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Exploring the mechanisms of yoga-based cardiac rehabilitation in heart failure via assessment of endothelial function, genomics and arterial health (Yoga-EndOmics): a study protocol

Por: Shetty · V. V. · Patil · L. R. · Patil · S. G. · Aithal · K. · Oli · A. K. · Yenagi · V. A. · Kaulgud · R. S. · Dharne · M. · Chandra Sekaran · A. M. · Prabhakaran · D.
Introduction

Heart failure (HF) remains a major global health challenge, particularly in low-resource settings where access to comprehensive cardiac rehabilitation (CR) is limited. Yoga, a culturally contextualised mind-body intervention, holds promise as an adjunctive therapy in CR. The Yoga-EndOmics study aims to evaluate the effects of Yoga-based cardiac rehabilitation (Yoga-CaRe) on gene expression, endothelial function, vascular biomarkers and clinical outcomes in systolic HF, providing mechanistic insights into its potential integration into conventional cardiac rehabilitation.

Methods and analysis

This is a prospective, randomised, open-label, blinded-endpoint (PROBE) mechanistic trial enrolling 78 patients with HF with reduced ejection fraction (HFrEF). Participants will be randomised in a 1:1 ratio to receive either a structured Yoga-CaRe intervention or enhanced standard care for 3 months. The Yoga-CaRe group will attend 20 supervised sessions with guided home practice involving tailored asanas, pranayama and meditation. Primary outcomes are changes in endothelial-dependent flow-mediated dilation (FMD) and functional exercise capacity at 3 months. Secondary outcomes include changes in arterial compliance and stiffness, circulating biomarkers of endothelial dysfunction, oxidative stress and inflammation, and immediate changes in global gene expression profiles in peripheral blood mononuclear cells following the Yoga-CaRe intervention. Data will be analysed using analysis of covariance (ANCOVA) for between-group comparisons and significant analysis of microarray (SAM) for global gene expression profiles.

Ethics and dissemination

The study has received ethical clearance from the Institutional Ethics Committee of the SDM College of Medical Sciences and Hospital, India (SDMIEC/2025/1072) and is registered with the Clinical Trials Registry of India. Findings will be disseminated through peer-reviewed journals, scientific conferences and stakeholder engagement platforms to inform future integrative strategies in HF management.

Trial registration number

CTRI/2023/12/060758

Feasibility of a cluster randomised trial on the effect of trauma life support training: a pilot study in India

Por: Gerdin Wärnberg · M. · Basak · D. · Berg · J. · Chatterjee · S. · Felländer-Tsai · L. · Ghag · G. · Juillard · C. · Khajanchi · M. · Khan · T. · Mishra · A. · Nandu · V. V. · Roy · N. · Singh · R. · Soni · K. D. · Strömmer · L.
Objective

To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.

Design

This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.

Setting

Tertiary care hospitals across metropolitan areas in India.

Participants

Adult trauma patients and residents managing these patients were included.

Interventions

ATLS or PTC training was provided for residents in the intervention arms.

Main outcomes and measures

The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.

Results

Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.

Conclusions

Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.

Trial registration number

NCT05417243.

Volumetric choice experiment to estimate the impact of e-cigarette and heated tobacco product characteristics on substitution and complementary use among adults who smoke cigarettes and recently initiated e-cigarette use

Por: Do · V. V. · Shang · C. · Huang · J. · Islam · T. · Pechacek · T. F. · Weaver · S. R.
Background

This study addresses the limited evidence of the impact of product characteristics on demand for and the substitutability of electronic cigarettes (e-cigarettes) or heated tobacco products for combusted cigarettes among people who smoke and have newly begun to use e-cigarettes.

Methods

A sample of 318 adults who smoke and recently initiated/reinitiated e-cigarette use participated in an online volumetric choice experiment in 2020–2021 to assess stated preferences for consumption and own and cross-price elasticities of three e-cigarette options (cig-a-like, vape pen or tank, closed pod system), heated tobacco product (IQOS) and their usual brand of cigarettes. Product attributes manipulated were price, flavour, level of harm, how well the product reduces cravings to smoke, and how discretely the product can be used. Multilevel zero-inflated negative binomial models were used to model the purchased quantities.

Results

Cigarettes were preferred over all alternatives. However, demand for cig-a-likes, but not IQOS, increased when cigarette prices were higher. Higher prices for e-cigarettes and IQOS did not increase demand for cigarettes. The odds of buying e-cigarettes/IQOS were higher when their harm was stated as low or unknown versus being similar to cigarettes (ie, very high). Other attributes (including various flavour options) were not significantly associated with demand for e-cigarettes or IQOS.

Conclusions

People who smoke and recently began using e-cigarettes might substitute cig-a-likes for cigarettes when cigarette prices are higher. Policies to increase the cost of combusted cigarettes as well as communicate lower relative harm and low absolute harm of e-cigarettes may facilitate switching behaviour.

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