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CTRI Number  CTRI/2024/07/070791 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
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   A Clinical trial to study how Pilates can help Female volleyball players with bladder control and jumping ability 
Scientific Title of Study   Effect Of Pilates On Stress Urinary Incontinence And Jump Performance Among Female Volleyball 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  Janani V 
Designation  Post Graduate Student 
Affiliation  SRM College Of Physiotherapy SRM Institute of Science and Technology 
Address  Room No:PT05 5th floor SRM College Of Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram

Kancheepuram
TAMIL NADU
603203
India 
Phone  7010522507  
Fax    
Email  jv8948@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  S F Mariyam Farzana 
Designation  Assistant Professor 
Affiliation  SRM College Of Physiotherapy SRM Institute of Science and Technology 
Address  Room No:PT05 5th floor SRM College of Physiotherapy SRM Medical College Hospital and Research Center SRM NAGAR Potheri Kattankulathur Chengalpattu Kancheepuram

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884654310  
Fax    
Email  mariyamf@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  S F Mariyam Farzana 
Designation  Assistant Professor 
Affiliation  SRM College Of Physiotherapy SRM Institute of Science and Technology 
Address  Room No:PT05 5th floor SRM College of Physiotherapy SRM Medical College Hospital and Research Center SRM NAGAR Potheri Kattankulathur Chengalpattu Kancheepuram

Kancheepuram
TAMIL NADU
603203
India 
Phone  9884654310  
Fax    
Email  mariyamf@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu Kancheepuram Tamil Nadu India 603203 
 
Primary Sponsor  
Name  Janani V 
Address  Room No:PT05 5th floor SRM College of Physiotherapy SRM Medical College Hospital and Research Center SRM NAGAR Potheri Kattankulathur Chengalpattu Kancheepuram Tamil Nadu India 603203 
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 
Dr S F Mariyam Farzana MPT  SRM Department Of Sports And Physical Education  SRM Institute Of Science And Technology Kattankulathur Chengalpattu 603203
Kancheepuram
TAMIL NADU 		 9884654310

mariyamf@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital And Research Centre Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N393||Stress incontinence (female) (male),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pilates Exercise  Patient education, Kegels and the Pilates will be taught. A Session will be 40 to 50 minutes performed 3 times a week for 8 weeks .  
Comparator Agent  Without Pilates Exercise   Patient education and Kegels will be taught.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Age 18-25 years
Female volleyball players at university level
Subjects who have been training volleyball more than 2 years
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 recently(1year) undergone surgical treatment of gynecological and urological illnesses
Players who have undergone recent fractures in the upper and lower limb
Recurrent urinary tract infections
Pelvic malignancy
Pelvic organ prolapse
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
International consultation for incontinence questionnaire (ICIQ SF)
 		 Pretest
Post test (after duration of 8 weeks)
 
 
Secondary Outcome  
Outcome  TimePoints 
Vertical jump test
 		 Pretest
posttest (after duration of 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)   15/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
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  
•The participants will be screened according to the inclusion and exclusion criteria. The research objectives will be clearly explained to the participants and grouped as Group A(n-30) and Group B(n-30).
•The participants will be included in the study and informed consent will be obtained.
•After that, both group A and group B subjects will be conducted a pre-test in which the stress urinary incontinence will be assessed through the INTERNATIONAL CONSULTATION FOR INCONTINENCE QUESTIONNAIRE(ICIQ) and the performance will be assessed through VERTICAL JUMP TEST. Then the values and scoring are recorded.
•For group A, Patient education and Kegels will be taught.
•For group B, along with the patient education, Kegels and the Pilates will be taught. A Session will be 40 to 50 minutes performed 3 times a week for 8 weeks.
•After 8 weeks of Pilates, again post-test will be conducted to assess the stress urinary incontinence with INTERNATIONAL CONSULTATION FOR INCONTINENCE QUESTIONNAIRE(ICIQ) and performance will be assessed through VERTICAL JUMP TEST. Then the scoring will be recorded.
•Then the post-test is compared with pre-test.
 
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