6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
23 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jonathan P Little, PhD
- Número de teléfono: 250-807-9876
- Correo electrónico: jonathan.little@ubc.ca
Ubicaciones de estudio
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British Columbia
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Kelowna, British Columbia, Canadá, V1V 1V7
- Reclutamiento
- University of British Columbia Okanagan
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Contacto:
- Jonathan P Little, PhD
- Número de teléfono: 250-807-9876
- Correo electrónico: jonathan.little@ubc.ca
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention
Periodo de tiempo: 0-6 weeks
|
T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention.
|
0-6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in CD4 expression before and after the 6-week intervention
Periodo de tiempo: 0-6 weeks
|
The CD4 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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Change in CD8 expression before and after the 6-week intervention
Periodo de tiempo: 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.
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Change in % of T regulatory cells before and after the 6-week intervention
Periodo de tiempo: 0-6 weeks
|
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
Periodo de tiempo: 0-6 weeks
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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
Periodo de tiempo: The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
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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
Periodo de tiempo: 0-6 weeks
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The % Th17 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
|
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Change in CD66b+ expression before and after the 6-week intervention
Periodo de tiempo: The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
|
0-6 weeks
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The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
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Change in CD11b+ expression before and after the 6-week intervention
Periodo de tiempo: 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.
|
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Change in CD63+ expression before and after the 6-week intervention
Periodo de tiempo: 0-6 weeks
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The CD63+ 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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Change in % of classical monocytes before and after the 6-week intervention
Periodo de tiempo: 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
Periodo de tiempo: 0-6 weeks
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 0-6 weeks
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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
|
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Change in white blood cell count before and after the 6-week intervention
Periodo de tiempo: 0-6 weeks
|
The white blood cell 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 monocyte count before and after the 6-week intervention
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 0-6 weeks
|
The eosinophil 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 plasma IL-6 before and after the 6-week intervention
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 0-6 weeks
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 0-6 weeks
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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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de febrero de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
23 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de junio de 2026
Publicado por primera vez (Actual)
30 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 2
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Ejercicio
Otros números de identificación del estudio
- H25-02870-chronic
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .