Study protocol on effectiveness of yoga practice on composite biomarker age predictors (yBioAge) in an elderly Indian cohort- two-armed open label randomized controlled trial

Abstract

IntroductionThe recent development of robust indices to quantify biological aging, along with the dynamic epidemiological transitions of population aging generate the unmet need to examine the extent up to which potential interventions can delay, halt or temporarily modulate aging trajectories.Methods and analysisThe study is a two-armed, open label randomised controlled trial. We aim to recruit 166 subjects, aged 60–75 years from the residential communities and old age clubs in Bangalore city, India, who will undergo randomisation into intervention or control arms (1:1). Intervention will include yoga sessions tailored for the older adults, 1 h per day for 5 days a week, spread for 12 months. Data would be collected at the baseline, 26th week and 52nd week. The primary outcome of the study is estimation in biological age with yoga practice. The secondary outcomes will include cardinal mechanistic indicators of aging- telomere length, interleukin-6 (IL-6), tumor necrosis factor receptor II (TNF-RII), high sensitivity c-reactive protein (hsCRP)], insulin signaling [insulin and IGF1], renal function [cystatin], senescence [growth differentiating factor 15 (GDF-15)] and cardiovascular function [N-terminal B-type natriuretic peptides (NT-proBNP)]. Analyses will be by intention-to-treat model.Ethics & disseminationThe study is approved by the Institutional Ethics Committee of Swami Vivekananda Yoga Anusandhana Samsthana University, Bangalore (ID:RES/IEC-SVYASA/242/2022). Written informed consent will be obtained from each participant prior to inclusion.Trial registration numberCTRI/2022/07/044442.