6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
23 июня 2026 г. обновлено: Jonathan Little, University of British Columbia
Impact of 6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics in Adults withT2D
To conduct a randomized control trial to determine the impact of 6-weeks of blood flow restriction training on immune cell function and bioenergetics in adults living with type 2 diabetes.
Обзор исследования
Подробное описание
Participants will be randomized to a regular treadmill walking group or treadmill walking with blood flow restriction (BFR) group for 6 weeks.
In both groups participants will complete treadmill walking on 3 days per week for 6 weeks.
During week 1 participants will walk for 21 minutes during each session which will be increased to 32 minutes for the remaining 5 weeks of the study.
In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve.
In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP).
The cuffs will remain inflated for the entire session but will deflate for 1 minute every 10 minutes based on safety recommendations.
The percentage of LOP will progressively increase over the course of the intervention.
Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively.
All outcomes will be assessed at baseline before randomization and at the end of the 6-week intervention.
Тип исследования
Интервенционный
Регистрация (Оцененный)
20
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Jonathan P Little, PhD
- Номер телефона: 250-807-9876
- Электронная почта: jonathan.little@ubc.ca
Места учебы
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British Columbia
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Kelowna, British Columbia, Канада, V1V 1V7
- Рекрутинг
- University of British Columbia Okanagan
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Контакт:
- Jonathan P Little, PhD
- Номер телефона: 250-807-9876
- Электронная почта: jonathan.little@ubc.ca
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
A. Aged 19-64 years. B. Diagnosed with type 2 diabetes with current HbA1c 5.7-9.0% C. Completing <150 minutes of moderate-vigorous physical activity per week.
Exclusion Criteria:
A. Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
B. Unstable type 2 diabetes medication of the last 3 months C. Absolute contraindications to BFR (i.e., peripheral vascular disease) D. A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions E. A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis) F. Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely G. Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Treadmill walking with blood flow restriction
Treadmill walking with blood flow restriction performed 3 days per week for 6 weeks.
|
In both groups participants will complete treadmill walking on 3 days per week for 6 weeks.
During the first week participants will walk continuously for 21 minutes during each training session which will be increased to 32 minutes per training session for weeks 2-6.
In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve.
In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP).
The cuffs will remain inflated for the entire session but will deflate for 1 min every 10 min based on safety recommendations.
The percentage of LOP will progressively increase over the course of the intervention.
Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively.
|
|
Активный компаратор: Treadmill Walking
Treadmill walking performed 3 days per week for 6 weeks.
|
In both groups participants will complete treadmill walking on 3 days per week for 6 weeks.
During the first week participants will walk continuously for 21 minutes during each training session which will be increased to 32 minutes per training session for weeks 2-6.
In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve.
In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP).
The cuffs will remain inflated for the entire session but will deflate for 1 min every 10 min based on safety recommendations.
The percentage of LOP will progressively increase over the course of the intervention.
Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention.
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0-6 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in CD4 expression before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The CD4 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
|
Change in CD8 expression before and after the 6-week intervention
Временное ограничение: The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
|
Change in % of T regulatory cells before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The % T regulatory cells will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in % of Th1 cells before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The % Th1 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in % of Th2 cells before and after the 6-week intervention
Временное ограничение: The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
|
|
Change in % of Th17 cells before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The % Th17 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in CD66b+ expression before and after the 6-week intervention
Временное ограничение: The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
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Change in CD11b+ expression before and after the 6-week intervention
Временное ограничение: The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
|
Change in CD63+ expression before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The CD63+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in % of classical monocytes before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The % of classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in % of intermediate monocytes before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The % of intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in % of non-classical monocytes before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The % of non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in TLR-4 expression on classical monocytes before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The TLR-4 expression on classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The TLR-4 expression on intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The TLR-4 expression on non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in white blood cell count before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The white blood cell count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in monocyte count before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The monocyte count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in neutrophil count before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The neutrophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in eosinophil count before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The eosinophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in plasma IL-6 before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The plasma IL-6 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in plasma IL-10 before and after the 6-week intervention
Временное ограничение: 0-6 weeks
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The plasma IL-10 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in plasma TNF-α before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The plasma TNF-α concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in 4-h LPS-induced TNF-α before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The LPS-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The LPS+IL10-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.
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0-6 weeks
|
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Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention
Временное ограничение: 0-6 weeks
|
The CD3/CD28 stimulated INF-γ concentration will be measured from T-cell culture supernatant using an ELISA at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in PMA/Ionomysin induced INF-γ before and after the 6-week
Временное ограничение: 0-6 weeks
|
The PMA/Ionomysin induced INF-γ concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.
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0-6 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
11 февраля 2026 г.
Первичное завершение (Оцененный)
31 декабря 2027 г.
Завершение исследования (Оцененный)
31 декабря 2027 г.
Даты регистрации исследования
Первый отправленный
23 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
23 июня 2026 г.
Первый опубликованный (Действительный)
30 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
30 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
23 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- H25-02870-chronic
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .