| CTRI Number |
CTRI/2025/08/093789 [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
|
A study to see if home exercises like walking and training with free weights which were done without guidance of a therapist, can help people who have both less muscle and high body fat — to feel stronger, move better, and live healthier. |
|
Scientific Title of Study
|
Effects of unsupervised aerobic and resistance training on fat mass reduction, physical function and quality of life in patients with sarcopenic obesity - a randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Koushiki Kolay |
| Designation |
Masters of Physiotherapy |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
Nopany Institute of Healthcare Studies
2C, Nando Mullick Lane, Girish Park
Kolkata- 700006
West Bengal
India
Kolkata
WEST BENGAL
700006
India |
| Phone |
08159891608 |
| Fax |
|
| Email |
koushiki.kolay6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shabnam Agarwal |
| Designation |
Professor |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
Department of Physiotherapy
Nopany Institute of Healthcare Studies
2C, Nando Mullick Lane, Girish Park
Kolkata- 700006
West Bengal
India
Kolkata
WEST BENGAL
700006
India |
| Phone |
9830055645 |
| Fax |
|
| Email |
directornopany@nihs.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Shilpasree Saha |
| Designation |
Assistant professor |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
Department of Physiotherapy
Nopany Institute of Healthcare Studies
2C, Nando Mullick Lane, Girish Park
Kolkata- 700006
West Bengal
India
Kolkata
WEST BENGAL
700006
India |
| Phone |
8787528584 |
| Fax |
|
| Email |
shilpasree@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
2C, Nando Mullick Lane, Girish Park
Kolkata- 700006
West Bengal
India |
| 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 Koushiki Kolay |
Nopany Institute of Healthcare Studies |
Department of Physiotherapy
2C, Nando Mullick Lane, Girish Park
Kolkata- 700006
West Bengal
Kolkata
WEST BENGAL |
8159891608
koushiki.kolay6@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 |
Supervised Aerobic and Resistance training |
5 sessions /week for 8 weeks |
| Intervention |
Unsupervised Aerobic and Resistance training |
5 sessions /week, for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Low Skeletal Muscle Index, with less than 10.2 kg/m2 in men and less than 8.3 kg/m2 in females
2.Increased Percentage Body Fat: more than 29.7 percentage in men and more than 37.2 percentage in women. |
|
| ExclusionCriteria |
| Details |
1. Patients response as "YES" to any of the questions in PARQ & You Questionnaire
2. Non- ambulatory patients |
|
|
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 |
Skeletal Muscle Index
Percentage Body Fat
Waist Circumference
Hand Grip Strength |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physical functional capacity
Quality of Life |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/09/2025 |
| 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
|
Sarcopenic obesity, characterized by the coexistence of reduced muscle mass and increased fat mass, is an emerging health concern with significant implications for physical function, metabolic health, and quality of life in older adults. Its prevalence is steadily rising worldwide due to aging populations, sedentary lifestyles, and obesity epidemics. This dual burden not only increases the risk of disability but also limits independence and daily functioning.
Methodology: The present randomized clinical trial will evaluate the effects of unsupervised aerobic and resistance exercise on fat mass reduction, physical function, and quality of life in patients with sarcopenic obesity. Eligible participants will be recruited from physiotherapy clinics through screening based on diagnostic criteria for sarcopenic obesity, including assessment of body composition, strength, and functional capacity. After recruitment, participants will be randomly allocated into two intervention groups,with each group (n=20): Group A will be unsupervised group and Group B will be supervised group, both performing aerobic and resistance exercises. Both groups will be provided with structured, exercise protocols, to be performed for 5 times a week for 8 weeks.
Statistical analysis: The statistical analysis will be performed using SPSS software version 30.0. The primary analysis will be done using descriptive statistics to analyze demographic data. Pre ( baseline) and post ( 8 weeks) intervention data will be collected. Within-group changes will be evaluated using paired t-tests and between- group differences will be analyzed using independent t-tests. A p-value less than 0.05 will be considered statistically significant. |