A clinical trial to study the effect of Pranayamas as an additional treatment for managing patients with Bipolar I disorder

INTERVENTION: Intervention1: A pranayama module will be given as a standalone adjuvant treatment for individuals with bipolar I disorder (Test group 1): Test group 1 The participants will be asked to report to the Autonomic Function Testing (AFT) laboratory in the Department of Physiology between 8 amâ??11 am for assessment of study parameters (cardiac sympathovagal status, cognition, stress levels, and functional status). The duration required for recording the study parameters will be two hours. Then the participants will be taken to the Yoga Centre at JIPMER, Puducherry, for administration of pranayama therapy. The pranayama session will be conducted for 40 â?? 45 minutes once a week, for three months, under the supervision of a certified yoga trainer. The participants will be advised to perform the prescribed yoga practice for the rest of the si Xdays at home under the supervision of a caregiver/relative. The details of the structured pranayama practice will be handed over as a pamphlet to the participants. They will be taught to perform the prescribed pranayama module to their capacity. The caregiver/relative will be asked to supervise and maintain a compliance diary to enter the patients daily pranayama practice. The same will be cross‐checked during the patients subsequent visit to the yoga centre. Periodic phone calls will also be made to motivate the patients to practice the pranayama. The study parameters will be assessed again at the end of 6 and 12 weeks during their routine follow‐up visit to the Psychiatry OPD. Control Intervention1: Bipolar I disorder patients receiving conventional treatment alone (Test group 2).: Test group 2: The participants will be asked to report to the Autonomic Function Testing (AFT) laboratory in the Department of Physiology between 8 amâ??11 CONDITION: Health Condition 1: F31‐ Bipolar disorder PRIMARY OUTCOME: Sympathovagal balance (LF:HF ratio)Timepoint: Change in LF:HF ratio from 0 weeks (baseline) to the end of 6 and 12 weeks SECONDARY OUTCOME: Resting heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, rate pressure product ; ; Time domain indices of HRV‐ SDNN, RMSSD, pNN50 ; Frequency domain indices of HRV‐ LF power, HF power, LF nu, HF nu, Total power ; ; BRS Parameters ; ; Cognition‐ P300 ; ; Auditory reaction time (ART), visual reaction time (VRT) ; ; Simple cognitive tests â?? to test Attention (â??Aâ?? Random Letter Test), Executive function (Fist‐Palm‐Side test, Fist‐Ring test, Reciprocal co‐ordination test), Language (Handedness, Verbal fluency‐ Animal naming, FAS test), Memory (Digit Repetition, Orientation, Verbal story, Visual memory), Visuospatial, Calculation (Verbal rote, verbal complex), Abstraction (Proverb interpretation, Similarities, Differences) ; ; Perceived Stress Score (PSS) ; ; Functioning Assessment Short Test‐FAST scores ; ; Compliance with Pranayama‐ yes/no (weekly %) ; Timepoint: Change in these study parameters from 0 week ; (baseline) to the end of 6 and 12 weeks INCLUSION CRITERIA: Inclusion criteria for cases: Patients diagnosed with Bipolar I Disorder as per ICD‐10 DCR (International Classification of Diseases 10th edition â?? Diagnostic Criteria for Research) presently in euthymic state defined by current Young Mania Rating Scale (YMRS) score of 7 or less and Hamilton Depression Rating Scale (HDRS) of 7 or less, on stable doses of mood stabilisers and/or antipsychotics for the last 6 weeks. (Dose: Diazepam less than or equal to10 mg, Clonazepam less than or equal to 0.5mg or Lorazepam less than or equal to 2mg) Inclusion criteria for control: Age and gender‐matched healthy subjects will be recruited from within the institutional campus from among the healthcare workers and other staff of the hospital.