Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000531213
Ethics application status
Approved
Date submitted
22/12/2017
Date registered
10/04/2018
Date last updated
25/07/2019
Date data sharing statement initially provided
8/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of 3 vibration types on pelvic floor muscles activity
Scientific title
The effect of experimentally selected whole-body vibration, stochastic resonance whole-body vibration and localized vibration parameters on bioelectric activity of pelvic floor muscles in continent women - a randomized controlled study.
Secondary ID [1] 293633 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic floor muscle activity 305970 0
Condition category
Condition code
Renal and Urogenital 305163 305163 0 0
Other renal and urogenital disorders
Musculoskeletal 305164 305164 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 305165 305165 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will be randomly allocated to one of three groups based on computer random number generator.
Each group will consist of 15 participants. The groups will be homogeneous with respect to age, body weight, height, maximum voluntary pelvic floor muscle contraction (sEMG MVC) and pelvic floor muscle strength (Oxford grading scale score).
Methods
The study protocol has been approved by the Bioethics Committee.
The measurements will be performed under standard testing conditions, the same for all subjects.
The bioelectric potential of the muscles (sEMG) will be measured with surface electrodes, and, in the case of pelvic floor muscles, with vaginal probes. Each study participant will be equipped with a personal probe. The probe will be inserted using a small amount of antiallergic lubricant with the sensors positioned laterally in the vagina. Co-activation of the synergistic muscles during voluntary contraction of pelvic floor muscles will also be investigated.
Muscle activity will be recorded from the following muscle groups: pelvic floor muscles and synergistic muscles (the rectus abdominis, the gluteus maximus, the transversus abdominis/ internal abdominal oblique muscle, the medial gastrocnemius muscle)
All subjects will be instructed on the correct contraction of pelvic floor muscles and will be able to observe sEMG signals on the computer monitor during the instruction session. All sEMG recordings will be performed by the same investigator.
The MVC procedures (three 5-second attempts at maximum contraction with a 60 second rest in between):
- to recruit pelvic floor muscles in A and B groups - standing position (= testing position, static standing with feet hip-width apart; hip and knee flexion 35°) and in supine lying position (the hip and knee will be positioned at 30° and 90° of flexion, respectively). In group C - MVC will be measured in the testing position (patient’s forearms supported with Redcord slings).
- to recruit the rectus abdominis:
feet flat secured to the table with a strap; supported sitting in a 30-degree position; the subject’s shoulder girdle strapped to the table; a sit-up attempt.
- to recruit the transversus abdominis:
supine lying with abdominal hollowing exercises
- to recruit the gluteus maximus:
prone lying, pelvic girdle strapped to the table, overextension in the hip joint, lower leg secured to the table with the knee in full extension
- to recruit the medial gastrocnemius:
bench-sitting with resistance against the restrained hip with the knee extended and unilateral plantar flexion at 90° ankle position. A rigid seat belt strap will be placed around the sole of the foot.

The aims of the Phase 0 of the study are:
1. Intra- and intersession reliability of sEMG recording during:
a/maximum voluntary pelvic floor muscle (PFM) contraction in standing (= testing position) and in supine-lying position
b/resting PFM activity in standing (60 seconds)
c/60 seconds of synchronous whole-body vibration (Fitvibe 600) of two intensities,
d/60 seconds of stochastic resonance whole-body vibration (SRT Zeptor® Medical-plus noise) of two vibration intensities,
e/60 seconds of localized vibration, ie., controlled vibration to selected body parts (Redcord Stimula) of two intensities
2.Correlations among synchronous whole-body vibration, stochastic resonance whole-body vibration and localized vibration
Phase 0 will consist of:
a/ the measurement of the maximal voluntary contraction (MVC) of the investigated muscles (random order)
b/ sEMG recording of resting PFM activity in supine lying (60 seconds x 3 trials, in groups A, B and C)
c/ sEMG recording of resting PFM activity in standing (60 seconds x 3 trials). Testing position in group A and B: static standing with feet hip-width apart; hip and knee flexion 35°. Testing position in group C: static standing with the participant's forearms supported with Redcord slings.
d/ 3 x 60s sEMG recordings during synchronous whole-body vibration with vibration intensity of 30 Hz/2mm and 3 x 60s of 40 Hz/4 mm (group A) (random order).
e/ 3 x 60s sEMG recordings during stochastic resonance whole-body vibration of basic frequency 6 Hz/ noise level 2; and 3 x 60s of 12 Hz/ noise level 4 (group B) (random order).
f/ 3 x 60s sEMG recordings during vibration applied through the ropes with vibration intensity of 30Hz/ medium amplitude – trim 3 and 50Hz/ high amplitude – trim 5 (group C) (random order).
Prior to Phase 0, all subjects will be instructed on the correct contraction of the pelvic floor muscles and will be able to observe sEMG signals on the computer monitor during the instruction session.
The study procedure (MVC, resting activity in supine and standing positions, 3 x 60s sEMG recordings during vibration) will be repeated after one-hour rest (with vaginal electrode and surface electrodes in place) in order to assess inter-trial reliability.
It will also be repeated during the follicular phase of the next menstrual cycle of each study participant to assess inter-day reliability.

The aims of the phase 1 of the study are:
1. to compare the effect of different intensity synchronous whole-body vibration (Fitvibe 600), stochastic resonance whole-body vibration (SRT Zeptor® Medical-plus noise) and localized vibration, ie., controlled vibration to selected body parts (Redcord Stimula) on reflex activity of pelvic floor muscles
2. to determine the effect of the above vibration methods on the sEMG amplitude of voluntary pelvic floor muscle contractions.

Phase 1 will consist of:
Stage 1 - control phase in group A - synchronous whole-body vibration (WBV)
Testing position: static standing with feet hip-width apart; hip and knee flexion 35 degree
a/ sEMG recording of MVC PFM in standing (= testing position)
b/ sEMG recording of resting PFM activity in standing (10 seconds)
c/ sEMG recording of two quick-flick contractions and two 10s-contractions in standing
d/ sEMG recording – vibration switched off – standing position (60 seconds)
e/ sEMG recording – immediately after the 60second non-vibration standing – two quick-flick contractions, two 10 second contractions, 10 second relaxation period
Stage 2 - intervention phase
Testing position: static standing on the vibration platform with feet hip-width apart; hip and knee flexion 35 degree
60 second sEMG recordings during synchronous whole-body vibration of 6 different vibration intensities (random order): 20 Hz/2mm, 20 Hz/ 4 mm,
30 Hz/ 2mm, 30 Hz/ 4 mm,
40 Hz/ 2 mm and 40 Hz/ 4 mm,
Stage 3
sEMG recording immediately after each of the 60s vibration intensities. After stepping off the platform, resting PFM activity as well as PFM activity during two quick-flick contractions and two 10 second contractions will be recorded (standing position).
All measurements will be performed on the same day.

Stage 1 - control phase in group B - stochastic resonance whole-body vibration (ST):
Testing position: static standing with feet hip-width apart – each foot on one of the plates; hip and knee flexion 35 degree
a/ sEMG recording of MVC PFM in standing (=testing position)
b/ sEMG recording of resting PFM activity in standing (10 seconds)
b/ sEMG recording of resting PFM activity in standing (10 seconds)
c/ sEMG recording of two quick-flick contractions and two 10 second contractions in standing
d/ sEMG recording – vibration switched off – standing position (60 seconds)
e/ sEMG recording – immediately after the 60 second non-vibration standing – two quick-flick contractions, two 10s contractions, 10s relaxation period
Stage 2 - intervention phase
Testing position: static standing with feet hip-width apart – each foot on one of the plates; hip and knee flexion 35 degree
60s sEMG recordings during stochastic resonance whole-body vibration of 6 different vibration intensities (random order):
Basic frequency: 6 Hz/ noise level 2; 6 Hz/ noise level 4; 10 Hz/ noise level 2; 10 Hz/ noise level 4; 12 Hz / noise level 2; 12 Hz/ noise level 4.

Stage 3
sEMG recording immediately after each of the 60s stochastic resonance vibration intensities. After stepping off the platform, resting PFM activity as well as PFM activity during two quick-flick contractions and two 10s-contractions will be recorded (standing position).
All measurements will be performed on the same day.

Stage 1 - control phase in group C – vibration applied through the ropes of the Redcord Stimula
Testing position: static standing with the participant's forearms supported with Redcord slings
a/ sEMG recording of MVC PFM in testing position
b/ sEMG recording of resting PFM activity in testing position (10 seconds) - the participant's forearms supported with Redcord slings
c/ sEMG recording of two quick-flick contractions, two 10 second contractions
d/ sEMG recording – vibration switched off; testing position (60 seconds)
e/ sEMG recording – immediately after the 60 second non-vibration recording – two quick-flick contractions, two 10 second contractions, 10 second relaxation period
Stage 2 – intervention phase
60s sEMG recordings during Redcord Stimuli vibration of 6 different intensities (random order): 30Hz / trim 3; 30Hz/ trim 5
40 Hz/ trim 3; 40Hz/ trim 5
50 Hz/ trim 3; 50Hz/ trim 5
Stage 3
sEMG recording immediately after each of the 60 second Redcord Stimuli vibration intensities. After stepping off the platform, resting PFM activity as well as PFM activity during two quick-flick contractions and two 10s-contractions will be recorded.
Each vibration will last 60 seconds with a 10-minute break between subsequent applications. All measurements will be performed on the same day.
Intervention code [1] 299936 0
Prevention
Intervention code [2] 299937 0
Rehabilitation
Comparator / control treatment
None of the groups is strictly the control group. There is the control measurement performed in each of the groups during Stage 1 (ie., the control phase)...

Control phase - participants will assume the respective testing position but no vibrations will be applied. In group A the testing position will be static standing with feet hip-width apart; hip and knee flexion 35°. In group B: static standing with feet hip-width apart – each foot on one of the plates; hip and knee flexion 35°
In group C: static standing with the participant's forearms supported with Redcord slings.

All participants will undergo a single application of each of 6 different vibration intensities (acute effects). Each vibration will last 60s with a 10-minute break between subsequent applications. All measurements will be performed on the same day...
The mode of administration will be one-on-one face-to-face.
The target intensity will be the reference value of MVC (maximal voluntary contraction) for voluntary contractions and reflex activity of the pelvic floor muscles and synergistic muscles..
Control group
Active

Outcomes
Primary outcome [1] 304314 0
This is a composite primary outcome.
Change in pelvic floor sEMG activity during voluntary contraction prior and after vibrations of different intensity.
Measured parameters: mean amplitude (% MVC), peak amplitude (%MVC) and variability of the signal (the variability of data around the mean value of the selected period of the analysis, expressed as %MVC)
Timepoint [1] 304314 0
Change in pelvic floor activity during voluntary contraction will be recorded prior to and after vibrations of different intensity.
Primary outcome [2] 304315 0
This is a composite primary outcome.
Change in pelvic floor sEMG activity during vibrations (reflex activation) of different intensity. Measured parameters: mean amplitude (% MVC), peak amplitude (%MVC) and variability of the signal (the variability of data around the mean value of the selected period of the analysis, expressed as %MVC)
Timepoint [2] 304315 0
Surface electromyography (sEMG) of pelvic floor activity will be recorded during 60- second vibrations of different intensity.
Secondary outcome [1] 341569 0
Change in activity of the rectus abdominis assessed by means of surface electromyography (sEMG) during voluntary contraction of pelvic floor muscles.
.
Timepoint [1] 341569 0
Change in activity of the rectus abdominis assessed during voluntary contraction of pelvic floor muscles.
Secondary outcome [2] 344620 0
Change in activity of the gluteus maximus assessed by means of surface electromyography (sEMG) during voluntary contraction of pelvic floor muscles
Timepoint [2] 344620 0
Change in activity of the gluteus maximus assessed during voluntary contraction of pelvic floor muscles.
Secondary outcome [3] 344621 0
Change in activity of the transversus abdominis/ internal abdominal oblique muscle assessed by means of surface electromyography (sEMG) during voluntary contraction of pelvic floor muscles
Timepoint [3] 344621 0
Change in activity of the transversus abdominis/ internal abdominal oblique muscle assessed during voluntary contraction of pelvic floor muscles.

Eligibility
Key inclusion criteria
a. nulliparous women
b. no history of previous vibration platform exercises
c. good general health
d. no contraindications to vibration training
Minimum age
19 Years
Maximum age
30 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a history of disequilibrium,
acute inflammatory conditions and infections,
epilepsy,
cardiovascular diseases,
acute osteoarthritis,
stress urinary incontinence,
pregnancy,
childbirth(s),
menstruation,
a history of pelvic surgery,
diabetes,
hypertension,
neurological abnormalities,
urinary tract infection,
elevated temperature,
spinal pain,
pelvic organ prolapse > Io in POP-Q
postvoid residual urine volume > 150ml
unhealed fracture
nephrolithiasis.

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)
Initial recruitment will be based on inclusion criteria and performed by a person not involved in the investigations. Candidates who will meet the criteria will be randomly allocated to three groups. Allocation will be concealed by simple randomisation using a central randomisation by computer .

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistics
Sample size:
We will assume the probability of a type I error a = 0.05, target power of 1-beta = 0.80 and a 25% minimum significant difference between the means of parameters studied. The resultant minimum sample size will be 15 participants. The target sample size will 45 participants; 4 additional participants will be recruited to account for dropouts (for example due to artifact EMG signals). The study participants will be randomly assigned to 3 groups (Group A – 15; Group B – 15, and Group C – 15).
The Shapiro–Wilk and Lilliefors tests will be used to check whether the data have a normal distribution while variance homogeneity will be investigated with the Levene’s test.

If the data meets the assumption of normality and variance homogeneity, the variables will be compared with ANOVA for repeated measures. The post-hoc comparisons will be performed using the Bonferroni test.

If the data will not follow a normal distribution and variance homogeneity, statistical significance will be assessed using nonparametric tests.
The Kruskal-Wallis test (ANOVA on ranks) will be used to determine if there are statistically significant differences between the variables determined for each group and measurements.The mean-ranks post-hoc test will be used for multiple pairwise comparison.
Intra-group comparisons will be done using Friedman’s ANOVA by ranks and multiple comparisons with an appropriate post-hoc test.
If nonparametric tests are employed, the measures of central tendency and dispersion will be the median and the lower and upper quartile.
Data skewness, kurtosis and modality will also be checked. Given that the distribution of results in a randomly selected sample will be unimodal and skewness and kurtosis (flatness) lower than 2.5, the arithmetic mean and standard deviation will be selected as the most appropriate to assess central value and dispersion.
The associations between qualitative variables will be determined using the chi-square test.
In all tests the level of statistical significance will be set at p = 0.05. The data analysis tool is Statistica, version 12.
The reliability will be assessed by the intraclass correlation coefficient (ICC).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/08/2019
Actual
Date of last participant enrolment
Anticipated
1/11/2019
Actual
Date of last data collection
Anticipated
1/11/2019
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 9462 0
Poland
State/province [1] 9462 0
Silesia

Funding & Sponsors
Funding source category [1] 298250 0
University
Name [1] 298250 0
The Jerzy Kukuczka Academy of Physical Education
Country [1] 298250 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education
Address
72a Mikolowska Street
40-065 Katowice
Country
Poland
Secondary sponsor category [1] 297365 0
None
Name [1] 297365 0
None
Address [1] 297365 0
None
Country [1] 297365 0
Other collaborator category [1] 279875 0
University
Name [1] 279875 0
Faculty and Department of Basic Biomedical Sciences of the Medical University of Silesia in Katowice
Address [1] 279875 0
Kasztanowa 3 Street
41-200 Sosnowiec
Country [1] 279875 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299256 0
The Research Ethics Committee from the Jerzy Kukuczka Academy of Physical Education in Katowice
Ethics committee address [1] 299256 0
Ethics committee country [1] 299256 0
Poland
Date submitted for ethics approval [1] 299256 0
24/11/2017
Approval date [1] 299256 0
05/12/2017
Ethics approval number [1] 299256 0
1/2017

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

Contacts
Principal investigator
Name 79810 0
Mrs Daria Chmielewska
Address 79810 0
Faculty of Physiotherapy, Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland
Country 79810 0
Poland
Phone 79810 0
+48691951906
Fax 79810 0
Email 79810 0
d.chmielewska@awf.katowice.pl
Contact person for public queries
Name 79811 0
Magdalena Stania
Address 79811 0
Faculty of Physiotherapy, Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland
Country 79811 0
Poland
Phone 79811 0
+48694979640
Fax 79811 0
Email 79811 0
m.stania@awf.katowice.pl
Contact person for scientific queries
Name 79812 0
Daria Chmielewska
Address 79812 0
Faculty of Physiotherapy, Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland
Country 79812 0
Poland
Phone 79812 0
+48691951906
Fax 79812 0
Email 79812 0
d.chmielewska@awf.katowice.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices)
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access the data.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1795Ethical approval    374188-(Uploaded-05-04-2019-00-52-58)-Study-related document.pdf



Results publications and other study-related documents

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