Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
Intervention1: Yoga: Live supervised direct + tele-yoga sessions will be offered five days/ week for 24 weeks (Total 120 sessions)
Control Intervention1: Physiotherapy: Live supervised direct + tele-p
Sponsors
National Institute of Mental Health and Neurosciences NIMHANS
Eligibility
Inclusion criteria
Inclusion criteria: Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) on disease-modifying agents (DMAs), aged between 18-50 years, with an EDSS less than 5, Patients who have never done Yoga before or who have not done Yoga in the last 6 months, Patients who have access to a smartphone, tablet or laptop with internet connectivity.
Exclusion criteria
Exclusion criteria: Progressive course of MS, Patients with concomitant /associated etiologies that could affect cognition and behavioural changes like alcoholism, psychiatric disturbances unrelated to MS, an independent psychiatric disorder, cardiac rhythm disturbances, metabolic and medical cardiac disorders which affect HRV, B12 deficiency, Any ectopic beats or artefact in the HRV recording, pregnancy, Previous head trauma, Patients with profound cognitive impairment (MMSE less than 23).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the effect of add-on yoga intervention on autonomic functions using HRV in patients with MS.Timepoint: Baseline and 24 weeks post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of add-on yoga intervention on autonomic functions using Ewing’s battery in patients with MS.Timepoint: Baseline and 24 weeks post-intervention;To assess the effects of add-on yoga intervention on depression, anxiety and QOL in patients with MS using Montgomery and Asberg Depression Rating Scale (MADRS), State-Trait Anxiety Inventory (STAI) and Multiple Sclerosis Impact Scale (MSIS-29) respectively.Timepoint: Baseline, 12 weeks and 24 weeks post-intervention;To evaluate the effect of add-on yoga intervention on autonomic functions using Composite Autonomic Symptom Scale-31 (COMPASS-31) in patients with MS.Timepoint: Baseline, 12 weeks and 24 weeks post-intervention;To study the effects of add-on yoga intervention on fatigue, pain and disability in patients with MS using Fatigue Assessment Scale (FAS), Visual Analog Scale (VAS) and Expanded Disability Status Scale (EDSS) respectively.Timepoint: Baseline, 12 weeks and 24 weeks post-intervention;To study the effects of add-on yoga intervention on peripheral blood cytokines namely TNF-a, IL-6, IL-10 and IL-12p40 in patients with MS.Timepoint: Baseline and 24 weeks post-intervention;To record the effects of add-on yoga intervention on the number and frequency of relapses in patients with MS.Timepoint: Baseline and 24 weeks post-intervention;To correlate the change in the clinical variables with the change in the immune parameters.Timepoint: Baseline and 24 weeks post-intervention | — |
Countries
India
Contacts
Public ContactKankan Gulati
National Institute of Mental Health and Neurosciences (NIMHANS)
Outcome results
None listed