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临床试验/NCT07551674
NCT07551674招募中不适用

Investigation of the Effects of Pelvic Floor Muscle Training Applied Via Action Observation Method Accompanied by Metaphorical Imagery on Urinary Incontinence in Geriatric Women

Fenerbahce University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Mini-Mental State Examination

研究概览

简要总结

This clinical trial investigates the effects of a 12-week Pelvic Floor Muscle Training (PFMT) program applied via Action Observation Therapy (AOT) with metaphorical imagery on urinary incontinence, quality of life, and treatment adherence in geriatric women. The study will be conducted between June 2025 and June 2026 in nursing homes in Istanbul, targeting women aged 65 and older who are diagnosed with stress or stress-predominant mixed urinary incontinence, possess normal cognitive function (Standardized Mini Mental Test score ≥ 24), and walk independently. Eligible participants will be divided into groups, where both will undergo a progressive exercise regimen involving twice-weekly 45-50 minute group sessions that advance from supine positions to standing and jumping movements. However, the AOT study group will uniquely perform these exercises while observing and imagining projected metaphor-themed visuals to enhance motor learning and motivation. Efficacy will be evaluated pre- and post-intervention using various standardized tools, including the Pelvic Floor Distress Inventory-20, a 24-hour pad test, the Incontinence Severity Index, the Movement Imagery Questionnaire-3, and the Incontinence Quality of Life Scale, to comprehensively assess improvements in incontinence severity, functional status, and overall well-being.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with stress or stress-predominant mixed urinary incontinence by a physician
  • Women aged 65 years and older
  • Literate in Turkish to understand, interpret, and answer the questionnaires
  • Scoring 24 or higher on the Mini-Mental State Examination (MMSE)
  • Able to walk independently without the use of any walking aids (assistive devices)
  • Having signed the informed consent form

排除标准

  • Received pelvic floor muscle training within the past 6 months
  • Presence of fecal incontinence
  • Current genitourinary infection or use of medication for urinary incontinence
  • History of urinary incontinence surgery or presence of symptomatic pelvic organ prolapse
  • Presence of neurological, orthopedic, psychiatric, hematological, or cardiovascular conditions that would preclude participation in exercise
  • Body mass index (BMI) ≥ 25 kg/m²
  • Hearing or visual impairments that would negatively affect participation
  • Presence of hematuria, urethral and/or bladder fistula, or a history of pelvic surgery

研究组 & 干预措施

Pelvic Floor Muscle Training program

Experimental

Exercise

干预措施: Pelvic Floor Muscle Training program (Other)

Pelvic Floor Muscle Training via Action Observation Therapy

Experimental

Exercise with AOT

干预措施: Pelvic Floor Muscle Training via Action Observation Therapy (Other)

结局指标

主要结局

Mini-Mental State Examination

时间窗: Baseline and after 12-weeks

Pelvic Floor Distress Inventory

时间窗: Baseline and after 12-weeks

The Incontinence Severity Index

时间窗: Baseline and after 12-weeks

Movement Imagery Questionnaire-3

时间窗: Baseline and after 12-weeks

次要结局

  • Geriatric Self-Efficacy Index for Urinary Incontinence(Baseline and after 12-weeks)
  • Incontinence Quality of Life Questionnaire(Baseline and after 12-weeks)

研究者

发起方
Fenerbahce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arzu Razak Ozdinçler

PROF DR

Fenerbahce University

研究点 (1)

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