Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Yoga arm: There will be a minimum of 16 supervised yoga classes by a certified yoga instructor, out of which the first session will be of 40 minutes, followed by 30 minutes each for the
Sponsors
Nirmal Ghati
Eligibility
Inclusion criteria
Inclusion criteria: For initial cross-sectional analysis of all screened patients - 1. Age more than or equal to 65 years 2. Diagnosed hypertensive and are on a stable antihypertensive regimen for at least 4 weeks 3. Valid baseline ABPM recording: more than or equal to 14 daytime (6 am to 12 pm midnight) and more than or equal to 7 nighttime (12 pm to 6 am) 4. Valid informed consent For RCT: All the above plus 5. Recurrent (more than 1) hypotensive episodes on 24-hour ABPM monitoring irrespective of symptoms.
Exclusion criteria
Exclusion criteria: For cross-sectional analysis 1. Not giving consent for ABPM 2. Those with extreme frailty or severe obesity, preventing proper cuff fit. For the RCT: All of the above plus 3. Severe comorbidities [End-stage CLD, End-stage CKD (with or without HD), severe lung disease, Cancer, CVA] 4. Post ACS or post-PTCA or CABG during the last 3 months 5. Patients with severe LV dysfunction (LVEF less than 35 per cent) 6. NYHA class III or IV 7. Diagnosed autonomic failure syndromes or other neurodegenerative causes of refractory orthostatic hypotension 8. Secondary causes of hypotension that require acute treatment (Like, active major bleeding, sepsis, acute adrenal insufficiency) 9. Participation in structured yoga practice within the last 3 months or regular practice 10. Severe physical or mental disabilities to perform Yoga 11. Planned for any surgical/ percutaneous intervention 12. Poor medication compliance 13. Not able to provide follow up / Not giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether yoga, in addition to conventional therapy, reduces hypotensive episodes frequency based on systolic BP identified through 24-hour ambulatory blood pressure monitoring in comparison to conventional therapy alone in elderly patients with hypertension.Timepoint: Two Years | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess whether yoga, in addition to conventional therapy, reduces hypotensive episodes frequency based on diastolic BP identified through 24-hour ambulatory blood pressure monitoring in comparison to conventional therapy alone in elderly patients with hypertension.Timepoint: Two Years;To assess the impact of yoga on quality of life in the study population (assessment by World Health Organisation Quality of Life Brief Field questionnaire (WHOQoL-BREF) scoresTimepoint: Two years;To determine the prevalence of hypotensive episodes on 24-hour ABPM in elderly patients. (cross-sectional analysis)Timepoint: Two Years;To evaluate predictors of hypotensive episodes (e.g., diabetes, CKD, number of antihypertensive medications, known CVD, frailty score, etc.) in the study population (cross-sectional analysis)Timepoint: Two years;To evaluate ABPM parameters (Systolic BP load, diastolic BP load, night time hypertension, dipping patterns, etc.) in the study population (cross-sectional analysis).Timepoint: Two years;To assess the prevalence of white-coat hypertension and masked hypertension using office BP and ABPM (cross-sectional analysis).Timepoint: Two years;To study the association of frailty (Clinical Frailty Scale)/ depressive symptoms (Geriatric Depression Scale) with hypotensive episodesTimepoint: Two years | — |
Countries
India
Contacts
Public ContactNirmal Ghati
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed