6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
23. juni 2026 oppdatert av: 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.
Studieoversikt
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jonathan P Little, PhD
- Telefonnummer: 250-807-9876
- E-post: jonathan.little@ubc.ca
Studiesteder
-
-
British Columbia
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Kelowna, British Columbia, Canada, V1V 1V7
- Rekruttering
- University of British Columbia Okanagan
-
Ta kontakt med:
- Jonathan P Little, PhD
- Telefonnummer: 250-807-9876
- E-post: jonathan.little@ubc.ca
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
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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
|
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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
|
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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
|
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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
|
Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. februar 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
23. juni 2026
Først innsendt som oppfylte QC-kriteriene
23. juni 2026
Først lagt ut (Faktiske)
30. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H25-02870-chronic
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