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

Official 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.

Overview

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.

Detailed description

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.

Interventions

• Other kegels exercises
  kegels exercises will be considered the baseline treatment for both groups
• Other Diaphragmatic breathing
  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 li

Primary outcome measures

• Incontinence questionnaire [Time frame: 8 weeks]
• Kings health questionnaire [Time frame: 8 weeks]
• Perinometer or manual muscle testing [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Itefaq Hospital and Zia Hospital — Lahore

Publications

• Sangsawang B, Sangsawang N. Stress urinary incontinence in pregnant women: a review of prevalence, pathophysiology, and treatment. Int Urogynecol J. 2013 Jun;24(6):901-12. doi: 10.1007/s00192-013-2061-7. Epub 2013 Feb 23. PMID 23436035
• Tennstedt SL, Fitzgerald MP, Nager CW, Xu Y, Zimmern P, Kraus S, Goode PS, Kusek JW, Borello-France D, Mallett V; Urinary Incontinence Treatment Network. Quality of life in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007 May;18(5):543-9. doi: 10.1007/s00192-006-0188-5. Epub 2006 Oct 12. PMID 17036169
• 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.
• Adnan H, Ghous M, Shakil Ur Rehman S, Yaqoob I. The effects of a static exercise programme versus 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. J Pak Med Assoc. 2021 Apr;71(4):1058-1062. doi: 10.47391/JPMA.784. PMID 34125743

Identifiers

NCT: NCT07520396 · REC/RCR & AHS/25/0517

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗