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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  
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 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  
Status 
Not Applicable 
 
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.

 
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