Effects of Blood Flow Restriction Training on Quadriceps Muscle Strength and Biochemical Parameters among Individuals with Type 2 Diabetes Mellitus: A Protocol for a Randomised Controlled Trial

Introduction: Type 2 Diabetes Mellitus (T2DM) is characterised by poor glucose metabolism, cardiovascular complications, and musculoskeletal deterioration, which are linked to hyperglycaemia, dyslipidaemia, and sarcopenia (age-related, involuntary loss of muscle mass and strength), respectively. Blood Flow Restriction Training (BFRT) is a novel technique being used to treat various metabolic and musculoskeletal complications related to T2DM. Need of the study: BFRT is an effective training strategy for people with physical limitations. Compared to high Resistance Training (RT), mechanical load is markedly reduced with BFRT while inducing similar gains in muscle mass and strength. The present study aims to identify a better exercise programme that provides better control of diabetes and reduces the chances of cardiovascular and musculoskeletal complications. Aim: This study aims to investigate the effects of BFRT on quadriceps muscle strength, hyperglycaemia, and hyperlipidaemia in individuals with T2DM. Materials and Methods: Participants in this randomised controlled trial will be recruited using criterion-based purposive sampling from the outpatient physiotherapy department of MM Super Specialty Hospital, Mullana-Ambala, Haryana, from October 2024 to March 2025. A total of 58 individuals aged 35- 70 years, diagnosed with T2DM for a minimum of two years and with Glycosylated Haemoglobin (HbA1c) ≥6.5, will be included upon physician referral and randomised into two groups: an experimental group and a control group via block randomisation. The experimental group will undergo BFRT for four weeks, while the control group will undergo RT for four weeks. Pre- and postintervention assessments will be conducted using an isokinetic dynamometer for quadriceps muscle strength, and the HbA1c and lipid profile will be evaluated for metabolic symptoms. The Kolmogorov-Smirnov test will be used to check the normality of the data. If the data are normally distributed, paired and unpaired t-tests will be used for within-group analysis and between-group analysis, respectively. If the data are not normally distributed, the Wilcoxon Signed-Rank test and Mann-Whitney test will