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临床试验/NCT02676700
NCT02676700已完成不适用

The Effect of Pelvic Floor Muscle Training With or Without Kaatsu Training for Women With Stress Urinary Incontinence

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form )

研究概览

简要总结

This study examines the effect of adding so called Kaatsu training to pelvic floor muscle training. Half the participants will perform Kaatsu training on their thigh muscles followed by pelvic floor muscle training. The other half will receive pelvic floor muscle training alone.

详细描述

Stress urinary incontinence (SU) is a common problem among adult women . Pelvic floor muscle training (PFMT) is recommended as first line treatment but PFMT is not always efficient and some women cannot comply with the intensive PFMT needed to obtain effect because of weakened or damaged muscles caused by vaginal delivery and age related changes.

Hypothetically alternative methods could be used to enhance the effect of a strength-training program. A low intensity training program with a simultaneous partial occlusion of the blood supply for the training muscle, so called "Kaatsu" training has been found to increase muscle strength faster than ordinary strength training but with much less effort. It seems difficult to make occlusion of the pelvic floor muscles during PFMT but a study found that low intensity training of the quadriceps femoris with partial occlusion of the blood supply did not only increase muscle strength of the quadriceps femoris muscle but also of the biceps humeri muscle if that muscle was trained with low-load training and no occlusion in the same training session. The specific reason for this this "cross-transfer effect" could not be fully explained but it was believed to be caused by a systemic effect caused by growth hormones. The aim of this study is therefore to examine if Kaatsu training offered in relation to a low-load PFMT program can increase the effect of PFMT in women with SUI

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ICIQ-SF ≥ 12
  • Urinary stress incontinence
  • Ability to contract pelvic floor muscles
  • Normal bladder capacity and normal flow during micturition with at least one micturition of > 350 ml

排除标准

  • Urgency urinary incontinence
  • Cognitive problems
  • Physical inability to perform Kaatsu program
  • Inability to understand and read Danish

研究组 & 干预措施

Pelvic floor muscle training and Kaatsu

Active Comparator

Participants are instructed in the PFMT program by primary investigator and instructed in Kaatsu training by a research nurse. The Kaatsu training is performed 4 times a week before PFMT. The program includes 2 x 15 knee extensions with partly occlusion of the blood supply to the thigh. Training level is >12 RM. Training is performed sitting on a chair and rubber bands are used to increase resistance. Training adherence and bother with the training is reported in a training diary. At week 6 the research nurse adjusts the training program.

The PFMT program includes three sets of 10 contractions with an intensity of >12 RM and is to be performed 4 times a week.

Training adherence and any bother with the training is reported in a training diary.

干预措施: Pelvic floor muscle training and Kaatsu (Behavioral)

pelvic floor muscle training

Active Comparator

Participants perform the same PFMT program as the intervention group. The PFMT program includes three sets of 10 contractions with an intensity of >12 RM and is to be performed 4 times a week.

Training adherence and any bother with the training is reported in a training diary.

干预措施: Pelvic floor muscle training (Behavioral)

结局指标

主要结局

ICIQ-SF (International Consultation on Incontinence Questionnaire - Short Form )

时间窗: 12 weeks

Subjective measure of severity of urinary loss and impact on quality of life

次要结局

  • PGI-I (Patient Global Index of Improvement scale)(6 and 12 weeks)
  • ICIQ-SF(6 weeks)
  • UPR (Urethral Pressure Reflectometry)(12 weeks)
  • Three days bladder diary(6 and 12 weeks)
  • VAS (Visual Analog Scale)(6 and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulla Due

Physiotherapist, M.Sc, Ph.D.

Herlev Hospital

研究点 (2)

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