Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000728235
Ethics application status
Approved
Date submitted
20/08/2009
Date registered
24/08/2009
Date last updated
24/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the autonomic response to whole body vibration in young healthy subjects.
Scientific title
Effect of whole body vibration in young healthy subjects on autonomic response assessed through heart variability
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autonomic response following exposeure to whole body vibration 243566 0
excessive orthosympathetic activation induced by whole body vibration which could be potentially harmful in selected patients 243571 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239861 239861 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Whole body vibration (WBV) through stimulation of mechanoceptors and muscle spindle endings elicits tonic vibration reflex, thus producing muscular contraction at lower limbs. Subjects were asked to maintain orthostatic position with a knee flexion of 60° on the vibration board. The experimental protocol consisted in 3 sessions of WBV lasting two minute each at frequency of 30, 45 and 55 Hz with 3mm peak to peak amplitude respectively. Each vibrating session was followed by a one minute pause to enable muscular recovery. Electrocardiografic registrations (ECG) were recorded at five different timepoints: 5 minutes before the first WBV session (PRE), during each of the three WBV session at different frequencies and 1 minute after the end of the last WBV session (POST).
Intervention code [1] 241167 0
Treatment: Devices
Intervention code [2] 241173 0
Rehabilitation
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240645 0
Variations in Heart Rate Variability (HRV)components. Data were processed with an analogic/digital converter (micro 1401 CED Cambridge Electronic Design, Cambridge, UK), recorded on a PC by means of a data acquisition system (Spike2 v.5, CED) with a sampling rate of 3000 Hz. Guidelines (Task force, 1996) were followed for time recordings, sampling rate and HRV analysis of electrocardiograms. Artifacts and noise regions were removed and in case of premature beats they have been manually corrected. Only recordings that contained <1% of premature beats were considered.
ECGs have been analysed by means of a software called "HRV analysis", which can perform a wide range of measurements of HRV in time and frequency domain, including mean HR measurements
Timepoint [1] 240645 0
Baseline, during each 2 minute vibration period, and 1 minute after the end of vibration.
Secondary outcome [1] 257279 0
Heart rate, directly derived from ECG
Timepoint [1] 257279 0
Baseline, during each 2 minute vibration period, and 1 minute after the end of vibration.
Secondary outcome [2] 257287 0
respiratory rate obtained through a stretch sensitive device positioned at the chest level to measure chest expansion that occurred during each respiratory act.
Timepoint [2] 257287 0
Baseline, during each 2 minute vibration period, and 1 minute after the end of vibration.

Eligibility
Key inclusion criteria
Healthy subjects
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cardiovascular diseases such as hypertension, heart failure or cardiac arrhythmia.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 1960 0
Italy
State/province [1] 1960 0

Funding & Sponsors
Funding source category [1] 237530 0
Government body
Name [1] 237530 0
Research Agency of the Piedmont Region
Country [1] 237530 0
Italy
Primary sponsor type
Government body
Name
Research Agency of the Piedmont Region
Address
Corso Stati Uniti, 1 – 10128 Torino
Country
Italy
Secondary sponsor category [1] 237004 0
None
Name [1] 237004 0
Address [1] 237004 0
Country [1] 237004 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 30079 0
Address 30079 0
Country 30079 0
Phone 30079 0
Fax 30079 0
Email 30079 0
Contact person for public queries
Name 13326 0
Marco Invernizzi
Address 13326 0
v.le Piazza d'Armi n°1
28100 Novara
Country 13326 0
Italy
Phone 13326 0
+3903213734844
Fax 13326 0
Email 13326 0
[email protected]
Contact person for scientific queries
Name 4254 0
Marco Invernizzi
Address 4254 0
v.le Piazza d'Armi n°1
28100 Novara
Country 4254 0
Italy
Phone 4254 0
+3903213734844
Fax 4254 0
Email 4254 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.