| 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
|
|
|
Primary Sponsor
|
| Name |
Amity university |
| Address |
Amity university, sector -125, Noida, Uttar Pradesh,201313 |
| Type of Sponsor |
Research institution |
|
|
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 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
|
|
|
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.
|