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临床试验/NCT02748473
NCT02748473已完成不适用

Effectiveness of Adding Voluntary Pelvic Floor Muscle Contraction to a Pilates Exercises Program: An Assessor-masked Randomized Controlled Trial

Federal University of São Paulo0 个研究点目标入组 57 人开始时间: 2012年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
主要终点
change in Oxford Scale

研究概览

简要总结

Adding voluntary pelvic floor muscle contraction to a Pilates exercises program can improve the pelvic floor muscle strength on sedentary nulliparous women.

详细描述

Introduction

The purpose of this study was to evaluate the effectiveness of adding voluntary pelvic floor muscle contraction (PFMC) contraction to a Pilates exercise program on sedentary nulliparous women.

Methods: Fifty-seven healthy nulliparous and physically inactive women were randomized to Pilates exercise program (PEP) with or without PFMC. Forty-eight women concluded this study (24 participants for each group). Every women evaluated before and after the PEP, by a one physiotherapist and an urogynecologist (UG). Both professionals were not revealed to them. This physiotherapist measured their pelvic floor muscle strength by using both, a perineometer (Peritron) and vaginal palpation (Oxford Scale) . The UG, who performed 3D perineal ultrasound exams, collected their data and evaluated the results for pubovisceral muscle thickness and the levator hiatus (LA) area. Both professional were masked to the group allocation. The protocol for both groups consisted of 24 bi-weekly 1-h individual sessions of Pilates exercises, developed by another physiotherapist who is specialized in PFM rehabilitation and Pilates technique.

Group I: Pilates exercise program (PEP), involving only the Pilates exercises protocol without any instruction of a voluntary pelvic floor muscle contraction. I other words, the researcher had, under no circumstance, never explained anything about a voluntary pelvic floor muscle contraction during the Pilates exercise performance.

Group II: Pilates exercises program with voluntary pelvic floor muscle contraction (PEP+PFMC) composed of a Pilates exercises program with voluntary pelvic floor contractions. This included maximum contraction of the pelvic floor muscles during expiratory period with 5 repetitions alternately, thus avoiding any muscle exhaustion pelvic floor that could happen.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
Female
接受健康志愿者
是

入选标准

  • •healthy women (without any gynecologic/neurologic disease)
  • •sedentary women (do not practice regularly physical activities)
  • •nulliparous,
  • •on reproductive age
  • •with no history of pelvic floor disorders
  • •capable to perform correct PFMC.

排除标准

  • •Women were not included if they were not able to perform a correct PFMC.
  • •Potential subjects were excluded if they had chronic degenerative diseases affecting muscular and nerve tissues, diabetes, cerebrovascular disease or overt neurological conditions,
  • •pregnancy,
  • •autoimmune connective tissue disorders
  • •had previously undergone pelvic floor re-education programs and/or pelvic floor surgery.

研究组 & 干预措施

pelvic floor muscle strength

Other

evaluated pelvic floor muscle strength before and after Pilates exercises program on sedentary nulliparous women

干预措施: Pilates Exercises program (Other)

pelvic floor muscle strength

Other

evaluated pelvic floor muscle strength before and after Pilates exercises program on sedentary nulliparous women

干预措施: Pelvic floor muscle strength (Other)

pelvic floor muscle strength

Other

evaluated pelvic floor muscle strength before and after Pilates exercises program on sedentary nulliparous women

干预措施: 3D perineal ultrasound (Other)

Device: 3D perineal ultrasound

Other

evaluated the pubovisceral muscle thickness and the levator hiatus area before and after Pilates exercises program on sedentary nulliparous women

干预措施: Pilates Exercises program (Other)

Device: 3D perineal ultrasound

Other

evaluated the pubovisceral muscle thickness and the levator hiatus area before and after Pilates exercises program on sedentary nulliparous women

干预措施: 3D perineal ultrasound (Other)

结局指标

主要结局

change in Oxford Scale

时间窗: baseline and 3 months

evaluated the oxford scale

次要结局

  • change in pubovisceral muscle thickness(baseline and 3 months)
  • change in levator hiatus area(baseline and 3 months)
  • change in vaginal pressure(baseline and 3 months)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiza Torelli de Souza

Principal Investigator

Federal University of São Paulo

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