| CTRI Number |
CTRI/2025/12/099079 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“How Online and In-Person Pilates Exercises Help Reduce Urinary Leakage in Women Before Menopause.” |
|
Scientific Title of Study
|
Effects of remote and in-person pilates on urinary incontinence in pre-menopausal females: A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Tyagi |
| Designation |
MPT Student |
| Affiliation |
Amity Institute of health allied sciences |
| Address |
Amity Institute of health allied sciences, Amity university noida, sector 125, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8826103834 |
| Fax |
|
| Email |
bulbultyagi4347@gmail,com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of health allied sciences |
| Address |
Department of physiotherapy, Amity Institute of health allied sciences, Amity university noida, sector 125, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8826395132 |
| Fax |
|
| Email |
asharma39@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of health allied sciences |
| Address |
Department of physiotherapy, Amity Institute of health allied sciences, Amity university noida, sector 125, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8826395132 |
| Fax |
|
| Email |
asharma39@amity.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Isha Tyagi |
| Address |
Amity Institute of health allied sciences, Amity university noida, sector 125, Uttar Pradesh, 201313, India |
| 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 |
| Dr Ankita Sharma |
amity university |
Amity Institute of health allied sciences, Amity university noida, sector 125, Uttar Pradesh, 201313, India
Gautam Buddha Nagar
UTTAR PRADESH |
88263 95132
asharma39@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee, Amity Institute of health allied sciences, Amity university Uttar pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In person pilates with pelvic floor muscle training |
For eight weeks, there will be three sessions per week. Each session will last 60
minutes. Physiotherapist-led session in clinic setting will be done for in-person pilates and pelvic floor muscle training group. |
| Intervention |
Remote Pilates with Pelvic floor muscle training |
Remote Pilates and PFMT in Group A Sessions will be conducted under the supervision of a licensed physiotherapist and are conducted live online through Zoom or Google Meet and whats -app.
Each session lasts 60 minutes, and participants attend three sessions a week for eight weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Female participants aged 30 to 45 years
Persistent urinary leakage symptoms as seen by pre-screening Incontinence Questionnaire
Possess the cognitive ability to comprehend, follow, and execute the therapeutic
instructions effectively.
Leakage on the 3-h pad test of 1 to 2 g (mild) or 2 to10 g (moderate) as seen during in person screening
Must have access to a stable internet connection and a functional smart device
(smartphone, tablet, or computer) to participate in remote pilates sessions.
Demonstrate willingness to engage in the full eight-week intervention program, maintaining three structured sessions per week, along with scheduled follow-up evaluations.
Voluntarily provide informed written consent.
Capable of communicating in english language. |
|
| ExclusionCriteria |
| Details |
Pregnant or women in the early postpartum period (less than six months postpartum)
Women with pelvic organ prolapse (grade II or above), diagnosed by Gyanecologists
Individuals presenting with neurological impairments (e.g., stroke, multiple sclerosis, spinal cord injury) impacting voluntary bladder or pelvic floor control.
Cases diagnosed solely with urge urinary incontinence, lacking a stress or mixed component.
Concurrent participation in other pelvic health therapies, pharmacological treatments for urinary incontinence, or on oestrogen treatment for other conditions or any form of physiotherapy targeting pelvic function during the study period.
Individuals with uncontrolled systemic illnesses (cardiac, metabolic, respiratory) contraindicating moderate-intensity exercise participation.
Cognitive or psychological disorders (e.g., severe anxiety, major depressive disorder) that
may compromise adherence and participation in therapy sessions.
Reluctance or inability to fully commit to the study duration, intervention schedule, or follow-up assessments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in urinary leakage. |
Baseline and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life. |
Baseline and post intervention |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Urinary incontinence is a common yet often underreported condition among premenopausal females and it negatively affects daily activities emotional wellbeing and quality of life strengthening of pelvic floor muscles through structured exercise programs reflects positive outcomes in reducing urine leakage and improving confidence pilates based training enhances core strength postural support and pelvic floor engagement making it a suitable approach for rehabilitation with increasing accessibility to digital technology tele rehabilitation exercise programs provide an alternative to in person supervised sessions especially for women who are unable to attend clinic based therapy due to social work related or geographical barriers this comparative study aims to evaluate the effectiveness of remote Pilates and in person Pilates combined with pelvic floor muscle training in premenopausal females with urinary incontinence a total of seventy four participants will be selected based on eligibility criteria and will be divided into two groups both groups will receive a structured eight week program three sessions per week each lasting sixty minutes outcomes will be measured using one hour pad test Incontinence Quality of Life questionnaire Oxford stress and frequency scoring and core strength assessment tools pre and post intervention changes will be statistically analyzed to compare improvements in urinary leakage frequency core strength and quality of life the study is expected to determine whether tele Pilates can provide similar or better outcomes compared to traditional in person supervised sessions findings may support the use of remote therapy as an accessible cost effective and patient friendly model for pelvic floor rehabilitation |