Inspiratory Muscle Strength Training in Adults With Type 1 Diabetes

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT07859943
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • High-Resistance Inspiratory Muscle Strength Training — DEVICE
    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.
  • Sham Inspiratory Muscle Strength Training — DEVICE
    Daily home-based inspiratory muscle strength training using a POWERbreathe K3 device for eight weeks, at 15% of maximal inspiratory pressure throughout.

Study Details

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.

Key Dates

First listed
Oct 6, 2026
Start date
Jan 1, 2027
Status verified
Oct 2026
Primary completion
Sep 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: High-Resistance Inspiratory Muscle Strength Training
    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.
  • Sham Comparator: Sham Inspiratory Muscle Strength Training
    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.

Primary Outcome Measure

Change From Baseline in Laboratory-Measured Seated Systolic Blood Pressure at 8 Weeks [ Time Frame: Baseline and 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cardiovascular and Applied Physiology LaboratoryTallahasseeFlorida32306
Joseph Watso, PhD
[email protected]
8506441281
Florida State UniversityTallahasseeFlorida32306-

Find similar trials in Tallahassee, FL

Nationwide
Type 1 diabetes trialsEndocrinology trials
By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Cardiovascular and Applied Physiology Laboratory· Tallahassee, FLFlorida State University· Tallahassee, FL

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