Effect of Resisted Blood Flow Restriction

Overview

The goal of this clinical trial is to investigate the effect of adding resisted blood flow restriction (BFR) training to a standard exercise program in adults aged 50-60 with Type 2 Diabetes Mellitus (T2DM). The main questions it aims to answer are: Does adding BFR training significantly increase muscle strength compared to standard exercise alone? Does the BFR intervention lead to measurable improvements in balance and physical function? Researchers will compare a group performing standard therapeutic exercise combined with BFR to a control group performing the same exercise program without BFR to see if the BFR group achieves superior gains in strength and functional independence. Participants will: Complete a 12-week supervised exercise program in an outpatient setting. Wear compression cuffs on their limbs during low-intensity resistance exercises (for the BFR group). Undergo assessments for muscle strength (via handheld dynamometry), balance, and functional mobility before and after the intervention.

While high-load resistance training is the gold standard for improving muscle quality in Type 2 Diabetes Mellitus (T2DM), individuals with long-standing disease (5+ years) often present with microvascular complications or joint pain that make high-mechanical loads unsafe. Blood Flow Restriction (BFR) training uses a pneumatic cuff to induce metabolic stress-specifically lactate accumulation and growth hormone surges-allowing for muscle hypertrophy and strength gains at loads as low as 20-30% of a person's one-repetition maximum (1-RM). Intervention Workflow 1. Baseline Assessment Phase 1-RM Testing: Participants will undergo 1-RM testing for lower-limb exercises (leg press and knee extension) to calibrate training loads. Limb Occlusion Pressure (LOP): Using a personalized pressure system . the investigator will determine the minimum pressure required to fully occlude arterial flow in the sitting position. 12-Week Exercise Protocol Frequency: Sessions will occur 3 times per week on non-consecutive days. Repetition Scheme: Each BFR exercise will follow the standard 75-repetition protocol: one set of 30, followed by three sets of 15 repetitions (30-15-15-15). Rest Intervals: 30-second rest periods will be strictly maintained between sets while the cuffs remain inflated to ensure continuous metabolite accumulation. Standard Exercise Control: The control group will perform the identical exercise volume and repetition scheme but without cuff inflation (low-load RT only). 3\. Safety and Monitoring Glucose Monitoring: Capillary blood glucose will be measured pre- and post-session to monitor for hypoglycemia, a critical safety measure in T2DM exercise studies. Perceived Exertion: The Borg Scale (6-20) will be used to monitor intensity, ensuring participants remain within a "moderate" effort range. Primary Strength Endpoint: Change in isometric and dynamic leg strength measured via Handheld Dynamometry and 1-RM re-testing at week 12. Functional Mobility: The Timed Up and Go (TUG) test and a 6-Minute Walk Test to assess real-world independence. Balance Evaluation: Assessment of postural sway using the Berg Balance Scale or computerized platform testing to quantify fall risk.