| CTRI Number |
CTRI/2026/02/104076 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of exercise on body fat and symptoms in Rheumatoid Arthritis patients |
|
Scientific Title of Study
|
A Longitudinal Study on Adipose Tissue Distribution, Its Changes Following a Structured Exercise Program and Its Correlation with Disease Activity in Rheumatoid Arthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanika Markan |
| Designation |
Ph.D. Scholar |
| Affiliation |
Noida International University |
| Address |
Department of Physiotherapy,Room 305,Noida International University,Plot 1, Yamuna Expy, Sector 17A, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
919891893648 |
| Fax |
|
| Email |
kanikamarkan@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ranjana Singh |
| Designation |
Professor & HOD, Community Medicine |
| Affiliation |
Noida International University |
| Address |
Noida International Institute of Medical Sciences,Noida International University,Plot 1, Yamuna Expy, Sector 17A, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9654873085 |
| Fax |
|
| Email |
sranjana@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanika Markan |
| Designation |
Ph.D. Scholar |
| Affiliation |
Noida International University |
| Address |
Department of Physiotherapy,Room 305,Noida International University,Plot 1, Yamuna Expy, Sector 17A, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
919891893648 |
| Fax |
|
| Email |
kanikamarkan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Medanta- The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122018 |
|
|
Primary Sponsor
|
| Name |
Medanta - The Medicity, Gurugram |
| Address |
Medanta- The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajiva Gupta |
Medanta The Medicity, Gurugram |
Medanta- The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122018
Gurgaon
HARYANA |
98109 04592
rajiva.gupta@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Baseline data (VAT/SAT distribution) |
Participants in the comparator arm will receive standard medical management for rheumatoid arthritis (RA) as prescribed by their treating rheumatologist, in accordance with routine clinical practice. This includes stable doses of disease-modifying antirheumatic drugs (DMARDs), biologic agents, corticosteroids, and/or non-steroidal anti-inflammatory drugs (NSAIDs), as clinically indicated.
The comparator group will not receive the structured aerobic and resistance exercise program provided to the intervention group. They will continue their usual daily physical activities without any supervised or protocol-driven exercise training.
Both the intervention and comparator groups will undergo identical assessments at baseline and at 6-month follow-up, including:
Disease activity assessment (DAS28-ESR / DAS28-CRP)
Body composition analysis using DXA (VAT and SAT)
Handgrip strength measurement
Functional disability assessment (HAQ-DI)
Laboratory evaluation of inflammatory markers (ESR, CRP) |
| Intervention |
Structured, Supervised Exercise Program |
Aerobic Training: Outdoor walking or stationary cycling for 30 minutes per session, 3 times per week.
Resistance Training: Exercises focused on major muscle groups (Quadriceps, Gluteal, Hamstrings, Deltoids, Biceps, Triceps, Abdominal, and Hand muscles) using TheraBand and Thera putty. This is scheduled for 2 sessions per week.
Standard Care: All participants in the intervention group also continue to receive standard RA care as prescribed by their treating rheumatologist.6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age between eighteen and fifty years, either gender
Diagnosed with rheumatoid arthritis according to the two thousand ten ACR EULAR classification criteria
Disease duration between six months and five years
Active disease with DAS twenty eight ESR greater than three point one
On stable standard medical treatment for rheumatoid arthritis
Willing to undergo dual energy X ray absorptiometry assessment
Willing to participate in a six month structured aerobic and resistance exercise program
Able to comply with study procedures and follow up assessments
Written |
|
| ExclusionCriteria |
| Details |
Presence of any other autoimmune or systemic inflammatory disorder
Uncontrolled medical conditions such as cardiovascular disease diabetes hypertension dyslipidemia or hypothyroidism
Current or past history of malignancy
Pregnant or lactating women
Contraindication to dual energy X ray absorptiometry assessment
Body mass index more than thirty five
Any musculoskeletal neurological or cardiopulmonary condition limiting safe participation in exercise
Inability or unwillingness to comply with study protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visceral adipose tissue
Subcutaneous adipose tissue
Rheumatoid arthritis disease activity measured by DAS twenty eight ESR |
at baseline, 4 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Handgrip strength
Functional disability assessed by health assessment questionnaire disability index
Systemic inflammatory markers erythrocyte sedimentation rate & C reactive protein
Body composition parameters measured by dual energy X ray absorptiometry
Correlation between adipose tissue distribution & disease activity |
at baseline, 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
09/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a longitudinal investigation designed to evaluate adipose tissue distribution and its changes following a structured exercise program in patients with rheumatoid arthritis. The study aims to assess the relationship between visceral and subcutaneous adipose tissue and disease activity, inflammation, and functional outcomes over a six month period. Participants will receive standard medical care along with a supervised aerobic and resistance exercise program. Body composition will be assessed using dual energy X ray absorptiometry, while disease activity functional status muscle strength and inflammatory markers will be evaluated at baseline and at six months. The findings of this study may help clarify the role of exercise induced changes in adipose tissue in improving disease activity and overall functional status in rheumatoid arthritis patients. |