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Effect of PEFLOW on PFM Function Recovery of Postpartum Women

6 luglio 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

260

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Beijing
      • Beijing, Beijing, Cina, 100044
        • Reclutamento
        • The Peking University People's Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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;

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Routine education group
Routine education, including postpartum lifestyle, Kegel exercise and Knack method.
Comportamentale: 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.
Sperimentale: Global training group
Global training was added on the basis of routine education.
Comportamentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The occurrence of SUI
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking University People's Hospital

Collaboratori

Peking University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 novembre 2021

Completamento primario (Anticipato)

30 giugno 2023

Completamento dello studio (Anticipato)

30 giugno 2023

Date di iscrizione allo studio

Primo inviato

1 dicembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

29 gennaio 2022

Primo Inserito (Effettivo)

1 febbraio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 luglio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 luglio 2022

Ultimo verificato

1 luglio 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PKUPH6

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Descrizione del piano IPD

(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.

Periodo di condivisione IPD

2 years

Criteri di accesso alla condivisione IPD

contact the researchers

Tipo di informazioni di supporto alla condivisione IPD

  • Protocollo di studio
  • Relazione sullo studio clinico (CSR)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Prove cliniche su Active Comparator: Routine education group

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Malattie rare

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