Inspiratory Muscle Strength Training for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Joseph C Watso
Principal Investigator
Florida State University
Are You a Good Fit for This Trial?
This trial is for adults with type 1 diabetes. Participants should not have any conditions that would prevent them from safely doing breathing exercises or following the study instructions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- High-Resistance Inspiratory Muscle Strength Training
Trial Overview
The study tests if daily high-resistance inspiratory muscle strength training (using a special breathing device) for eight weeks can lower blood pressure and improve blood vessel health in people with type 1 diabetes, compared to a low-resistance sham version.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants complete daily inspiratory muscle strength training using a POWERbreathe K3 device for eight weeks. Each session consists of five bouts of six forceful inhalations against resistance, with approximately 30 seconds of rest between bouts, for 30 training breaths per day. Resistance is set to a graded percentage of the participant's current maximal inspiratory pressure: 55% during weeks 1-2, 65% during weeks 3-4, and 75% during weeks 5-8.
Participants complete daily inspiratory muscle strength training using a POWERbreathe K3 device for eight weeks. Each session consists of five bouts of six forceful inhalations against resistance, with approximately 30 seconds of rest between bouts, for 30 training breaths per day. Resistance is set to 15% of the participant's maximal inspiratory pressure throughout the eight weeks.
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Who Is Running the Clinical Trial?
Florida State University
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
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