Breathing Muscle Training to Improve Blood Pressure in Adults With Type 1 Diabetes
Tests daily breathing muscle training against sham training in adults with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Inspiratory Muscle Strength Training in Adults With Type 1 Diabetes
Key facts
- Where
- Tallahassee, United StatesSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 35 years old?
Source: NCT07859943, who can take part
Where in United States
- Cardiovascular and Applied Physiology LaboratoryTallahassee, United StatesNo longer taking part
- Florida State UniversityTallahassee, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Florida State University
- Trial code
- NCT07859943
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
Time-Efficient Inspiratory Muscle Strength Training as a New Approach to Improve Cardiovascular Function Among Adults With Type 1 Diabetes
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.
Inclusion: Age 18 to 35 years; Type 1 diabetes diagnosed more than 1 year before screening; Hemoglobin A1c (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.
Exclusion: Active nicotine or illegal drug use; Diabetes-related hospitalization, including for diabetic ketoacidosis or severe hypoglycemia, within 12 months of screening; Poorly controlled hypertension, defined as systolic blood pressure at least 140 mmHg or diastolic blood pressure at least 90 mmHg; Taking diabetes medications other than insulin; Significant organ system dysfunction, such as severe pulmonary, renal, hepatic, or cardiovascular disease; Diagnosed neuropathic or psychiatric illness; Per the POWERbreathe device user manual: history of spontaneous pneumothorax; a collapsed lung that has not fully healed; a pacemaker or medical implant containing magnets or electronics; any condition of the eardrum, such as a burst eardrum that has not fully healed; Diagnosed anemia or known hemoglobin less than 10 g/dL; Structured exercise more than 150 minutes per week for the last 3 months; Pregnant, lactating, or planning to become pregnant within the study period; Unstable weight, defined as more than 5% change in the last 3 months; Alcohol consumption totaling more than 10 standard drinks per week; Unable to grant voluntary informed consent; Unable or unwilling to follow the study protocol.