Florida State University
Adults with type 1 diabetes have elevated cardiovascular disease risk, and systolic blood pressure is a leading modifiable contributor to that risk. Aerobic exercise lowers blood pressure but poses time and glycemic-management barriers for people with type 1 diabetes. Inspiratory muscle strength training is a brief, home-based, device-based intervention that takes about five minutes per day and has lowered systolic blood pressure in other adult populations. This pilot trial will test whether eight weeks of daily high-resistance inspiratory muscle strength training lowers blood pressure and improves vascular function in adults with type 1 diabetes. Participants will be randomized 2:1 to high-resistance or very-low-resistance sham training using a POWERbreathe K3 device and will complete 30 training breaths per day at home for eight weeks. Outcomes are assessed before and after the training period.
Approximately two million Americans live with type 1 diabetes, and cardiovascular disease is the leading cause of death in this population. After glycemic control, systolic blood pressure is the leading modifiable cardiovascular risk factor. Traditional aerobic exercise lowers blood pressure and improves vascular function, but most adults with type 1 diabetes do not meet physical activity recommendations, citing time constraints and concern about exercise-associated hypoglycemia. Inspiratory muscle strength training (IMST) requires about five minutes per day, is performed seated at home with…
Inclusion Criteria: Age 18 to 35 years Type 1 diabetes diagnosed more than 1 year before screening HbA1c 10.0% or less within the last 3 months (may be measured at screening) Body mass index 18 to 29.9 kg/m\^2 Stable insulin delivery method for the past 30 days Ability to read all device instructions and insulin pump settings Estimated glomerular filtration rate at least 60 mL/min/1.73 m\^2 within the last 3 months (may be measured at screening) Use of an insulin pump or insulin delivery by multiple daily injections Attendance at 3 or more diabetes care visits over the past 12 months Exclusi…
Daily home-based inspiratory muscle strength training using a POWERbreathe K3 device for eight weeks, at 55% of maximal inspiratory pressure during weeks 1-2, 65% during weeks 3-4, and 75% during weeks 5-8. Maximal inspiratory pressure is re-measured at weeks 0, 2, 4, 6, and 8 and resistance is adjusted accordingly.
Daily home-based inspiratory muscle strength training using a POWERbreathe K3 device for eight weeks, at 15% of maximal inspiratory pressure throughout.
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