6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
23. juni 2026 opdateret af: 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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jonathan P Little, PhD
- Telefonnummer: 250-807-9876
- E-mail: jonathan.little@ubc.ca
Studiesteder
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V 1V7
- Rekruttering
- University of British Columbia Okanagan
-
Kontakt:
- Jonathan P Little, PhD
- Telefonnummer: 250-807-9876
- E-mail: jonathan.little@ubc.ca
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention
Tidsramme: 0-6 weeks
|
T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention.
|
0-6 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in CD4 expression before and after the 6-week intervention
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 0-6 weeks
|
The % of intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in % of non-classical monocytes before and after the 6-week intervention
Tidsramme: 0-6 weeks
|
The % of non-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 classical monocytes before and after the 6-week intervention
Tidsramme: 0-6 weeks
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 0-6 weeks
|
The monocyte count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in neutrophil count before and after the 6-week intervention
Tidsramme: 0-6 weeks
|
The neutrophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
|
0-6 weeks
|
|
Change in eosinophil count before and after the 6-week intervention
Tidsramme: 0-6 weeks
|
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
Tidsramme: 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
|
|
Change in plasma IL-10 before and after the 6-week intervention
Tidsramme: 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
Tidsramme: 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
|
|
Change in 4-h LPS-induced TNF-α before and after the 6-week intervention
Tidsramme: 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
|
|
Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention
Tidsramme: 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
|
|
Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention
Tidsramme: 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
|
|
Change in PMA/Ionomysin induced INF-γ before and after the 6-week
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
11. februar 2026
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
23. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juni 2026
Først opslået (Faktiske)
30. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H25-02870-chronic
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