Study of effect of Pranayama on Autonomic function in Bipolar 1 disorder patients.
- Conditions
- Health Condition 1: - Health Condition 2: F317- Bipolar disorder, currently in remission
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
Patients diagnosed with Bipolar Disorder as per ICD-10 DCR (International Classification of Diseases 10th edition – Diagnostic Criteria for Research)
Either gender
Age between 18 to 45 years
Presently in the euthymic state defined by the 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 stabilizers and/or
antipsychotics for the last 6 weeks
Patients with comorbid alcohol, tobacco, cannabis or another drug dependence
Patients with current active infections such as
tuberculosis on active phase treatment or COVID-19 within the last 3 weeks
Comorbid autoimmune diseases
Pregnant and lactating women
Pre-existing endocrine disorders
Pre-existing chronic illness like diabetes, hypertension, hepatic and renal disease, connective tissue diseases, malignancies
Individuals who are already practicing some form of structured pranayama or yoga on a regular basis will also be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in sympathovagal balance (LF/HF ratio) in Bipolar I disorder patients receiving Pranayama therapy and conventional treatment for 8 weeks in comparison to the patients receiving conventional treatment onlyTimepoint: Improvement in sympathovagal balance (LF/HF ratio) in Bipolar I disorder patients receiving Pranayama therapy and conventional treatment for 8 weeks in comparison to the patients receiving conventional treatment only
- Secondary Outcome Measures
Name Time Method Improvement in <br/ ><br>Blood pressure <br/ ><br> <br/ ><br>Time-domain and frequency-domain indices of HRV <br/ ><br> <br/ ><br>HR and BP response to standing <br/ ><br> <br/ ><br>HR response to deep breathing <br/ ><br> <br/ ><br>BP response to isometric handgrip <br/ ><br> <br/ ><br>BRS Parameters - stroke volume, CO, TPRS, BRS value <br/ ><br> <br/ ><br>Serum levels of cortisol, hs-CRP, IL-4, BDNF, MDA levels <br/ ><br> <br/ ><br>Cognition- P300, Visual Reaction Time(VRT), Auditory Reaction Time(ART) <br/ ><br> <br/ ><br>Stress score (PSS) <br/ ><br> <br/ ><br>PSQI score, ESS score <br/ ><br> <br/ ><br>WHO-QoL BREF <br/ ><br> <br/ ><br>Positive and Negative Affect Schedule (Short from)- PANAS-SF score <br/ ><br> <br/ ><br>Compliance to Pranayama- yes/no (weekly %)Timepoint: 2 months of Pranayama therapy improves the secondary outcome variables