| CTRI Number |
CTRI/2026/04/107522 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of a Multimodal Exercise Program for Improving Muscle Strength, Cognitive Function, and Sexual Health in Women with Surgical Menopause. |
|
Scientific Title of Study
|
Development and validation of multimodal exercise regime for muscular strength, cognitive function and sexual health matrix in surgical menopausal women A Delphi 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 |
Neha Rishikesh Javkar |
| Designation |
Post Graduate |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Advanced Physiotherapy Centre Department Of Community Based
Physiotherapy Physiotherapy room no:14 Sagar floor Dr Prabhakar
Kore Hospital and MRC Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8850020558 |
| Fax |
|
| Email |
nehajavkar2312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Advanced Physiotherapy centre Department of Orthopaedic
Physiotherapy Physiotherapy room no:18 Sagar floor Dr Prabhakar
Kore Hospital and MRC Belgaum Karnataka 590010
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalaxmi Kanabur |
| Designation |
Assistant Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Advanced Physiotherapy centre Department of Community Based
Physiotherapy Physiotherapy room no:14 Sagar floor Dr Prabhakar
Kore Hospital and MRC Belgaum Karnataka 590010
Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
8867480565 |
| Fax |
|
| Email |
vijayalaxmikanabur@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| Advanced Physiotherapy Centre Department Of Community Based Physiotherapy Physiotherapy
room no:14 Sagar floor Dr Prabhakar Kore Hospital and MRC Belgaum Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Neha Javkar |
| Address |
Advanced Physiotherapy Centre Department Of Community Based
Physiotherapy Physiotherapy room no:14 Sagar floor Dr Prabhakar
Kore Hospital and MRC Belgaum Karnataka 590010 |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 |
| Neha Javkar |
KLE DR PRABHAKAR KORE HOSPITAL AND MRC |
Advanced
Physiotherapy Centre,
room no. 39,Sagar
Floor,KLE
Dr.Prabhakar Kore
Hospital and
MRC,Nehru
Nagar,Belagavi
Belgaum
KARNATAKA |
8850020558
nehajavkar2312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICAL COMMIITTEE KLE INSTITUTEU OF PHYSIOTHERAPY,BELAGAVI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mutimodal Exercise regime |
Participants will undergo a
tailor-made multimodal
exercise program including
strength training, pelvic floor
exercises and cognitive tasks.
The exercise protocol will be
individualized according to
participant capacity and will be
supervised during the
intervention period of 4 weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 30-45 years.Surgical menopause (Hysterectomy with
or without Oophorectomy).1 month post-surgery.Experiencing
sexual dysfunction or related symptoms.Willing to perform
exercises |
|
| ExclusionCriteria |
| Details |
Recent pelvic or abdominal surgery within 3 months.Recent
pregnancy or breastfeeding.Severe cognitive impairment.Severe
musculoskeletal or neurological conditions.Medical conditions
contraindicating exercise (uncontrolled hypertension,recent MI). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Thirty-Second Arm Curl Test,Thirty-Second
Chair Stand Test,Montreal Cognitive
Assessment (MoCA),Female Sexual Function
Index (FSFI) |
0 weeks,4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
06/04/2026 |
| 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="6"
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
|
An initial multimodal exercise regime for women with surgical menopause will be developed through an extensive literature review. To establish content validity, a Delphi consensus process will be conducted with experts in women’s health physiotherapy. Experts having at least five years of academic or clinical experience will be invited to participate.
The developed exercise protocol will be shared with the expert panel along with a structured validation form. Experts will be asked to evaluate each component of the protocol for relevance, clarity, simplicity, and comprehensiveness using a 4-point Likert scale. Feedback and suggestions from the experts will also be collected.
Content validity will be calculated using the Item Content Validity Index (I-CVI) and Scale Content Validity Index (S-CVI). Items not meeting acceptable validity criteria will be revised based on expert recommendations, and subsequent Delphi rounds will be conducted until consensus is achieved.
After finalizing the validated multimodal exercise regime, a pilot feasibility assessment will be conducted among a small group of women with surgical menopause to evaluate feasibility, adherence, and acceptability. All collected data will be compiled and verified for completeness before statistical analysis. |