- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07928531
Acute Blood Flow Restriction Walking on Immune Cell Phenotype and Function
Impact of Acute Blood Flow Restriction Walking on Immune Cell Phenotype and Function in Adults withT2D
To conduct a randomized control trial to determine the impact of acute blood flow restriction treadmill walking on immune cell counts, function, and phenotype in adults living with type 2 diabetes.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Participants will be randomized to a regular treadmill walking condition or treadmill walking with blood flow restriction (BFR) condition. In both groups participants will complete 32 minutes of treadmill walking at a speed and grade that 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 60%. Blood samples will be obtained pre-exercise (PRE), during the final 2 minutes of the final occlusion cycle (OCC), and 3 minutes into the recovery period post-exercise (POST) to measure outcomes.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jonathan P Little, PhD
- Numer telefonu: 250-807-9876
- E-mail: jonathan.little@ubc.ca
Lokalizacje studiów
-
-
British Columbia
-
Kelowna, British Columbia, Kanada, V1V 1V7
- Rekrutacyjny
- University of British Columbia Okanagan
-
Kontakt:
- Jonathan P Little, PhD
- Numer telefonu: 250-807-9876
- E-mail: jonathan.little@ubc.ca
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Aged 19-64 years
- Diagnosed with type 2 diabetes with current HbA1c 5.7-9.0%
- Completing <150 minutes of moderate-vigorous physical activity per week.
Exclusion Criteria:
- Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
- Unstable type 2 diabetes medication of the last 3 months
- Absolute contraindications to BFR (i.e., peripheral vascular disease)
- A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions
- A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis)
- Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely
- Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity
Plan studiów
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 |
|---|---|
|
Eksperymentalny: Treadmill walking with blood flow restriction
Treadmill walking with blood flow restriction. |
Participants will complete 32 minutes of treadmill walking at a speed and grade that elicit 40-50% heart rate reserve. 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 60%. |
|
Aktywny komparator: Treadmill Walking
Treadmill walking. |
Participants will complete 32 minutes of treadmill walking at a speed and grade that elicit 40-50% heart rate reserve. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in white blood cell count before, during, and after exercise.
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The white blood cell count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in monocyte count before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The monocyte count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in neutrophil count before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The neutrophil count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in eosinophil count before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The eosinophil count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in CD66b+ expression before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The CD66b+ expression will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in CD11b+ expression before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The CD11b+ expression will be measured using flow cytometer before, during, and after exercise |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in CD63+ expression before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The CD63+ expression will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in % of classical monocytes before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The % of classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in % of intermediate monocytes before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The % of intermediate monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in % of non-classical monocytes before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The % of non-classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in TLR-4 expression on classical monocytes before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The TLR-4 expression on classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in TLR-4 expression on intermediate monocytes before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The TLR-4 expression on intermediate monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in TLR-4 expression on non-classical monocytes before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The TLR-4 expression on non-classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in plasma IL-6 before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The plasma IL-6 concentration will be measured using a multiplex assay before, during, and after exercise |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in plasma IL-10 before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The plasma IL-10 concentration will be measured using a multiplex assay before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in plasma TNF-α before, during, and after exercise
Ramy czasowe: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The plasma TNF-α concentration will be measured using a multiplex assay before, during, and after exercise |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in 4-h LPS-induced TNF-α before and after exercise
Ramy czasowe: Pre-exercise, immediately post-exercise
|
The LPS-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA before and after exercise. |
Pre-exercise, immediately post-exercise
|
|
Change in 4-h LPS+IL10-induced TNF-α before and after exercise
Ramy czasowe: Pre-exercise, immediately post-exercise
|
The LPS+IL10-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA before and after exercise. |
Pre-exercise, immediately post-exercise
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
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
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- H25-02870 acute
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .