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
|
|
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
|
|
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. |