6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
23. června 2026 aktualizováno: 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.
Přehled studie
Detailní popis
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 studie
Intervenční
Zápis (Odhadovaný)
20
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Jonathan P Little, PhD
- Telefonní číslo: 250-807-9876
- E-mail: jonathan.little@ubc.ca
Studijní místa
-
-
British Columbia
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Kelowna, British Columbia, Kanada, V1V 1V7
- Nábor
- University of British Columbia Okanagan
-
Kontakt:
- Jonathan P Little, PhD
- Telefonní číslo: 250-807-9876
- E-mail: jonathan.little@ubc.ca
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
|
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in CD4 expression before and after the 6-week intervention
Časové okno: 0-6 weeks
|
The CD4 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in CD8 expression before and after the 6-week intervention
Časové okno: The CD8 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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The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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Change in % of T regulatory cells before and after the 6-week intervention
Časové okno: 0-6 weeks
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The % T regulatory cells 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 Th1 cells before and after the 6-week intervention
Časové okno: 0-6 weeks
|
The % Th1 cells 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 Th2 cells before and after the 6-week intervention
Časové okno: 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.
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|
Change in % of Th17 cells before and after the 6-week intervention
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 0-6 weeks
|
The CD63+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in % of classical monocytes before and after the 6-week intervention
Časové okno: 0-6 weeks
|
The % of 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 % of intermediate monocytes before and after the 6-week intervention
Časové okno: 0-6 weeks
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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
Časové okno: 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
Časové okno: 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.
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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
Časové okno: 0-6 weeks
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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
Časové okno: 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
|
|
Change in white blood cell count before and after the 6-week intervention
Časové okno: 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
Časové okno: 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
Časové okno: 0-6 weeks
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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
Časové okno: 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.
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0-6 weeks
|
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Change in plasma IL-6 before and after the 6-week intervention
Časové okno: 0-6 weeks
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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
Časové okno: 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
Časové okno: 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
Časové okno: 0-6 weeks
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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
Časové okno: 0-6 weeks
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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
Časové okno: 0-6 weeks
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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.
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0-6 weeks
|
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Change in PMA/Ionomysin induced INF-γ before and after the 6-week
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
11. února 2026
Primární dokončení (Odhadovaný)
31. prosince 2027
Dokončení studie (Odhadovaný)
31. prosince 2027
Termíny zápisu do studia
První předloženo
23. června 2026
První předloženo, které splnilo kritéria kontroly kvality
23. června 2026
První zveřejněno (Aktuální)
30. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
30. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
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