| CTRI Number |
CTRI/2025/08/093731 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| 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
|
Strength Training and Protein Diet to Improve Muscle in People with Early Muscle Loss |
|
Scientific Title of Study
|
Effect of Resistance Training and Modified Protein Intake on Muscle Mass In PRE-SARCOPENIC Individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehasish Laha |
| Designation |
Masters of Physiotherapy |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
Nopany Institute of Healthcare Studies
2C, Nando Mullick Lane, Girish Park
Kolkata-700006
Westbengal, India
Kolkata
WEST BENGAL
700006
India |
| Phone |
8167276236 |
| Fax |
|
| Email |
snehasishlaha2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanusree Basak |
| Designation |
MPT(Musculoskeletal & Sports), Associate Professor |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
Department of Physiotherapy Nopany Institute of Healthcare Studies
2C, Nando Mullick Lane, Girish Park
Kolkata-700006
Westbengal, India
Kolkata
WEST BENGAL
700006
India |
| Phone |
9830601041 |
| Fax |
|
| Email |
coordinatormpt@nihs.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Tapas Kumar Pal |
| Designation |
MPT(Musculoskeletal & Sports), Associate Professor |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
Department of Physiotherapy Nopany Institute of Healthcare Studies
2C, Nando Mullick Lane, Girish Park
Kolkata-700006
Westbengal, India
Kolkata
WEST BENGAL
700006
India |
| Phone |
9804257395 |
| Fax |
|
| Email |
tapas@nihs.ac.in |
|
|
Source of Monetary or Material Support
|
| Nopany Institute of Healthcare Studies, Kolkata, West Bengal, India, pin-700006 |
|
|
Primary Sponsor
|
| Name |
Nopany Institute of Healthcare Studies |
| Address |
Nopany Institute of Healthcare Studies, Kolkata, West Bengal, India, pin-700006 |
| 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 |
| Snehasish Laha |
Nopany Institute of Healthcare Studies |
Nopany Institute of Healthcare Studies, Kolkata, West Bengal, India, pin-700006
Kolkata
WEST BENGAL |
8167276236
snehasishlaha2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nopany Institute of Healthcare Studies Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Resistance Training |
3 sessions/week for 10 weeks |
| Intervention |
Resistance Training and Modified Protein Intake |
For exercise: 3 sessions/week for 10 weeks
For diet: followed every day |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Calf circumference: less than 34 cm for males, less than 33 cm for females
Body Mass Index: less than 24kg/m2 |
|
| ExclusionCriteria |
| Details |
Non-ambulatory
Non-cooperative patients
Protein allergy
Cognitive impairments
Neurological disorders (like stroke, Alzheimer’s disease, etc.)
• Cardiovascular diseases or uncontrolled hypertension
• Previous surgery on lower limbs affecting gait
• Severe arthritis
• Persons with fever or any kind of systemic infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Muscle Mass
Skeletal Muscle Mass |
10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life assessed by Sarqol questionnaire |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/08/2026 |
| 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)
|
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
|
Sarcopenia,
a progressive age-related condition marked by the decline of muscle mass,
strength, and function, often begins after the age of 50. While resistance
training is known to effectively increase muscle mass (CC), insufficient
protein intake may accelerate the onset. This study aimed to evaluate the
combined and individual effects of resistance training and modified plant-based
protein intake on muscle mass in individuals with pre-sarcopenia. A total of 40
participants were initially recruited through convenience sampling, with 12
dropping out, leaving 28 individuals divided into two groups. Group A (n=15)
engaged in elastic band resistance training along with a prescribed plant-based
protein diet, while Group B (n=13) performed the same exercise regimen without
dietary modification. Both groups trained for 45 minutes, three times a week,
over 10 weeks. Post-intervention analysis revealed significant improvements in CC,
SMM and QOL within both groups (p<0.05). However, no significant differences
were found between the two groups. The study concludes that Resistance Training and the modified protein group
showed greater improvements in mean values as compared to Resistance Training alone;
however, neither group outperformed the other. |