Health Condition 1: F31- Bipolar disorder
Conditions
Interventions
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
Sponsors
DST SATYAM (Science and Technology for Yoga and Meditation)
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Exclusion criteria for both cases and controls: Patients with comorbid alcohol, tobacco, cannabis, or other drug dependence as per ICD-10 DCR criteria, patients with current active infections such as tuberculosis (on 8 weeks active phase treatment) or COVID-19 (within the last 3 weeks), comorbid autoimmune diseases, Pregnancy or lactation, acute unstable medical illnesses which may prevent the active participation of the study participant in the various study procedures, comorbid poorly controlled chronic medical illnesses such as hypertension (BP more than180 mmHg systolic or more than 110 mmHg diastolic) or diabetes mellitus (FBS more than 180 mg% or PPBS more than 300 mg% or Random BS more than 300 mg%) or poorly controlled hyper- or hypothyroidism within the last one month period, pre-existing hepatic and renal disease, connective tissue diseases, and malignancies, and individuals who are already practising some form of structured exercises or yoga on a regular basis will also be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sympathovagal balance (LF:HF ratio)Timepoint: Change in LF:HF ratio from 0 weeks (baseline) to the end of 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr R Rajalakshmi
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Outcome results
None listed