Inspiratory Muscle Strength Training in Adults With Type 1 Diabetes
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
Approximately two million Americans live with type 1 diabetes, and cardiovascular disease is the leading cause of death in this population. After glycemic control, systolic blood pressure is the leading modifiable cardiovascular risk factor. Traditional aerobic exercise lowers blood pressure and improves vascular function, but most adults with type 1 diabetes do not meet physical activity recommendations, citing time constraints and concern about exercise-associated hypoglycemia.
Inspiratory muscle strength training (IMST) requires about five minutes per day, is performed seated at home with a commercially available handheld device, and is unlikely to provoke hypoglycemia. A retrospective analysis of five independent trials in 128 adults reported a 9 mmHg reduction in casual systolic blood pressure following high-resistance IMST compared with sham training, with effects that appear consistent across age, sex, health status, and baseline blood pressure. No study has examined IMST in people with type 1 diabetes.
Participants are randomized in a 2:1 ratio to high-resistance IMST or very-low-resistance sham IMST. Randomization uses a computer-generated sequence held by an unmasked team member who is responsible only for setting device resistance; participants, investigators, and outcome assessors remain masked to group assignment. All participants complete approximately 56 daily training sessions over eight weeks, each consisting of five bouts of six forceful inhalations with about 30 seconds of rest between bouts.
Maximal inspiratory pressure is measured at weeks 0, 2, 4, 6, and 8. For the high-resistance group, device 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. The sham group trains at 15% of maximal inspiratory pressure throughout. Participants are debriefed on their group assignment at the end of the post-training visit.
Testing visits at week 0 and week 8 include laboratory blood pressure, brachial artery flow-mediated dilation and post-occlusion reactive hyperemia by high-resolution ultrasound, central blood pressure and arterial stiffness by applanation tonometry, and isometric handgrip exercise testing with post-exercise circulatory occlusion. Participants measure their blood pressure at home once weekly on a provided automated monitor during weeks without a laboratory visit. Brief check-in contacts occur on odd weeks and device adjustment visits on even weeks. An optional follow-up visit repeating all assessments is offered at week 12.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jonathan Hoch
- Numer telefonu: 8506441281
- E-mail: chhs-cap@fsu.edu
Lokalizacje studiów
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Florida
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Tallahassee, Florida, Stany Zjednoczone, 32306
- Florida State University
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Tallahassee, Florida, Stany Zjednoczone, 32306
- Cardiovascular and Applied Physiology Laboratory
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Kontakt:
- Joseph Watso, PhD
- Numer telefonu: 8506441281
- E-mail: jwatso@fsu.edu
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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 Criteria:
- 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
- Pregnant, lactating, or planning to become pregnant within the study period
- Unstable weight, defined as more than 5% change in the last 3 months
- Significant organ system dysfunction, such as severe pulmonary, renal, hepatic, or cardiovascular disease
- Diagnosed anemia or known hemoglobin less than 10 g/dL
- Diagnosed neuropathic or psychiatric illness
- Active nicotine or illegal drug use
- Alcohol consumption totaling more than 10 standard drinks per week
- Unable to grant voluntary informed consent
- Unable or unwilling to follow the study protocol
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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. |
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. |
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Pozorny komparator: 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. |
Daily home-based inspiratory muscle strength training using a POWERbreathe K3 device for eight weeks, at 15% of maximal inspiratory pressure throughout. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Baseline in Laboratory-Measured Seated Systolic Blood Pressure at 8 Weeks
Ramy czasowe: Baseline and 8 weeks
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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. |
Baseline and 8 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change From Baseline in Home Systolic Blood Pressure at 8 Weeks
Ramy czasowe: Baseline and 8 weeks
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Self-measured seated brachial systolic blood pressure recorded at home once weekly on a provided automated monitor, following American Heart Association home-monitoring recommendations. |
Baseline and 8 weeks
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Joseph C Watso, Florida State University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY00007503
- R03HL183276 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
De-identified individual participant-level data (IPD) that correspond directly to the key outcomes reported in peer-reviewed publications will be preserved and shared.
Ramy czasowe udostępniania IPD
Data will be made available after peer-review publication of the final dataset, but no later than 1 year after the completion of data collection. Data will remain available for a period of at least 10 years, per the University's guidelines for records retention.
Kryteria dostępu do udostępniania IPD
Access will be unrestricted and open to the scientific community without controlled-access barriers. All data will be fully de-identified in compliance with HIPAA guidelines by removing direct/indirect personal identifiers and assigning coded study IDs prior to upload. Datasets will be structured in open, interoperable formats (CSV and/or TXT) requiring no specialized software to access. Datasets will be archived and publicly searchable in Zenodo (a FAIR-aligned public generalist repository) and assigned a persistent Digital Object Identifier (DOI). Summary results will also be submitted directly to ClinicalTrials.gov.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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