularly (at least 3 times a week)
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Musculoskeletal condition that affects gait

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)
Participants will be screened according to American College of Sports Medicine criteria and have all joints assessed for level of functioning. Once they have met the inclusion criteria, participants will be randomly allocated to complete either the intervention or control conditions first using a computer generated list, concealed using individual opaque envelopes and administered by an independent researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequencing will be achieved through a computer generated list stratified for gender to ensure that equal numbers of males and females will complete the conditions in the same order.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
There will be a week 'wash-out' for each participant prior to completing the alternate condition.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/02/2012
Actual
19/03/2012
Date of last participant enrolment
Anticipated
Actual
24/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284497 0
Self funded/Unfunded
Name [1] 284497 0
Nil
Country [1] 284497 0
Primary sponsor type
Individual
Name
Dr Amanda Benson
Address
RMIT University
PO Box 71
Bundoora, Vic, 3083
Country
Australia
Secondary sponsor category [1] 283427 0
None
Name [1] 283427 0
Address [1] 283427 0
Country [1] 283427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286479 0
RMIT University Human Research Ethics Committee
Ethics committee address [1] 286479 0
Ethics committee country [1] 286479 0
Australia
Date submitted for ethics approval [1] 286479 0
Approval date [1] 286479 0
21/12/2011
Ethics approval number [1] 286479 0
63/11

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

Contacts
Principal investigator
Name 33622 0
Dr Amanda Benson
Address 33622 0
RMIT University, Bundoora Campus PO Box 71 Bundoora, Victoria, 3083
Country 33622 0
Australia
Phone 33622 0
+61399257677
Fax 33622 0
Email 33622 0
[email protected]
Contact person for public queries
Name 16869 0
Dr Amanda Benson
Address 16869 0
RMIT University, Bundoora Campus
PO Box 71
Bundoora, Victoria, 3083
Country 16869 0
Australia
Phone 16869 0
+61399257677
Fax 16869 0
Email 16869 0
[email protected]
Contact person for scientific queries
Name 7797 0
Assoc Prof Noel Lythgo
Address 7797 0
RMIT University, Bundoora Campus
PO Box 71
Bundoora, Victoria, 3083
Country 7797 0
Australia
Phone 7797 0
+61399256518
Fax 7797 0
Email 7797 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.