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CTRI Number  CTRI/2025/05/086808 [Registered on: 13/05/2025] Trial Registered Prospectively
Last Modified On: 12/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   How well hypopressive exercises work to reduce urine leakage in women who play high-impact sports  
Scientific Title of Study   Effectiveness of Hypopressive Exercises On Stress Urinary Incontinence among High Impact Sport Female Players.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs S F Mariyam Farzana 
Designation  Associate Professor  
Affiliation  SRM college of physiotherapy  
Address  Room no PT 5 5th FLOOR SRM College of Physiotherapy SRM Medical College Hospital and Research Center SRM Institute of Science and Technology Kattankulathur campus Chengalpettu district

Chennai
TAMIL NADU
602302
India 
Phone  9884654310  
Fax    
Email  mariyamf@srmist.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Mrs S F Mariyam Farzana 
Designation  Associate Professor  
Affiliation  SRM college of physiotherapy  
Address  Room no PT 5 5th FLOOR SRM College of Physiotherapy SRM Medical College Hospital and Research Center SRM Institute of Science and Technology Kattankulathur campus Chengalpettu district

Chennai
TAMIL NADU
602302
India 
Phone  9884654310  
Fax    
Email  mariyamf@srmist.edu.in  
 
Details of Contact Person
Public Query
 
Name  Mrs S F Mariyam Farzana 
Designation  Associate Professor  
Affiliation  SRM college of physiotherapy  
Address  Room no PT 5 5th FLOOR SRM College of Physiotherapy SRM Medical College Hospital and Research Center SRM Institute of Science and Technology Kattankulathur campus Chengalpettu district

Chennai
TAMIL NADU
602302
India 
Phone  9884654310  
Fax    
Email  mariyamf@srmist.edu.in  
 
Source of Monetary or Material Support  
Directorate of sports, sports complex, SRM University Tamil Nadu physical education and sports university, Melakottaiyur 
 
Primary Sponsor  
Name  Self 
Address  Room no PT 24 4th FLOOR SRM College of Physiotherapy SRM Medical College Hospital and Research Center SRM Institute of Science and Technology Kattankulathur campus Chengalpettu district  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Poojitha reddy  SRM sports complex   Kattankulathur campus Chengalpattu district
Chennai
TAMIL NADU 
9948862292

poojithareddy4501@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Center   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N364||Urethral functional and muscular disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hypopressive Exercises  Hypopressive exercises are a series of postural and breathing techniques designed to reduce intra-abdominal pressure and strengthen the core, particularly the deep abdominal and pelvic floor muscles. These exercises involve controlled apnea (breath-holding after exhalation) and rib cage expansion, creating a vacuum effect that lifts the pelvic organs. Unlike traditional abdominal workouts, hypopressives aim to engage muscles without straining them. They are commonly used for postnatal recovery, pelvic floor dysfunction, and improving posture. Regular practice can help prevent or alleviate conditions like stress urinary incontinence and pelvic organ prolapse. Frequency : 3 times a week Duration: 30 minutes  
Comparator Agent  Kegals exercises   Kegel exercises, also known as pelvic floor exercises, are designed to strengthen the pelvic floor muscles that support the bladder, uterus, rectum, and small intestine. These muscles play a vital role in urinary and bowel control, and improving their strength can help prevent or treat incontinence, especially in women after childbirth or during aging. Kegels involve repeatedly contracting and relaxing the pelvic floor muscles, much like stopping the flow of urine midstream. Frequency: 3 times a week Duration: 30 mins  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Players with High impact sports.
Women diagnosed with stress urinary incontinence in response to the items of (1 2 3) for stress score [questionnaire for female urinary incontinence diagnosis (QUID)].
 
 
ExclusionCriteria 
Details  Players who have undergone surgical treatment for abdominal, gynecological and urological treatment in recent times( 1 year).
Abdominal or inguinal hernias.
Players are having fractures to the ribs, upper limb, lower limbs and trunk.
Recurrent urinary tract infections.
Players who are under other treatment for SUI.
Pelvic malignancy.
Pregnancy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
International consultation for incontinence questionnaire (ICIQ – SF) (Reliability – 0.93)•

Pad test for incontinence 1 hour(Reliability- 0.65) 
International consultation for incontinence questionnaire (ICIQ – SF) (Reliability – 0.93)• Question no:1 2 3
Pad test for incontinence 1 hour(Reliability- 0.65).
Weight of pad is measured change in weight mare than 0.5 grams. 
 
Secondary Outcome  
Outcome  TimePoints 
Incontinence quality of life questionnaire ( Reliability- 0.93)  8 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/05/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Participants will be screened based on defined inclusion and exclusion criteria. Eligible female athletes will be selected and informed consent will be obtained. Participants will then be divided into two groups. Group A will perform hypopressive exercises and will serve as the intervention group. Group B will perform Kegel exercises and will serve as the control group.

Before starting the intervention, all participants will undergo a pre-test assessment. This will include the International Consultation on Incontinence Questionnaire Short Form, a one-hour pad test for urinary incontinence, and the Incontinence Quality of Life Questionnaire. Baseline scores will be recorded for both groups.

The intervention will last for eight weeks. Group A will follow the hypopressive exercise protocol. Sessions will be conducted twice per week, each lasting 30 minutes. These will be supervised training sessions focusing on posture and breathing techniques. The protocol will include spine elongation, chin retraction, shoulder joint activation, neutral pelvic alignment, ankle dorsiflexion, gravity shift, diaphragmatic breathing, and expiratory apnea. Exercises will be performed in various positions including supine, sitting, standing, kneeling, quadruped, and crook lying. Each session will consist of three sets of three repetitions.

Group B will follow a standard protocol of Kegel exercises targeting pelvic floor muscle strengthening.

After eight weeks, a post-test assessment will be conducted. The same tools used in the pre-test assessment will be administered again. These include the International Consultation on Incontinence Questionnaire Short Form, the one-hour pad test, and the Incontinence Quality of Life Questionnaire. Post-test scores will be compared with baseline scores to evaluate the effectiveness of the intervention.

The key parameters of the study include a frequency of two supervised sessions per week, with a focus on posture correction, breath control, and progressive muscle activation. The main objective is to reduce intra-abdominal pressure, strengthen pelvic floor muscles, and improve posture and core stability.
 
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