An experiment involving people with Rheumatoid arthritis (joint pain illness) to see the changes of illness level, involuntary action of heart and blood test to measure immune (protective) response by giving yoga

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2017
INTERVENTION: Intervention1: yoga therapy: Study group will undergo yoga therapy for 12 weeks (30 minutes, 3 times/week). Yoga therapy will be administered in the Department of ACYTER(Advanced Centre for Yoga Therapy Education and Research) by yoga instructors. Counselling will be given to control group. Both study group and control group will continue the standard medical treatment/drugs as prescribed by Department of Immunology. The attendance will be maintained for Yoga therapy sessions, regularity of home practice will be monitored by regular phone contact. (The schedule of Yoga therapy,Handouts, Video CD which contains the instructions of procedures will be given to the patients). YOGA THERAPY SCHEDULE 1. warming up : 2 minutes 2. Sukshmavyayama : 9 minutes a. Purna‐bhuja‐ sakti‐vikasaka(strengthening the arms) : 2 minutes b. Mani‐bandha‐ sakti‐vikasaka(strengthening the wrists) : 2 minutes c. Kara‐tala‐ sakti‐vikasaka(strengthening the palms) : 2 minutes d. Janu‐ sakti‐vikasaka(strengthening the knees) : 1 minute e. Gulpha‐pada‐prstha‐pada‐tala‐ sakti‐vikasaka (Developing the strength of the ankles and the feet) : 2 minutes 3. Yogasanas : 8 minutes Tadasana : 30 seconds Katichakrasana : 30 seconds Konasana : 30 seconds UrdhwaHastottanasana : 30 seconds Pavanamuktasana : 30 seconds Bhujangasana : 30 seconds Shavasana : 5 minutes 4. Pranayama : 6 minutes Nadishodhana Pranayama Chandrabhedi Pranayama Bhramari 5. Dhyana (meditation) : 5 minutes Total duration : 30 minutes Control Intervention1: Standard medical treatment for Rheumatoid arthritis: All patients with rheumatoid arthritis (RA) attending the OP or IP services of the Department of Immunology after thorough clinical and laboratory investigations, they will receive methotrexate (unless contraindicated) as initial DMARD (Disease‐Modifying Antirheuma CONDITION: patients of Rheumatoid arthritis PRIMARY OUTCOME: 1.Disease activity scale‐28 ; ; 2.Biochemical & Immunological parameters ; i) Inflammatory markers ; 1) ESR ; 2) IL‐6 ; 3) IL‐1 ; 4) TNF‐α ; ii) Oxidative stress markers ; 1) Serum malondialdehyde ; 2) Total antioxidant status ; iii) adipokines â?? adiponectin,leptin ; iv) serum cortisol (8.00 AM) ; 3. Cardiac autonomic function assessed by short term Heart Rate Variability. ; ; 4. BRS(Baroreflex sensitivity) ; ‐‐‐‐‐‐Timepoint: baseline and 12 weeks SECONDARY OUTCOME: Quality of life by Health Assessment Questionnaire‐‐‐‐‐‐Timepoint: baseline and 12 weeks INCLUSION CRITERIA: 1. Both genders between 18 and 60 years of age. 2. Newly onset Rheumatoid arthritis patients having disease duration less than 1 year with diagnosis of RA according to the 2010 ACR/EULAR criteria. 3. Rheumatoid arthritis patients partially responding to methotrexate therapy. Details All patients with rheumatoid arthritis (RA) attending the OP or IP services of the Department of Immunology after thorough clinical and laboratory investigations, they will receive methotrexate (unless contraindicated) as initial DMARD (Disease‐Modifying Antirheumatic Drugs ) therapy 10 mg per week, escalated @ 5 mg / week, every 2 weeks up to a maximum of 25 mg per week or maximum tolerated dose whichever is less at the end of 6 weeks. Patients will receive NSAlDs (Diclofenac 50 mg twice a day and SOS basis for control of pain). Treatment response will be assessed using EULAR response criteria at the end of three months or after 6 continuous week
Epistemonikos ID: 8d8a6e0904405967b767139719daae38c3bde654
First added on: Mar 24, 2022