Inspiratory Muscle Strength Training in Adults With Type 1 Diabetes

ConditionType 1 Diabetes

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-35

SponsorFlorida State University

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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/m²

Stable insulin delivery method for the past 30 days

Disqualifiers

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

Structured exercise more than 150 minutes per week for the last 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: High-Resistance Inspiratory Muscle Strength TrainingExperimental treatment 1 intervention

Group B: Sham Inspiratory Muscle Strength TrainingSham comparator 1 intervention

Trial outcomes

Primary outcomes

Change From Baseline in Laboratory-Measured Seated Systolic Blood Pressure at 8 Weeks

Seated brachial systolic blood pressure measured in the laboratory with an automated oscillometric monitor after a period of quiet rest. This is the powered primary outcome.

Time frame

Baseline and 8 weeks

Secondary outcomes

Change From Baseline in Home Systolic Blood Pressure at 8 Weeks

Self-measured seated brachial systolic blood pressure recorded at home once weekly on a provided automated monitor, following American Heart Association home-monitoring recommendations.

Time frame

Baseline and 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida State University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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