6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Exercise.
- Кому может быть актуально
- Состояния в реестре: Type 2 Diabetes. Базовые параметры: 19 лет — 64 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Impact of 6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics in Adults withT2D
Обзор
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.
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.
Вмешательства
- Другое Exercise
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
Первичные конечные точки
- Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention [Срок оценки: 0-6 weeks]
Вторичные конечные точки (12)
- Change in CD4 expression before and after the 6-week intervention [Срок оценки: 0-6 weeks]
- Change in CD8 expression before and after the 6-week intervention [Срок оценки: 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 [Срок оценки: 0-6 weeks]
- Change in % of Th1 cells before and after the 6-week intervention [Срок оценки: 0-6 weeks]
- Change in % of Th2 cells before and after the 6-week intervention [Срок оценки: 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 [Срок оценки: 0-6 weeks]
- Change in CD66b+ expression before and after the 6-week intervention [Срок оценки: The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.]
- Change in CD11b+ expression before and after the 6-week intervention [Срок оценки: 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 [Срок оценки: 0-6 weeks]
- Change in % of classical monocytes before and after the 6-week intervention [Срок оценки: 0-6 weeks]
- Change in % of intermediate monocytes before and after the 6-week intervention [Срок оценки: 0-6 weeks]
- Change in % of non-classical monocytes before and after the 6-week intervention [Срок оценки: 0-6 weeks]
Критерии участия
Критерии включения
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.
Критерии исключения
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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
Канада · 1 центр
- University of British Columbia Okanagan — Kelowna
Идентификаторы
NCT: NCT07676305 · H25-02870-chronic