Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12615000966594 |
Date of registration:
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15/09/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Bioelectrical activity of the pelvic floor muscles during synchronous whole-body vibration - a randomized controlled study
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Scientific title:
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Bioelectrical activity of the pelvic floor muscles during synchronous whole-body vibration in nulliparous continent women - a randomized controlled study
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Date of first enrolment:
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06/05/2014 |
Target sample size:
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36 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12615000966594.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Poland
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Contacts
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Name:
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Dr Magdalena Stania
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Address:
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Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland
Poland |
Telephone:
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+48694979640 |
Email:
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m.stania@awf.katowice.pl |
Affiliation:
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Name:
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Dr Magdalena Stania
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Address:
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Department of Physiotherapy Basics, Jerzy Kukuczka Academy of Physical Education, Mikolowska 72a, 40-065 Katowice, Poland
Poland |
Telephone:
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+48694979640 |
Email:
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m.stania@awf.katowice.pl |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. nulliparous continent women
2. age 19-25
3. subject's consent to participate in the study
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
Age minimum:
19 Years
Age maximum:
25 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Renal and Urogenital - Normal development and function of male and female renal and urogenital system
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Musculoskeletal - Other muscular and skeletal disorders
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Renal and Urogenital - Other renal and urogenital disorders
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muscle activity in nulliparous continent women ;incontinence; muscle activity in nulliparous continent women incontinence
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Intervention(s)
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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
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Primary Outcome(s)
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Mean and median frequency of the pelvic floor muscles sEMG [During the 90-second sEMG recordings]
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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) [Pelvic floor surface electromyography (sEMG) activity was recorded during three experimental trials limited to 30s, 60s and 90s.]
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Secondary Outcome(s)
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nil[nil]
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Source(s) of Monetary Support
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The Jerzy Kukuczka Academy of Physical Education in Katowice
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Ethics review
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Status: Approved
Approval date:
Contact:
The Research Ethics Committee from the Jerzy Kukuczka Academy of Physical Education in Katowice
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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