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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pelvic floor muscle activity

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Prevention

Intervention code [2]

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]

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]

Change in pelvic floor activity during voluntary contraction will be recorded prior to and after vibrations of different intensity.

Primary outcome [2]

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]

Surface electromyography (sEMG) of pelvic floor activity will be recorded during 60- second vibrations of different intensity.

Secondary outcome [1]

Change in activity of the rectus abdominis assessed by means of surface electromyography (sEMG) during voluntary contraction of pelvic floor muscles.
.

Timepoint [1]

Change in activity of the rectus abdominis assessed during voluntary contraction of pelvic floor muscles.

Secondary outcome [2]

Change in activity of the gluteus maximus assessed by means of surface electromyography (sEMG) during voluntary contraction of pelvic floor muscles

Timepoint [2]

Change in activity of the gluteus maximus assessed during voluntary contraction of pelvic floor muscles.

Secondary outcome [3]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Silesia

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Jerzy Kukuczka Academy of Physical Education

Address [1]

72a Mikolowska Street
40-065 Katowice

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Other collaborator category [1]

University

Name [1]

Faculty and Department of Basic Biomedical Sciences of the Medical University of Silesia in Katowice

Address [1]

Kasztanowa 3 Street
41-200 Sosnowiec

Country [1]

Poland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Research Ethics Committee from the Jerzy Kukuczka Academy of Physical Education in Katowice

Ethics committee address [1]

72a Mikolowska Street 
, 40-065 Katowice

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

24/11/2017

Approval date [1]

05/12/2017

Ethics approval number [1]

1/2017

Summary

Brief summary

Whole-body vibration training (WBV) and stochastic resonance whole-body vibration  provide valuable assistance in  physiotherapy. Some researchers report on the use of mechanical vibration for neuromuscular stimulation in women with postpartum stress urinary incontinence  due to weakened pelvic floor muscles (PFM). Basic research is needed to determine the effect of different intensity vibrations on the PFM with the ultimate aim of developing effective therapeutic strategies. Our study objective is to experimentally select such synchronous whole-body vibration and stochastic resonance whole-body vibration parameters that might help increase voluntary and reflex PFM activity. We will compare the effects of six different vibration intensities in young continent women..

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Daria Chmielewska

Address

Faculty of Physiotherapy, Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland

Country

Poland

Phone

+48691951906

Fax

[email protected]

Contact person for public queries

Name

Magdalena Stania

Address

Faculty of Physiotherapy, Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland

Country

Poland

Phone

+48694979640

Fax

[email protected]

Contact person for scientific queries

Name

Daria Chmielewska

Address

Faculty of Physiotherapy, Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland

Country

Poland

Phone

+48691951906

Fax

[email protected]

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.	Type	Citation	Link	Email	Other Details	Attachment
1795	Ethical approval					374188-(Uploaded-05-04-2019-00-52-58)-Study-related document.pdf

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

Trial Review

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