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Inspiratory Muscle Strength Training in Adults With Type 1 Diabetes

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 24 words
    • Site contacts updated at 1 of 2 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Florida State University
85 trials monitored
See 5 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Hypertension
1,925 trials monitored
See 99 trials at risk
Type 1 Diabetes
886 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT07859943
Lead Sponsor Florida State University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Type 1 Diabetes
Related terms Diabetes Mellitus, Type 1, Hypertension
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov