Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000580471
Ethics application status
Approved
Date submitted
22/03/2016
Date registered
4/05/2016
Date last updated
4/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of whole body vibration on the electromyographic activity of thigh muscles
Scientific title
The effects of whole body vibration on the electromyographic activity of thigh muscles in healthy male adults
Secondary ID [1] 288824 0
Nil known
Universal Trial Number (UTN)
U1111-1181-1495
Trial acronym
EWBVMC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Strength training 298099 0
Condition category
Condition code
Musculoskeletal 298267 298267 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants were randomised to receive each of the following interventions in a random order: control intervention, where participants performed squats in the platform, without vibration; squats with whole body vibration frequency of 25 Hz and squats with whole body vibration frequency of 50 Hz. The participants were invited to visit the facilities for 3 times and the cross-over trial had a wash out period of one week. The intervention was squatting with whole body vibration for 60 seconds, followed by 60 seconds of rest, with five repetitions. The exercises were supervised by physiotherapists trained in the method.
Intervention code [1] 294279 0
Rehabilitation
Comparator / control treatment
No secondary control group. The subjects will be their own control. The control intervention was squatting without whole body vibration for 60 seconds, followed by 60 seconds of rest, with five repetitions.
Control group
Active

Outcomes
Primary outcome [1] 297752 0
Electromyographic activity, expressed by the route mean square, of both quadriceps vastus, semimembranosus and semitendinosus muscles, bilaterally.
Timepoint [1] 297752 0
The electromyographic activity was assessed for 30 seconds before each exposure, for 60 seconds during each squatting and for 30 seconds after the exposure.
Secondary outcome [1] 322130 0
Perceived subjective effort, measured with the Borg Scale.
Timepoint [1] 322130 0
After each trial.

Eligibility
Key inclusion criteria
Healthy young adults
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
musculoskeletal surgeries, lesions or alterations of the spine and lower limbs, cardiovascular or metabolic diseases.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming alpha, 2-tailed, is set at .05, for an effect size of 0.65, and a priori analysis, for Anova repeated measures, within factors, we would need a sample of 8 participants, with 3 repetitions of measurements, to yield power of 95%.
Descriptive and Inferential analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
1/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
8
Recruitment outside Australia
Country [1] 7727 0
Portugal
State/province [1] 7727 0
Porto

Funding & Sponsors
Funding source category [1] 293184 0
University
Name [1] 293184 0
Universidade Fernando Pessoa
Country [1] 293184 0
Portugal
Primary sponsor type
University
Name
Universidade Fernando Pessoa
Address
UNIVERSIDADE FERNANDO PESSOA
Praca 9 de Abril, 349, 4249-004 Porto
Country
Portugal
Secondary sponsor category [1] 291975 0
None
Name [1] 291975 0
Address [1] 291975 0
Country [1] 291975 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294673 0
Universidade Fernando Pessoa Ethics Committee
Ethics committee address [1] 294673 0
Ethics committee country [1] 294673 0
Portugal
Date submitted for ethics approval [1] 294673 0
15/01/2014
Approval date [1] 294673 0
14/02/2014
Ethics approval number [1] 294673 0
14.02.2014

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

Contacts
Principal investigator
Name 64614 0
Dr Sandra Rodrigues
Address 64614 0
UNIVERSIDADE FERNANDO PESSOA
Praca 9 de Abril, 349, 4249-004 Porto
Country 64614 0
Portugal
Phone 64614 0
+351 22 5071300
Fax 64614 0
Email 64614 0
[email protected]
Contact person for public queries
Name 64615 0
Sandra Rodrigues
Address 64615 0
UNIVERSIDADE FERNANDO PESSOA
Praca 9 de Abril, 349, 4249-004 Porto
Country 64615 0
Portugal
Phone 64615 0
+351 22 5071300
Fax 64615 0
Email 64615 0
[email protected]
Contact person for scientific queries
Name 64616 0
Sandra Rodrigues
Address 64616 0
UNIVERSIDADE FERNANDO PESSOA
Praca 9 de Abril, 349, 4249-004 Porto
Country 64616 0
Portugal
Phone 64616 0
+351 22 5071300
Fax 64616 0
Email 64616 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.