| CTRI Number |
CTRI/2026/03/105228 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Exercise on Inflammation in Rheumatoid Arthritis Patients |
|
Scientific Title of Study
|
Effect of Exercise Program on Inflammatory Markers in Patients with 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 |
Sushma Singh Chauhan |
| Designation |
PhD Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 1, Ground Floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala
HARYANA
133207
India |
| Phone |
7607756700 |
| Fax |
|
| Email |
sushmachauhan101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushma Singh Chauhan |
| Designation |
PhD Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 1, Ground Floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala
HARYANA
133207
India |
| Phone |
7607756700 |
| Fax |
|
| Email |
sushmachauhan101@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Aggarwal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Room No. 1, 1st Floor, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana
Ambala
HARYANA
133207
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, Pin Code: 133207, Country: India |
|
|
Primary Sponsor
|
| Name |
Sushma Singh Chauhan |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sushma Singh Chauhan |
MMIPR Physiotherapy OPD |
Ground Floor, MMIPR,
Maharishi Markandeshwar
Deemed to Be university,
Mullana, Ambala.
Ambala
HARYANA
Ambala
HARYANA |
7607756700
sushmachauhan101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Institute of Medical Sciences & Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care with Attention Control |
Standard rheumatological care with stable DMARD therapy. Includes one scheduled phone call at week 4 and educational materials regarding RA management. No structured exercise program provided. |
| Intervention |
Structured Supervised Exercise Program |
8 weeks supervised program, 3 sessions per week, 60 minutes per session. Includes 10 min warm up, 20 min aerobic exercise on treadmill at 65 to 80 percent max heart rate, 20 min resistance training with 1 to 3 kg dumbbells, and 10 min cool down. Supervised by qualified physiotherapist. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed Diagnosis of Rheumatoid Arthritis as per 2010 ACR EULAR classification criteria. 2. Disease duration of more than 6 months. 3. Stable DMARD therapy for at least 3 months prior to enrollment. 4. DAS28 score between 2.6 and 5.1 indicating low to moderate disease activity. 5. Baseline CRP greater than or equal to 3.0 mg per L or ESR greater than or equal to 20 mm per hr for men and 30 mm per hr for women. 6. Ability to walk independently without assistive devices. 7. Medical clearance for moderate intensity exercise. |
|
| ExclusionCriteria |
| Details |
1. High disease activity with DAS28 greater than 5.1 2. Corticosteroid use greater than 10 mg per day. 3. Participation in any structured exercise program within the last 6 months. 4. Uncontrolled hypertension, recent myocardial infarction, or unstable angina. 5. Severe orthopedic limitations or joint surgery within last 6 months. 6. Other inflammatory conditions like SLE or psoriatic arthritis. 7. Active malignancy or cancer treatment within 5 years. 8. Pregnancy or breastfeeding. 9. Significant cognitive impairment. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in serum C-reactive Protein (CRP) levels, Erythrocyte Sedimentation Rate (ESR) and Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies |
Baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disease Activity Score-28 (DAS28) |
Baseline, 4 weeks, and 8 weeks |
| Visual Analog Scale (VAS) for Pain |
Baseline, 4 weeks, and 8 weeks |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) |
Baseline, 4 weeks, and 8 weeks |
| Rheumatoid Arthritis Quality of Life (RAQOL) |
Baseline and 8 weeks |
| 6-Minute Walk Test (6MWT) |
Baseline and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
02/03/2026 |
| 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="2"
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
|
Rheumatoid arthritis is a chronic autoimmune inflammatory disease characterized by joint destruction and reduced quality of life. This randomized controlled trial aims to evaluate the effect of a structured exercise program on inflammatory markers in patients with Rheumatoid Arthritis. The study will recruit adult patients aged 40 to 65 years with established Rheumatoid Arthritis. Participants will be randomly assigned to two groups. The Exercise Group will undergo an 8 week supervised exercise program, three times a week. The Control Group will receive standard rheumatological care. The primary objective is to assess changes in inflammatory markers including C reactive protein, Erythrocyte Sedimentation Rate and Anti cyclic citrullinated peptide antibodies. Secondary objectives include assessment of disease activity, functional capacity, pain and quality of life. The study seeks to provide evidence for exercise as a non pharmacological intervention for reducing inflammation in Rheumatoid Arthritis. |