| CTRI Number |
CTRI/2026/04/107925 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Checking the risk of muscle loss in women after menopause and comparing task based training and regular exercise to see which works better |
|
Scientific Title of Study
|
Screening Postmenopausal Women For Sarcopenia Risk:A Randomised Controlled Trial Comparing Functional Task Oriented Training Versus Conventional Treatment On Muscle Strength,Fatigue,Functional Outcomes And Biomarkers |
| 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 Jinal Porwal |
| Designation |
PhD Scholar |
| Affiliation |
Bharati Vidyapeeth School of Physiotherapy, Sangli |
| Address |
Bharati vidhyapeeth (Deemed to be university) school of physiotherapy, department of community rehabilitation, OPD no.18, Sangli
Sangli MAHARASHTRA 416414 India |
| Phone |
9353330601 |
| Fax |
|
| Email |
drjinalnaik@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sneha Katke |
| Designation |
Principal |
| Affiliation |
Bharati vidyapeeth school of physiotherapy |
| Address |
Bharati vidhyapeeth (Deemed to be university) school of physiotherapy, department of community rehabilitation, OPD no.18, Sangli
Sangli MAHARASHTRA 416414 India |
| Phone |
9158587070 |
| Fax |
|
| Email |
sneha.katke@bharatividyapeeth.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Jinal Naik |
| Designation |
Assistant professor |
| Affiliation |
Bharati vidyapeeth school of physiotherapy |
| Address |
Bharati vidhyapeeth (Deemed to be university) school of physiotherapy, department of community rehabilitation, OPD no.18, Sangli
Belgaum KARNATAKA 416414 India |
| Phone |
9353330601 |
| Fax |
|
| Email |
drjinalnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati vidhyapeeth Medical college and hospital, Sangli-Miraj Road,Wanleswadi, Sangli Maharastra, India- 416416 |
| NIL |
|
|
Primary Sponsor
|
| Name |
Bharati vidyapeeth school of physiotherapy |
| Address |
Sangli - Miraj Rd, Wanalesawadi, Vijaynagar, Sangli, Miraj, Maharashtra 416414 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Jinal Porwal |
Bharati vidhyapeeth school of physiotherapy |
Bharati vidhyapeeth (Deemed to be university) school of physiotherapy, department of community rehabilitation, OPD no.18, Sangli Sangli MAHARASHTRA |
9353330601
drjinalnaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee Bharati vidyapeeth deemed to be university medical college and hospital, Sangli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
postmenopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
coventional treatment for prevention of sarcopenia |
Group B in OPD using specialized equipment for strength training including resistance exercises using thera bands and dumbbells for 6 days per week |
| Intervention |
Functional task oriented training |
Group A – structured home-based exercises 6 days per week for 3 months including resistance, balance, endurance & circuit training With no specialized equipment |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Women aged 50–65 years who have experienced amenorrhea for at least 12 months, confirmed by blood tests showing low estrogen levels.
2. Pre-sarcopenia or risk of sarcopenia based on AWGS 2019 criteria (low muscle mass or strength without severe mobility loss) having a score of SARC-CalF more than or equal to 11.
3. Ambulatory, able to walk independently without assistive devices
4. Stable medical condition and not on anti-inflammatory or hormonal therapy in the past 6 months
5. Willing to provide informed consent and comply with intervention and follow-ups
|
|
| ExclusionCriteria |
| Details |
1- severe cardiopulmonary, renal, hepatic or neurological disorders affecting exercise participation
2- recent fractures or orthopedic surgery or severe arthritis limiting mobility
3- current hormone replacement therapy or long term corticosteroid use
4- active malignancy, autoimmune, or chronic inflammatory disease.
5-uncontrolled diabetes or hypertension.
6- participation in regular resistance training.
7- cognitive impairement or psychiatric illness limiting compliance |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Biomarkers- IL6 & CRP
Muscle Strength- Handheld dynamometer
Fatigue- Fatigue severity scale
Functional outcomes- ICF
|
Pre- baseline, Interim- 3 weeks and Post intervention at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Peak expiratory flow rate |
Pre- baseline, Interim- 3 weeks & Post intervention at 3 months |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
23/04/2026 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 study procedure will involve screening and recruiting postmenopausal women aged 50 to 65 years who are at risk of sarcopenia from Department of community physiotherapy, school of physiotherapy Sangli. After initial screening using standard criteria like the Asian Working Group for Sarcopenia guidelines and obtaining informed consent, participants will undergo baseline assessments including estrogen levels (estradiol) to confirm the post-menopausal status and other measures of muscle strength, fatigue, functional outcomes based on the ICF framework, inflammatory biomarkers, and peak expiratory flow rate. Participants will then be randomized into two groups: one receiving a 12-week Functional Task-Oriented Training program tailored to improve daily functional movements, and the other receiving conventional physiotherapy treatment. Throughout the intervention, adherence and safety will be closely monitored, with adverse events managed promptly. Post-intervention assessments identical to the baseline will be conducted by blinded evaluators to determine changes in the outcome measures. Data will be securely managed and analysed to compare the effect of both interventions on enhancing muscle strength, reducing fatigue, improving function, and modulating biomarkers, ensuring a comprehensive understanding of the intervention’s effectiveness in this population. |