6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
23 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
20
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Jonathan P Little, PhD
- Numer telefonu: 250-807-9876
- E-mail: jonathan.little@ubc.ca
Lokalizacje studiów
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-
British Columbia
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Kelowna, British Columbia, Kanada, V1V 1V7
- Rekrutacyjny
- University of British Columbia Okanagan
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Kontakt:
- Jonathan P Little, PhD
- Numer telefonu: 250-807-9876
- E-mail: jonathan.little@ubc.ca
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Treadmill walking with blood flow restriction
Treadmill walking with blood flow restriction performed 3 days per week for 6 weeks.
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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.
|
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Aktywny komparator: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention.
|
0-6 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in CD4 expression before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
The CD4 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in CD8 expression before and after the 6-week intervention
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
|
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
Ramy czasowe: 0-6 weeks
|
The % Th17 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in CD66b+ expression before and after the 6-week intervention
Ramy czasowe: 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.
|
|
Change in CD11b+ expression before and after the 6-week intervention
Ramy czasowe: 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
Ramy czasowe: 0-6 weeks
|
The CD63+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in % of classical monocytes before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
The % of classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in % of intermediate monocytes before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
The % of intermediate 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 non-classical monocytes before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
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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
Ramy czasowe: 0-6 weeks
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The TLR-4 expression on classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
The TLR-4 expression on intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention
Ramy czasowe: 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.
|
0-6 weeks
|
|
Change in white blood cell count before and after the 6-week intervention
Ramy czasowe: 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
|
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Change in monocyte count before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
The monocyte count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in neutrophil count before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
The neutrophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in eosinophil count before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
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The eosinophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in plasma IL-6 before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
The plasma IL-6 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in plasma IL-10 before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
The plasma IL-10 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in plasma TNF-α before and after the 6-week intervention
Ramy czasowe: 0-6 weeks
|
The plasma TNF-α concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in 4-h LPS-induced TNF-α before and after the 6-week intervention
Ramy czasowe: 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.
|
0-6 weeks
|
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Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention
Ramy czasowe: 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.
|
0-6 weeks
|
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Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention
Ramy czasowe: 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
Ramy czasowe: 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.
|
0-6 weeks
|
Współpracownicy i badacze
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
11 lutego 2026
Zakończenie podstawowe (Szacowany)
31 grudnia 2027
Ukończenie studiów (Szacowany)
31 grudnia 2027
Daty rejestracji na studia
Pierwszy przesłany
23 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
30 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
30 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
23 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- H25-02870-chronic
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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