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Effect of PEFLOW on PFM Function Recovery of Postpartum Women

2022년 7월 6일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

260

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Beijing
      • Beijing, Beijing, 중국, 100044
        • 모병
        • The Peking University People's Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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;

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Routine education group
Routine education, including postpartum lifestyle, Kegel exercise and Knack method.
행동: 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.
실험적: Global training group
Global training was added on the basis of routine education.
행동: 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.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
The occurrence of SUI
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Peking University People's Hospital

협력자

Peking University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 11월 2일

기본 완료 (예상)

2023년 6월 30일

연구 완료 (예상)

2023년 6월 30일

연구 등록 날짜

최초 제출

2021년 12월 1일

QC 기준을 충족하는 최초 제출

2022년 1월 29일

처음 게시됨 (실제)

2022년 2월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 7월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 7월 6일

마지막으로 확인됨

2022년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PKUPH6

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

(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 공유 기간

2 years

IPD 공유 액세스 기준

contact the researchers

IPD 공유 지원 정보 유형

  • 연구 프로토콜
  • 임상 연구 보고서(CSR)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Active Comparator: Routine education group에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Mauritania

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다