| CTRI Number |
CTRI/2026/01/100674 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying the effectiveness of Swiss Ball in addition to Conventional Physiotherapy in Post Menopausal Women |
|
Scientific Title of Study
|
Effectiveness of Swiss Ball and Conventional Exercises on Body Composition and Physical Performance in Post-Menopausal Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerna thosar |
| Designation |
Student(Intern) |
| Affiliation |
DR APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences |
| Address |
DR APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmednagar Maharashtra
Ahmednagar
MAHARASHTRA
413736
India
Flat no.18 natraj residency teen hatti chowk,dhankwadi Pune- 411043
Pune
MAHARASHTRA
413736
India |
| Phone |
8275034001 |
| Fax |
|
| Email |
prernathosar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prerna thosar |
| Designation |
Undergraduate |
| Affiliation |
DR APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences |
| Address |
DR APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmednagar Maharashtra
Ahmednagar
MAHARASHTRA
413736
India
Flat no. 18 c wing teen hatti chowk, dhankawadi,Pune 411043
Pune
MAHARASHTRA
413736
India |
| Phone |
8275034001 |
| Fax |
|
| Email |
prernathosar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Hande |
| Designation |
HOD |
| Affiliation |
DR APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences |
| Address |
Pravara Institute of Medical Sciences Loni Tal Rahata Dist Ahmednagar Maharashtra
Ahmednagar
MAHARASHTRA
413736
India
DR APJ Abdul Kalam College of Physiotherapy, Department of community physiotherapy, 4th floor-404
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7743841483 |
| Fax |
|
| Email |
deepali.hande@pmtpims.org |
|
|
Source of Monetary or Material Support
|
| Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni, Ahmednagar, 413736 |
|
|
Primary Sponsor
|
| Name |
Prerna Thosar |
| Address |
Pravara institute of medical sciences, Rahata, loni, Ahemadnagar, Maharshtra 413736 |
| 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 |
| Prerna thosar |
Dr. APJ Abdul Kalam College of physiotherapy |
Dr. APJ Abdul Kalam College of physiotherapy; OPD of Community Physiotherapy-404
Ahmadnagar
MAHARASHTRA |
07743841483
prernathosar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post menopausal womens |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy exercises on post menopausal womens |
Conventional exercises were given for 6 days a week for 4 weeks. |
| Intervention |
Swiss ball exercises in post menopausal women |
Exercises with Swiss ball were given 6 days a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 50-70 years who have achieved menopause.
2. Women with BMI between 18.5 and 35kg/m².
3. Women with sedentary lifestyle.
4. women with good cognitive function and the ability to follow exercise instructions independently.
|
|
| ExclusionCriteria |
| Details |
1. Women with osteoporosis-related fragility fractures or severe musculoskeletal conditions affecting mobility.
2. Women with neurological disorders (e.g., Parkinson’s disease, stroke, multiple sclerosis).
3. Participants with Uncontrolled hypertension, cardiovascular diseases, or diabetes that contraindicate exercise.
4. Women undergoing hormone replacement therapy (HRT) that could significantly influence body composition outcomes.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Body Mass Index (BMI).
2. Body fat percentage (Omron Body Fat Analyzer H375).
3. Waist-Hip Ratio (WHR).
4. Short Physical Performance Battery.
|
Baseline (pre-intervention)
After 4 weeks (post-intervention)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Menopause-Specific Quality of Life (MENQOL) Questionnaire.
|
Baseline (pre-intervention)
After 4 weeks (post-intervention)
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
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 permanent
cessation of menstruation is known as menopause. After a year without
menstruation, the diagnosis is established retroactively. Post-menopause, the secretion of female hormones
changes, causing excessive fat accumulation in the body this in return
increases the CVS risks.
On average, women aged between 45 and 55 gain
around half a kilo per year. As women get older, they lose muscle mass, which
slows their metabolism and
causes weight gain. Weight gain is a symptom of menopause
experienced by 60%–70% of midlife women.
Menopause is associated
with hormonal changes that contribute to increased fat accumulation, decreased
lean muscle mass, and reduced bone density, leading to adverse changes in body
composition and physical performance. These
alterations negatively impact body composition, musculoskeletal integrity,
overall physical performance, and quality of life increasing the risk of
sarcopenia, osteoporosis, cardiovascular diseases, and metabolic disorders.
Exercise interventions
play a crucial role in effective intervention to mitigate these adverse
changes, enhancing muscle strength, endurance, and metabolic health. While
conventional exercise programs focusing on resistance and aerobic training have
demonstrated benefits in improving physical fitness and musculoskeletal
function, there is limited evidence regarding the efficacy of Swiss ball
exercises in this population. Swiss ball training, known for engaging core
muscles, enhancing neuromuscular control, and promoting dynamic balance, may
provide additional functional benefits beyond conventional exercise approaches
This study aims to understand the effect of Swiss ball exercises compared to conventional physiotherapy in post menopausal women’s body composition. Swiss ball exercises and conventional physiotherapy will be given 6 days a week for 4 weeks and outcomes will be measured pre and post interventions. |