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NCT Number: NCT07520396

Combined Effects of Swiss Ball Exercises and Diaphragmatic Breathing in Pregnant Females

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Itefaq Hospital and Zia Hospital

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Emaan jamil, MSPT WH

PRINCIPAL_INVESTIGATOR

Masooma Saleem, MSPT WH

CONTACT

[email protected]

03320711342

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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

Exclusion criteria

  • • 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

Treatment and study plan

kegels exercises

Other

kegels exercises will be considered the baseline treatment for both groups

Diaphragmatic breathing

Other

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.

Primary outcomes

  1. Incontinence questionnaire

    Time frame: 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.

  2. Kings health questionnaire

    Time frame: 8 weeks

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

  3. Perinometer or manual muscle testing

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

imran amjad, phd

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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