- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520396
Combined Effects of Swiss Ball Exercises and Diaphragmatic Breathing in Pregnant Females
Combined Effects of Swiss Ball Exercises and Diaphragmatic Breathing on Stress Urinary Incontinence, Pelvic Floor Muscle Strength and Quality of Life 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Itefaq Hospital and Zia Hospital
-
Contact:
- Masooma Saleem, MSPT WH
- Phone Number: 03320711342
- Email: masooma.saleem@riphah.edu.pk
-
Principal Investigator:
- Emaan jamil, MSPT WH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 lips for 3-4 seconds.
During the breathing, patient will hold onto pelvic contractions kept on for 10-15 minutes.
|
kegels exercises will be considered the baseline treatment for both groups
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.
|
|
Active Comparator: swiss ball exercises
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.
|
kegels exercises will be considered the baseline treatment for both groups
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
|
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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Masooma Saleem, MSPT WH, Riphah International University
Publications and helpful links
General Publications
- Sangsawang B, Sangsawang N. Stress urinary incontinence in pregnant women: a review of prevalence, pathophysiology, and treatment. International urogynecology journal. 2013;24:901-12.
- 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.
- 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, 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
- Urinary Incontinence, Stress
Other Study ID Numbers
- REC/RCR & AHS/25/0517
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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