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

NCT07520396 | Recruiting

• 1 other identifier: REC/RCR & AHS/25/0517
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Strength; Quality of Life; Urinary Incontinence

Keywords

swiss ball exercises; diaphragmatic breathing; quality of life; pelvic floor muscle strength; stress urinary incontinence

Outcome Measures

Primary Outcomes (3)

• Incontinence questionnaire

  . 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.

  8 weeks

• Kings health questionnaire

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

  8 weeks

• Perinometer or manual muscle testing

  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.

  8 weeks

Study Arms (2)

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.

Other: kegels exercises; Other: Diaphragmatic breathing

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.

Other: kegels exercises

Interventions

kegels exercises OTHER

kegels exercises will be considered the baseline treatment for both groups

Diaphragmatic breathing; swiss ball exercises

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.

Diaphragmatic breathing

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: 20 to 40 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Itefaq Hospital and Zia Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (4)

• Sangsawang B, Sangsawang N. Stress urinary incontinence in pregnant women: a review of prevalence, pathophysiology, and treatment. International urogynecology journal. 2013;24:901-12.

  BACKGROUND

• Tennstedt SL, Fitzgerald MP, Nager CW, Xu Y, Zimmern P, Kraus S, et al. Quality of life in women with stress urinary incontinence. International Urogynecology Journal. 2007;18:543-9.

  BACKGROUND

• Kamel DM, Ibrahiem SH, Ashmawi HS, Aboelmagd SR. Stabilization Exercises Combined with Pelvic Floor Exercises for Pregnancy Related Low Back Pain: A Randomized Clinical Trial. Egyptian Journal of Physical Therapy. 2024;19(1):1-7.

  BACKGROUND

• Adnan H, Ghous M, Ur Rehman SS, Yaqoob I. The effects of a static exercise program verses Swiss ball training for core muscles of the lower back and pelvic region in patients with low back pain after child delivery. A single blind randomized control trial. Journal of the Pakistan Medical Association. 2021;71(4):1-13.

  BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Masooma Saleem, MSPT WH

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: August 31, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)