Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000966594
Ethics application status
Approved
Date submitted
16/07/2015
Date registered
15/09/2015
Date last updated
15/09/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bioelectrical activity of the pelvic floor muscles during synchronous whole-body vibration - a randomized controlled study
Scientific title
Bioelectrical activity of the pelvic floor muscles during synchronous whole-body vibration in nulliparous continent women - a randomized controlled study
Secondary ID [1] 287099 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
muscle activity in nulliparous continent women 295620 0
incontinence 296046 0
Condition category
Condition code
Renal and Urogenital 295899 295899 0 0
Normal development and function of male and female renal and urogenital system
Musculoskeletal 296029 296029 0 0
Other muscular and skeletal disorders
Renal and Urogenital 296030 296030 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study was to evaluate bioelectrical activity of the pelvic floor muscles during synchronous low- and high-intensity whole-body vibration in three trials of varying duration (30s, 60s and 90s). Another aim was to assess pelvic floor muscle fatigue during 90s whole-body vibration. The study participants were young continent women.

Intervention:
Group I and II subjects participated in synchronous whole-body vibrations which were carried out on a vibration platform (Fitvibe 600, Gymna Uniphy N.V.) producing vertical oscillations. The frequency and peak-to-peak displacement of vibration were set individually for each group, i.e. 2 mm/20 Hz for group I and 4 mm/40 Hz for group II. Test participants were in a static squat position during the exercises. Each subject was asked to stand on the platform, loading their feet uniformly, with the knee and hip joints bent at 35 degrees and the upper extremities stretched horizontally forwards, holding on to a railing. Control participants (group III) performed static squat exercises similar to those used in the study groups I and II but without the concurrent application of vibrations. Three static squat exercise trials of varying duration (30s, 60s and 90s) were performed in a randomized order. A 10-min rest period was used between trials in order to eliminate any potential fatigue.

Measurements:
Pelvic floor surface electromyography (sEMG) activity was recorded using a vaginal probe during three experimental trials limited to 30s, 60s and 90s in accordance with SENIAM recommendations (Surface ElectroMyoGraphy for the Non- Invasive Assessment of Muscles).
The experiment consisted of two phases: 1/ the maximal voluntary contractions (MVC) procedure to recruit pelvic floor muscles and 2/ three static exercise trials of varying duration (30s, 60s, 90s) performed in a randomized order to determine PFM activity during (groups I, II) or without (group III) WBV. During the first phase, each participant was instructed to perform MVC of the pelvic floor muscles as forcefully as possible for about 5 seconds. Three attempts were made with 60-second rests between each contraction to reduce the effect of muscle fatigue. The MVC procedure to recruit pelvic floor muscles was carried out in supine lying, the hip and knee were positioned at 30° and 90° of flexion, respectively. The positions were controlled with the goniometer.
The mean amplitude and variability of the signal were normalized to the Maximal Voluntary Contraction. The mean amplitude as well as the mean and median frequency of the sEMG signal were additionally measured to determine the effect of fatigue during the 90-second sEMG recordings. sEMG probe was placed by gynecologist; testing procedure was supervised by physiotherapist.
Intervention code [1] 292341 0
Prevention
Intervention code [2] 292342 0
Rehabilitation
Intervention code [3] 292459 0
Treatment: Other
Comparator / control treatment
Control participants (group III) performed static exercises similar to those used in the study groups I and II but without the concurrent application of vibrations.
Control group
Active

Outcomes
Primary outcome [1] 295572 0
Pelvic floor surface electromyography (sEMG) activity by means of intravaginal electrode.
Measured parameters: mean 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] 295572 0
Pelvic floor surface electromyography (sEMG) activity was recorded during three experimental trials limited to 30s, 60s and 90s.
Primary outcome [2] 295573 0
Mean and median frequency of the pelvic floor muscles sEMG
Timepoint [2] 295573 0
During the 90-second sEMG recordings
Secondary outcome [1] 315866 0
nil
Timepoint [1] 315866 0
nil

Eligibility
Key inclusion criteria
1. nulliparous continent women
2. age 19-25
3. subject's consent to participate in the study
Minimum age
19 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. a history of disequilibrium
2. acute inflammatory conditions and infections
3. epilepsy
4. cardiovascular diseases
5. acute phase of osteoarthritis
6. stress urinary incontinence
7. pregnancy
8. childbirth(s)
9. pelvic surgery
10. diabetes
11. hypertension
12. neurological abnormalities
13. urinary tract infection
14. elevated temperature
15. spinal pain
16. Body Mass Index over 30kg/m2

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)
Numbered envelopes

The main coordinator who allocated the participants to groups had envelopes, each containing a piece of paper marked with either group I, II or III. The physician selected and opened an envelope in the presence of a physiotherapist to see the symbol and then directed the participant to the corresponding group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by
appropriate website
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Shapiro-Wilk test was used to check the data for normal distribution, while variance homogeneity was assessed using the Levene test. Since several parameters failed to meet the assumption regarding the normal distribution of variables and variance homogeneity, nonparametric tests were used.
Friedman's two-way ANOVA for ranks was applied when the same parameter had been measured several times (k>=2) under different conditions on the same subjects. The Bonferroni post-hoc test, which reveals which means are significantly different from each other, was also performed. Inter-trial changes in the amplitude of the sEMG signal from the pelvic floor muscles were analysed using the Kruskal-Wallis ANOVA with the Tukey post hoc test.

Determination of sample size

Result distribution in a randomly selected sample was unimodal; skewness and flatness were lower than 2.5. Therefore center stratification and dispersion measure were best assessed with the arithmetic mean and standard deviation.
We assumed 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 was 10 patients. The target sample size was 36; 6 additional participants were to be recruited to account for dropouts (due to artifact signals of EMG). The actual sample size was 33. The study participants were randomly assigned to 3 groups (Group I – 12; Group II – 10, and Group III – 11).
Data analysis was performed with Statistica, version 10.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/05/2014
Actual
6/05/2014
Date of last participant enrolment
Anticipated
14/11/2014
Actual
14/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
33
Recruitment outside Australia
Country [1] 7034 0
Poland
State/province [1] 7034 0
Silesia

Funding & Sponsors
Funding source category [1] 291657 0
University
Name [1] 291657 0
The Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 291657 0
Poland
Primary sponsor type
University
Name
The Jerzy Kukuczka Academy of Physical Education in Katowice
Address
Mikolowska Street 72 40-065 Katowice
Country
Poland
Secondary sponsor category [1] 290331 0
None
Name [1] 290331 0
Address [1] 290331 0
Country [1] 290331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293181 0
The Research Ethics Committee from the Jerzy Kukuczka Academy of Physical Education in Katowice
Ethics committee address [1] 293181 0
Ethics committee country [1] 293181 0
Poland
Date submitted for ethics approval [1] 293181 0
23/11/2012
Approval date [1] 293181 0
13/12/2012
Ethics approval number [1] 293181 0
4/2012

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

Contacts
Principal investigator
Name 58818 0
Dr Magdalena Stania
Address 58818 0
Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland
Country 58818 0
Poland
Phone 58818 0
+48694979640
Fax 58818 0
Email 58818 0
[email protected]
Contact person for public queries
Name 58819 0
Magdalena Stania
Address 58819 0
Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland
Country 58819 0
Poland
Phone 58819 0
+48694979640
Fax 58819 0
Email 58819 0
[email protected]
Contact person for scientific queries
Name 58820 0
Magdalena Stania
Address 58820 0
Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland
Country 58820 0
Poland
Phone 58820 0
+48694979640
Fax 58820 0
Email 58820 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
SourceTitleYear of PublicationDOI
EmbaseBioelectrical activity of the pelvic floor muscles during synchronous whole-body vibration - A randomized controlled study Voiding dysfunction.2015https://dx.doi.org/10.1186/s12894-015-0103-9
N.B. These documents automatically identified may not have been verified by the study sponsor.