CTRI

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CTRI Number

CTRI/2025/07/092003 [Registered on: 30/07/2025] Trial Registered Prospectively

Last Modified On:

15/09/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group Trial

Public Title of Study

How Core and Pelvic Floor Exercises Help Women Breathe Better After Menopause

Scientific Title of Study

Comparative study of pelvic floor muscles versus core muscles strengthening exercises on respiratory muscle strength and pulmonary function in post menopausal females

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr. Mayura Deshmukh.
Designation	PhD
Affiliation	Dr. D.Y Patil College Of Physiotherapy.
Address	310,Cardio-Respiratory Department, Dr.D.Y Patil College of Physiotherapy Sant Tukaram Nagar Pimpri, Pune-411018. 310,Cardio-Respiratory Department, Dr.D.Y Patil College of Physiotherapy Sant Tukaram Nagar Pimpri, Pune-411018. Pune MAHARASHTRA 411018 India
Phone	8149376929
Fax
Email	mayuradeshmukh04@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Mayura Deshmukh.
Designation	PhD
Affiliation	Dr. D.Y Patil College Of Physiotherapy.
Address	310 Cardio-Respiratory Department Dr. D.Y Patil College Of Physiotherapy, Sant Tukaram Nagar Pimpri, Pune-411018. 310, Cardio-Respiratory Department Dr. D.Y Patil College Of Physiotherapy, Sant Tukaram Nagar Pimpri, Pune-411018. Pune MAHARASHTRA 411018 India
Phone	8149376929
Fax
Email	mayuradeshmukh04@gmail.com

Details of Contact Person
Public Query

Name	Vrunda Sonawane
Designation	Post Graduate student
Affiliation	Dr. D.Y Patil College Of Physiotherapy.
Address	310,Cardio-Respiratory Department. Dr. D.Y Patil College Of Physiotherapy, Sant Tukaram Nagar Pimpri, Pune-411018. 310,Cardio-Respiratory Department. Dr. D.Y Patil College Of Physiotherapy, Sant Tukaram Nagar Pimpri, Pune-411018. Pune MAHARASHTRA 411018 India
Phone	9028325182
Fax
Email	vrundasonawane0@gmail.com

Source of Monetary or Material Support

Dr. D.Y Patil Medical College, Hospital and Research centre. Sant Tukaram Nagar Pimpri Pune-411018

Primary Sponsor

Name	Vrunda Sonawane
Address	Dr. D. Y Patil College Of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune,411018.
Type of Sponsor	Research institution

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 Mayura Deshmukh	Dr. D.Y Patil College Of Physiotherapy	Cardiorespiartory Department Dr. D.Y Patil College Of Physiotherapy, Sant Tukaram Nagar Pimpri, Pune-411018. Sant Tukaram Nagar Pimpri, Pune-411018. Pune MAHARASHTRA	8149376929 mayuradeshmukh04@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Post Menopausal Females

Intervention / Comparator Agent

Type	Name	Details
Intervention	Group A - Pelvic Floor Muscle Strengthening exercises.	Group A: Participants will undergo pre-assessment including: Pelvic Floor Muscle (PFM) strength – measured using the Modified Oxford Scale Pulmonary Function Test (PFT) – assessing Forced Vital Capacity (FVC) Diaphragmatic strength – evaluated using Maximal Respiratory Pressure (RPM) After Pre-Assessment The group will under go plevic floor muscle exercise for 4 weeks, than again the participants will undergo the same post assessment as Pre-Assessment.
Comparator Agent	Group B - Core Muscle Strengthening exercises.	Group B: Participants will undergo pre-assessment including: Abdominal Muscle Strength – assessed via Manual Muscle Testing (MMT) Pulmonary Function Test (PFT) – assessing Forced Vital Capacity (FVC) Diaphragmatic strength – evaluated using Maximal Respiratory Pressure (RPM) after all this Core Muscle Strengthening exercises will be given and than Post Assessment will be taken which will be same as Pre-assessment

Inclusion Criteria

Age From	45.00 Day(s)
Age To	55.00 Year(s)
Gender	Female
Details	Post Menopausal Females. Females in the age group of 45 to 55 years of age. Females with normal physiological menopause. Baseline : after 1 Year of Menopause.

ExclusionCriteria

Details

Female with any cardiovascular disease.
Female having low back pain
Surgical implants in the reproductive tract such as Copper-T
Any surgical history of the reproductive system such as Total Laparoscopic Hysterectomy (TLH) or Bilateral salpingo-oophorectomy (BSO).
Recent abdominal or thoracic surgeries
Cardio respiratory disease like COPD, asthma, Tuberculosis, angina.
Any neurological condition like spinal cord injury, multiple sclerosis, peripheral nerve injury, Hernia.

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
1) PFT 2) RPM	1) PFT 2) RPM 4 weeks

Secondary Outcome

Outcome	TimePoints
Modified Oxford Scale for 1)Pelvic Floor Muscle. 2)MMT for abdominal muscles.	4 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
Modification(s)

N/A

Date of First Enrollment (India)

20/08/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

20/08/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

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

Introduction :

Menopause is a natural biological transition marked by hormonal changes, particularly a decline in estrogen, leading to various systemic effects including decreased pelvic floor and core muscle strength, and reduced pulmonary function. These changes may impair respiratory muscle strength and lung capacity. Strengthening pelvic floor and core muscles could potentially enhance respiratory outcomes in postmenopausal women.

Aim: To evaluate the effect of pelvic floor and core muscle strengthening exercises on respiratory muscle strength and pulmonary function in postmenopausal females.

Objectives:

To assess the effect of pelvic floor muscle strengthening on respiratory strength and pulmonary function.
To assess the effect of core muscle strengthening on respiratory strength and pulmonary function.
To compare pre- and post-intervention changes in both groups using RPM and PFT.

Methodology (Brief):Design: Experimental Study, Sample Size: 60 postmenopausal females (aged 45–55), Sampling: Convenient Sampling, Setting: Dr. D. Y. Patil Medical College, Pune ,Duration: 2024–2026, Groups: Group A: Pelvic floor exercises, Group B: Core (abdominal) exercises. Outcome Tools: Modified Oxford Scale, MMT, RPM, PFT. Inclusion/Exclusion Criteria: Women 1+ year post-menopause; excludes those with cardiovascular, neurological, respiratory, or recent surgical history

Procedure:

After ethical approval and consent, 60 participants will be divided into two groups. Group A will perform Kegel’s exercises for pelvic floor strengthening. Group B will perform abdominal strengthening exercises. Each group will undergo pre- and post-assessment over a 4-week intervention using Oxford Scale, MMT, RPM, and PFT to evaluate improvements in respiratory strength and function.