Effect of PEFLOW on PFM Function Recovery of Postpartum Women
6 juli 2022 bijgewerkt door: Sun Xiuli, Peking University People's Hospital
Effect of Pelvic Floor Workout on Pelvic Floor Muscle Function Recovery of Postpartum Women
The purpose of this study is to explore the correlation between women's pelvic floor function with their overall state of bodily functions, including body composition, physical activity levels, trunk muscle endurance, body posture, vaginal and gut microbes.
The main intervention of this study is a set of global training which Includes the strength, endurance, flexibility, stability and flexibility training on the diaphragm, abdominal, lower back, as well as pelvic floor muscles, on the basis Kegel training.
The primary destination of global training is to shorten the cycle of postpartum pelvic floor functional recovery, improve the effect of maternal training, and convenient in clinical promotion.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
Training for 2 times a week, for 12 weeks leading by a specific physiotherapist.The training intensity was evaluated by RPE self-induced fatigue scale.
Studietype
Ingrijpend
Inschrijving (Verwacht)
260
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Xiuli Sun, PHD
- Telefoonnummer: 010-88324354
- E-mail: sunxiuli03351@126.com
Studie Locaties
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Beijing
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Beijing, Beijing, China, 100044
- Werving
- The Peking University People's Hospital
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Contact:
- Hongmei ZHU, doctor
- Telefoonnummer: 010-88324354
- E-mail: 1209304228@qq.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 50 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Newly born women within 42 days to 3 months after delivery, after the end of puerperium, initial postpartum review and pelvic floor professional outpatient screening, found that pelvic floor muscle strength decreased (Oxford Oxford muscle strength ≤ grade 3);
- Healthy before pregnancy without pregnancy complications;
- Convenient transportation, familiar with the Internet;
- Be in good condition and be able to complete the exercise program;
- Complete clinical baseline data;
- Agreed to conduct the study and signed the informed consent.
Exclusion Criteria:
- Patients with stage Ⅲ and Ⅳ pelvic organ prolapse;
- Severe urinary incontinence;
- lochia, vaginal bleeding and pregnancy;
- Serious medical diseases, such as cardiac dysfunction who wear pacemakers, neurological diseases, cognitive impairment and other pathological conditions;
- Cannot complete the intervention program;
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Routine education group
Routine education, including postpartum lifestyle, Kegel exercise and Knack method.
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Behavior guidance on pelvic floor muscle function training , including Knack method education , and Kegel exercise and other pelvic floor muscle training methods were taught to postpartum women.
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Experimenteel: Global training group
Global training was added on the basis of routine education.
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Behavior guidance on pelvic floor muscle function training , including Knack method education , and Kegel exercise and other pelvic floor muscle training methods were taught to postpartum women.
Global training was added on the basis of control group.
The 30min-training plan is divided into 9 sections, of which, groups 1 to 8, each group takes about 3 minutes, the ninth group is cool down section, including stretching for 5 minutes and foam axis stretching for 1 minute.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum
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The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice.
Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction.
The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contracion.
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Baseline; After 12 week training or 6th month postpartum
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Change from Baseline pelvic floor electrophysiology at 6 months or after 12 weeks training
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum
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We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.
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Baseline; After 12 week training or 6th month postpartum
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Change from Baseline pelvic floor muscle strength at 1 year postpartum
Tijdsspanne: Baseline; 1 year postpartum
|
The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice.
Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction.
The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contracion.
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Baseline; 1 year postpartum
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Change from Baseline pelvic floor electrophysiology at 1 year postpartum
Tijdsspanne: Baseline; 1 year postpartum
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We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.
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Baseline; 1 year postpartum
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The occurrence of SUI
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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SUI is defined by SUI symptoms or a positive result of the stress test.
Before the stress test, participants are suggested to keep fully bladder.
Positive result of the stress test is defined as involuntarily urinary leakage when asked to cough in the lithotomy position.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from Pelvic floor ultrasound indicators
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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LAM thickness, diameter of the levator hiatus and levator hiatus area
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from Pelvic Organ Prolapse Quantitation
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Pelvic Organ Prolapse Quantitation is measured by callipers
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from Physical activity levels
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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We use International Physical Activity Questionnaire score to measure the overall physical activity level during postpartum period.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from pelvic sagittal rotation degree
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The quantitative measurement of pelvic sagittal rotation degree on X-ray was analyzed which includes the pelvic tilt angle , the sacral slope angle, the difference of sacral slope and pelvic tilt, the ratio of the pelvic tilt angle to the sacral slope angle, the ratio of the pelvic tilt angle to the pelvic incidence angle and sacral-femoral distance.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from body composition
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Body composition analysis is measured which mainly includes Body Mass Index（BMI）based on height and weight in kg/m^2.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from body strength
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Hand grip strength and trunk endurance are measured to describe body strength.
Hand grip strength was measured by JAMAR Plus+ grip gauge.
The measurement accuracy is 0.1kg.
The participants should not have visible hand defects.
The grip gauge should be adjusted before measurement.
When the paticipants holds the grip gauge, the second knuckle of the index finger should be at 90 degrees.
At the same time, mark the best position of each hand on the grip meter.
Before measurement, the participants should remove wrist jewelry to avoid injury.
And the left and right hand are measured alternately for 3 times.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from Pelvic Floor Distress Inventory（PFDI-20）Questionnaire Score
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) is the short-form version of the Pelvic Floor Distress Inventory (PFDI).Since it is comprised of the UDI-6, POPDI-6, and the CRADI-8, the PFDI-20 includes 20 questions.The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100.The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from PFIQ-7 Questionnaire Score
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a shortened, less comprehensive version of the Pelvic Floor Impact Questionnaire (PFIQ).To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3.The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300.
A lower score means there is a lesser effect on quality of life.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from FSFI-6 Questionnaire Score
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The 6-item Female Sexual Function Index (FSFI) is a short form of the original 19-item FSFI that measures sexual function in women.It comprises six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Desire and satisfaction items are rated on a 5-point Likert scale, ranging from 1 to 5, and the other items are rated on a 6-point Likert scale, ranging from 0 to 5. Total scores range from 2 to 30, with lower scores indicating worse sexual functioning.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Change from the Pittsburgh Sleep Quality Index (PSQI) Score
Tijdsspanne: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The sum of scores for these seven components yields one global score.
The 18 items consist of 7 components, and each component is scored according to the grade of 0 ~ 3. The cumulative score of each component is the total score of PSQI, and the total score range is 0~2l.
The higher the score, the worse the sleep quality.
It takes 5 to 10 minutes for the participants to complete the question.
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Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
2 november 2021
Primaire voltooiing (Verwacht)
30 juni 2023
Studie voltooiing (Verwacht)
30 juni 2023
Studieregistratiedata
Eerst ingediend
1 december 2021
Eerst ingediend dat voldeed aan de QC-criteria
29 januari 2022
Eerst geplaatst (Werkelijk)
1 februari 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 juli 2022
Laatste update ingediend die voldeed aan QC-criteria
6 juli 2022
Laatst geverifieerd
1 juli 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PKUPH6
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Ja
Beschrijving IPD-plan
(1)Date of disclosure of raw data: December 2023.
Data content: original recorded data and research proposals; (2) Ways or means of sharing IPDs, contact the researchers.
IPD-tijdsbestek voor delen
2 years
IPD-toegangscriteria voor delen
contact the researchers
IPD delen Ondersteunend informatietype
- Leerprotocool
- Klinisch onderzoeksrapport (CSR)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .