ArticlePloS one2026
Testing the feasibility of blood flow restriction training to enhance the HEALTH benefits of exercise in individuals with type 2 diabetes (BOOST-HEALTH Trial): Study Protocol.
Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07196371 (Testing the Feasibility of Blood Flow Restriction Training to Enhance the Health Benefits of Exercise in Individuals With Type 2 Diabetes), which is not on this map. Not yet cited in PubMed.
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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: a Pilot Randomized Controlled Trial
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6 authors.
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Abstract
introductionIndividuals 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.
objectivesThis 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).
methodsBOOST-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 (VO2max) 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. DISCUSSION: Results of this study could establish BFR training as a novel therapeutic modality to augment the effects of exercise in individuals with T2D. Findings will inform whether a larger, definitive efficacy trial is warranted and will guide exercise professionals on the potential integration of AT+BFR as an alternative strategy to enhance the benefits of exercise in this population.
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