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临床试验/NCT07520396
NCT07520396招募中不适用

Combined Effects of Swiss Ball Exercises and Diaphragmatic Breathing on Stress Urinary Incontinence, Pelvic Floor Muscle Strength and Quality of Life in Pregnant Females.

Riphah International University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年8月31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
入组人数
42
试验地点
1
主要终点
Incontinence questionnaire

研究概览

简要总结

30 to 60 percent of the pregnant females experience stress urinary incontinence depending on various factors like trimester, parity and body weight. Stress urinary incontinence is a common yet often underreported condition affecting pregnant women, characterized by involuntary leakage of urine during physical activities such as coughing, sneezing, or exercising. Stress urinary incontinence majorly occurs due to increased intra-abdominal pressure and weakened pelvic floor muscles which are further strained during pregnancy. Despite its impact on quality of life, awareness and management remains inadequate. Strengthening the pelvic floor muscles plays a critical role in managing stress urinary incontinence and Swiss ball exercises have emerged as an effective and low impact method to improve core stability and pelvic floor muscle strength. These exercises engage deep abdominal and pelvic muscles in a functional and dynamic way, potentially enhancing both physical and psychological well-being during pregnancy.

. The study will be conducted as a randomized control trial involving females with stress urinary incontinence in Zia Hospital Lahore and Ittefaq Hospital Lahore. The study will be completed within 10 months of synopsis approval. A non-probability sampling technique will be employed and 42 patients will be enrolled after randomization. Participants will be divided into two groups. Group A will undergo a structured program involving Swiss ball exercises combined with diaphragmatic breathing. Group B will receive Swiss ball exercises without diaphragmatic breathing. Kegel exercises will be considered the baseline treatment. Outcome measures will include syptoms of stress urinary incontinence (using International Consultation Incontinence Questionnaire), pelvic floor muscle strength (assessed through standardized tools i.e. Modified Oxford Scale) and self-reported quality of life (using validated questionnaires i.e. King's Health Questionnaire). The data collected will be analyzed using IBM SPSS statistics version 25.

详细描述

30 to 60 percent of the pregnant females experience stress urinary incontinence depending on various factors like trimester, parity and body weight. Stress urinary incontinence is a common yet often underreported condition affecting pregnant women, characterized by involuntary leakage of urine during physical activities such as coughing, sneezing, or exercising. Stress urinary incontinence majorly occurs due to increased intra-abdominal pressure and weakened pelvic floor muscles which are further strained during pregnancy. Despite its impact on quality of life, awareness and management remains inadequate. Strengthening the pelvic floor muscles plays a critical role in managing stress urinary incontinence and Swiss ball exercises have emerged as an effective and low impact method to improve core stability and pelvic floor muscle strength. These exercises engage deep abdominal and pelvic muscles in a functional and dynamic way, potentially enhancing both physical and psychological well-being during pregnancy.

. The study will be conducted as a randomized control trial involving females with stress urinary incontinence in Zia Hospital Lahore and Ittefaq Hospital Lahore. The study will be completed within 10 months of synopsis approval. A non-probability sampling technique will be employed and 42 patients will be enrolled after randomization. Participants will be divided into two groups. Group A will undergo a structured program involving Swiss ball exercises combined with diaphragmatic breathing. Group B will receive Swiss ball exercises without diaphragmatic breathing. Kegel exercises will be considered the baseline treatment. Outcome measures will include syptoms of stress urinary incontinence (using International Consultation Incontinence Questionnaire), pelvic floor muscle strength (assessed through standardized tools i.e. Modified Oxford Scale) and self-reported quality of life (using validated questionnaires i.e. King's Health Questionnaire). The data collected will be analyzed using IBM SPSS statistics version 25.

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, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • Females with singleton pregnancy
  • Females with urinary incontinence
  • Age range between 20-40
  • Females with diagnosed with mild to moderate stress urinary incontinence
  • Females with weak pelvic floor muscles

排除标准

  • • Females who are not pregnant
  • Females who have had any previous history of hysterectomy
  • Females with placenta previa
  • Females with UTI
  • Females with preterm labor
  • Females with pelvic organ prolapse

研究组 & 干预措施

Diaphragmatic breathing

Experimental

There will be total 12 sessions carried for 6 weeks. 3-4 sessions will be given per week. In each session, patients will be exposed to moderate intensity Swiss ball exercises will include, Swiss ball wall squats, pelvic tilts, bridging with legs on Swiss ball and ball squeeze. Each exercise will be carried out in 3 sets of 10 repetitions for 20-25 minutes session. After each set, patient will be asked to follow the diaphragmatic breathing by deep inhaling through nose and exhaling with pursed lips for 3-4 seconds. During the breathing, patient will hold onto pelvic contractions kept on for 10-15 minutes.

干预措施: kegels exercises (Other)

Diaphragmatic breathing

Experimental

There will be total 12 sessions carried for 6 weeks. 3-4 sessions will be given per week. In each session, patients will be exposed to moderate intensity Swiss ball exercises will include, Swiss ball wall squats, pelvic tilts, bridging with legs on Swiss ball and ball squeeze. Each exercise will be carried out in 3 sets of 10 repetitions for 20-25 minutes session. After each set, patient will be asked to follow the diaphragmatic breathing by deep inhaling through nose and exhaling with pursed lips for 3-4 seconds. During the breathing, patient will hold onto pelvic contractions kept on for 10-15 minutes.

干预措施: Diaphragmatic breathing (Other)

swiss ball exercises

Active Comparator

There will be total 12 sessions carried for 6 weeks. 3-4 sessions will be given per week. In each session, patients will be exposed to moderate intensity Swiss ball exercises will include, Swiss ball wall squats, pelvic tilts, bridging with legs on Swiss ball and ball squeeze. Each exercise will be carried out in 3 sets of 10 repetitions for 20-25 minutes session.

干预措施: kegels exercises (Other)

结局指标

主要结局

Incontinence questionnaire

时间窗: 8 weeks

. ICIQ-UI SF is used for measuring frequency, volume and impact of urinary leakage. Also, that this tool is free for clinical and small-scale research use; larger studies or commercial entities may require permission. The scoring system ranges from 0-21 based on symptom, frequency or volume of the leaked urine.

Kings health questionnaire

时间窗: 8 weeks

KHQ is considered to be an easy tool to measure the quality of life affected by following 9 domains.

Perinometer or manual muscle testing

时间窗: 8 weeks

A perineometer is a medical which measures vaginal pressure during pelvic floor muscle contraction, giving a quantitative assessment. It is a precise and repeatable assessment protocol and provides visual feedback during training.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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