Effect of Pranayama on non-motor symptoms in patients with Parkinsons disease.

There is paucity of literature on the impact of Pranayama on patients with Parkinson’s Disease. All the eligible patients giving written informed consent will undergo baseline evaluation of motor and non-motor functions. Motor function rating will be done by Clinician rated validated MDS UPDRS Part Ill scale. Non motor symptom scale will be administered by the trained investigator. All patients will be evaluated with Montreal Cognitive Assessment Scale, Frontal Assessment Battery and their baseline quality of life will be measured using Parkinson’s Discase Quality of Life instrument, PDO-39. Cognitive evoked potential P300 will be recorded in all the patients at baseline. The P300 component, of cognitive potential, is a positive potential elicited by the recognition of a rare stimulus (oddball paradigm) within a series of frequent stimuli and corresponds to the largest positive wave after the N1-P2 complex. Odd Ball paradigm will be used for recording the P300 with recording electrode placed over centroparieral area as per the 10-20 system of electrode placement and the reference electrode being the ear lobes. Low frequency Filter and High Frequency Filter will be set at 0.01 Hz and 100 Hz respectively with sweep speed. A detailed proforma as per the

annexure regarding the patient’s clinical details will be filled and details of the dose and duration of each of the medicines being taken will be entered. Equivalent levodopa dose will be calculated for each of the patients. The patients will be randomly allocated to one of the 2 groups: the Pranayama group and the Control group. The Control group will continue to get standard anti parkinsonian medicines and the Pranayama group will practice the Pranayama Protocol as per the annexure. The intervention group will be taught 4 Pranayama- Anulom Vilom, Kapalbhati, Bhramri and Bhrastika for around a week by trained personnel. Instructions will be given at the hospital initially and once it is ascertained that the patient and their primary care giver if available have learnt the technique, patients will be instructed to undertake the Pranayama at home at least once a day and at least 5 times a week. All the patients in the Pranayama group will be encouraged to do Pranayama twice a day (once in the morning and once in the evening). All the patients/ caregiver will record the date/day and duration of Pranayama undertaken each day. The immediate caregiver or family member will be requested to assist and monitor the patient’s performance of the Pranayama. The records of the performance of the Pranayama will be received telephonically every fortnightly and patient/ family member will be asked to report any specific issues encountered for appropriate action and suggestions as required.

Patients and caregivers will be requested to make a video of the performance of pranayama and share on a mobile number given to him/her if required. If any difficulty or incorrect performance of the Pranayama is noted, appropriate instructions will be given again, by video call or physical mode as required and feasible. If any difficulty in performing or observed to be incorrectly performing the Pranayama, will be given instructions again, by video call or physical mode as required or feasible. Follow up visit will be after 12 weeks. At 12 week follow up visit, patients will be revaluated with repeat MDS UPDRS Part III, on motor symptom scale score, MoCA (Montreal cognitive assessment score), FAB (Frontal assessment battery), Cognitive Evoked Potential P300, HAM-A and HAM-D (Hamilton scales for anxiety and depression) and PDQ 39 (Parkinson’s disease quality of life index). Change in scores will be recorded statistical analysis will be performed on the data collected.