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Effect of PEFLOW on PFM Function Recovery of Postpartum Women

6. Juli 2022 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

260

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Rekrutierung
        • The Peking University People's Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 50 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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;

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Routine education group
Routine education, including postpartum lifestyle, Kegel exercise and Knack method.
Verhalten: Active Comparator: Routine education group
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.
Experimental: Global training group
Global training was added on the basis of routine education.
Verhalten: Active Comparator: Routine education group
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.
Verhalten: Experimental: Global training group
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training
Zeitfenster: Baseline; After 12 week training or 6th month 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.
Baseline; After 12 week training or 6th month postpartum
Change from Baseline pelvic floor electrophysiology at 6 months or after 12 weeks training
Zeitfenster: Baseline; After 12 week training or 6th month postpartum
We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.
Baseline; After 12 week training or 6th month postpartum
Change from Baseline pelvic floor muscle strength at 1 year postpartum
Zeitfenster: 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.
Baseline; 1 year postpartum
Change from Baseline pelvic floor electrophysiology at 1 year postpartum
Zeitfenster: Baseline; 1 year postpartum
We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.
Baseline; 1 year postpartum

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The occurrence of SUI
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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.
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Pelvic floor ultrasound indicators
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
LAM thickness, diameter of the levator hiatus and levator hiatus area
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Pelvic Organ Prolapse Quantitation
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Pelvic Organ Prolapse Quantitation is measured by callipers
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Physical activity levels
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
We use International Physical Activity Questionnaire score to measure the overall physical activity level during postpartum period.
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from pelvic sagittal rotation degree
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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.
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from body composition
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Body composition analysis is measured which mainly includes Body Mass Index（BMI）based on height and weight in kg/m^2.
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from body strength
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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.
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Pelvic Floor Distress Inventory（PFDI-20）Questionnaire Score
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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.
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from PFIQ-7 Questionnaire Score
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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.
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from FSFI-6 Questionnaire Score
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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.
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from the Pittsburgh Sleep Quality Index (PSQI) Score
Zeitfenster: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
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.
Baseline; After 12 week training or 6th month postpartum；1 year follow-up

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Peking University People's Hospital

Mitarbeiter

Peking University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

2. November 2021

Primärer Abschluss (Voraussichtlich)

30. Juni 2023

Studienabschluss (Voraussichtlich)

30. Juni 2023

Studienanmeldedaten

Zuerst eingereicht

1. Dezember 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Januar 2022

Zuerst gepostet (Tatsächlich)

1. Februar 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juli 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juli 2022

Zuletzt verifiziert

1. Juli 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PKUPH6

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

(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-Sharing-Zeitrahmen

2 years

IPD-Sharing-Zugriffskriterien

contact the researchers

Art der unterstützenden IPD-Freigabeinformationen

  • Studienprotokoll
  • Klinischer Studienbericht (CSR)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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