Effects of a Yoga-based Lifestyle Intervention on Haematological, Biochemical, and Radiological Outcomes in Tribal Children and Adolescents with Sickle Cell Anaemia: A Pilot Randomised Controlled Trial

Introduction: Sickle Cell Anaemia (SCA) is a chronic haemoglobinopathy with persistent inflammation, haemolysis, and multiorgan damage. Complementary adjuncts such as yoga may modulate inflammatory and physiological pathways, but evidence in paediatric SCA from rural tribal settings is limited. This study builds on a previously published feasibility paper from the Integrated Sickle Cell Anaemia Research Program (ISCARP), which established the Yoga-Based Lifestyle Intervention (YBLI) delivery platform in Bijari village, Nandurbar district. Aim: To evaluate the effects of a six-month YBLI on haematological and biochemical parameters in children and adolescents with SCA, with exploratory descriptive radiological assessment, in a pilot randomised controlled design. Materials and Methods: This single-centre, parallel-group, pilot randomised controlled trial enrolled 69 children and adolescents (6-16 years) with electrophoresis-confirmed SCA from Dhadgaon taluka, Nandurbar district (Maharashtra, India), and randomised 1:1 to YBLI (70 min/day, 5 days/week, 24 weeks) or standard care. Allocation was concealed using sequentially numbered, opaque, sealed envelopes prepared by an independent research staff member who ran the randomisation; assessors and data analysts were blinded via barcoded sample IDs. Haematology was assessed at week 16, and biochemistry and radiology at week 24. A total of 59 participants completed follow-up; haematological analyses included 45 participants because of missing laboratory data, with sensitivity analyses using complete-case and KNN-imputed datasets. Between- and within-group comparisons used parametric or non-parametric tests as appropriate, and ANCOVA was used to adjust for baseline age imbalance (median 13 vs 11, p-value=0.037) as a post-hoc sensitivity analysis. Results: The intervention was feasible (recruitment 34.5%, adherence ≥80%, retention 85.5%) and safe, with no related adverse events. Compared with controls, the yoga group showed significant reductions in neutrophils, Neutrophil-toLymphocyte Ratio (NLR), Monocyte-to-Lymphocyte Ratio (MLR), and Systemic Immune-Inflammation Index (SII) (p-value ≤ 0.01), and significant within-group reductions in Alkaline Phosphatase (ALP), Serum Glutamic Oxaloacetic Transaminase (SGOT), total bilirubin, and the SGOT/ALP ratio (p-value ≤ 0.01). After ANCOVA adjustment for age, effect direction and significance for Complete Blood Count (CBC) variables and derived ratios (co-primary outcomes), and biochemical parameters and ratios (secondary outcomes), were preserved. Conclusion: The present study showed that a six-month YBLI was feasible, safe, and associated with exploratory improvements in selected inflammatory, immune, and biochemical indices in paediatric SCA. Findings are hypothesis-generating and require confirmation in adequately powered, blinded, multicentre trials.