FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105144 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 01/03/2026
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   Simple exercise of core to improve balance and reduce falls in women after menopause 
Scientific Title of Study   Effect of core strengthening exercises on balance and fall 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  Nidhi Aggarwal 
Designation  Pg student 
Affiliation  Amity university of health allied sciences 
Address  Room Number-Lg23 Ground floor F1 block department of physiotherapy Amity University Sector 125 Noida

Gautam Buddha Nagar
UTTAR PRADESH
201313
India 
Phone  9588396148  
Fax  00000  
Email  nidhiaggarwal0301@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nidhi Sharma 
Designation  Assistant Professor 
Affiliation  Amity university of health allied sciences 
Address  Room number Lg23 Block F1 Lower Ground Department of Physiotherapy Amity University Sector 125 Noida India

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9588396148  
Fax  00000  
Email  nsharma30@amityedu  
 
Details of Contact Person
Public Query
 
Name  Dr Vidhi Jain 
Designation  Senior Physiotherapist 
Affiliation  Vinayak Hospital 
Address  Department Of Physiotherapy Vinayak Hospital Uttar Pradesh 201301 India

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9582437144  
Fax  00000  
Email  vidhij.physio@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Amity university  
Address  Amity university, sector -125, Noida, Uttar Pradesh,201313 
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 Vidhi Jain  Vinayak hospital   H8CH+C52, Atta Market, Pocket E, Sector 27, Noida, Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH 
9582437144

vidhij.physio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional NTCC committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exercise protocol for Core strengthening   Core strengthening protocol Warm up( Spot marching Arm swings Cat-cow stretch Shoulder rolls Pelvic tilts) Week1-2(Supine abdominal bracing Glute bridge Supine march Dead bug Week 3-4(bird dog Heel slides Modified side plank Seated trunk rotation)  
Comparator Agent  Generalised physiotherapy protocol   Week 1(warm up walk Heel Raises Toe raises Marching in place Side stepping Standing hip Abduction ) Week 2(brisk walking Heel-to-toe walk Sit to stand Step ups Standing hip extension Week 3 fast brisk walk Semi-tandem to tandem stance Single leg stance Lateral step ups Forward lunges) Week4 fast walking Tandem waking Sit to stand Steps ups Single leg stance 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Post menopausal women
BBS score- 40
Fall Efficacy Scale score- 16-27
McGill Torso test- 30-60 sec
Able to walk independntly 
 
ExclusionCriteria 
Details  History of recent fractures
History of surgeries of lower limb or spine since 6 months
Any balance or vestibular disorders
Severe cognitive impairment or psychiatric illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
berg balance scale
y balance test
time up and go test
fall efficacy scale
McGill torso test
pain catstrophizing scale
tampa scale of kinesiophpbia
 
day zero at the baseline and at the end of 4th week
 
 
Secondary Outcome  
Outcome  TimePoints 
Pain catastrophizing scale
Tampa scale of kinesiophobia 
Day zero at the baseline and at the end of 4th week 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   20/03/2026 
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="1"
Days="3" 
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  

This study aims to evaluate the effect of core strengthening exercises on balance and fall risk in post-menopausal women. Post-menopausal hormonal changes lead to reduced muscle strength, impaired postural control, increased pain sensitivity, and higher fall risk. Core strengthening improves trunk stability and balance, while PNE addresses maladaptive pain beliefs, fear of movement, and pain catastrophizing, thereby enhancing exercise participation and movement confidence. This community-based, single-blinded, randomized controlled trial will include post-menopausal women allocated into two groups: an intervention group receiving  with a structured core strengthening program and a control group receiving conventional physiotherapy exercises. Interventions will be conducted over four weeks. Balance, fall risk, core strength, pain catastrophizing, and fear of movement will be assessed using standardized outcome measures including Berg Balance Scale, Y-Balance Test, Timed Up and Go Test, Fall Efficacy Scale, McGill Torso Test, Pain Catastrophizing Scale, and Tampa Scale of Kinesiophobia. The study aims to determine whether core strengthening provides superior improvement in balance and fall prevention compared to conventional physiotherapy alone.


 
Close