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Testing the feasibility of blood flow restriction training to enhance the HEALTH benefits of exercise in individuals with type 2 diabetes
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Testing the feasibility of blood flow restriction training to enhance the HEALTH benefits of exercise in individuals with type 2 diabetes
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Journal Article
Testing the feasibility of blood flow restriction training to enhance the HEALTH benefits of exercise in individuals with type 2 diabetes
2026
Overview
Individuals with type 2 diabetes (T2D) display reduced cardiorespiratory fitness, a strong predictor of premature mortality and T2D-related complications. Aerobic training (AT) enhances cardiorespiratory fitness and is a cornerstone in T2D management. Emerging data suggest that AT combined with blood flow restriction (AT+BFR) may elicit greater improvements in cardiorespiratory fitness than typical AT in healthy individuals. However, the feasibility and effects of AT+BFR in individuals with T2D remain unclear. This protocol describes the BOOST-HEALTH trial, which aims to 1) evaluate the feasibility of a 6-week AT+BFR intervention in adults with T2D, and 2) estimate preliminary effect sizes for changes in cardiorespiratory fitness, glycemic outcomes, and quality of life compared with standard care AT (AT- stdCare). BOOST-HEALTH (NCT07196371) is a single-blinded, multisite, randomized clinical pilot trial with two parallel treatment arms. Sixty adults with T2D (n = 30 female) will be randomized to 6 weeks of AT+BFR or AT-stdCare. Both groups will complete supervised treadmill walking three times per week (96 min/week) at 40-50% heart rate reserve. The AT+BFR group will exercise with BFR cuffs inflated to 60-80% of limb arterial occlusion pressure, whereas the AT-stdCare group will exercise without BFR. Primary outcomes will assess feasibility, including recruitment, enrollment, adherence, and retention. Secondary outcomes will estimate effect sizes for changes in cardiorespiratory fitness (VO.sub.2max) and continuous glucose monitoring metrics to inform outcome selection and sample size calculations for future definitive trials. Outcomes will be assessed at baseline and post-intervention.
Publisher
Public Library of Science
