6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
23 de junho de 2026 atualizado 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.
Visão geral do estudo
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Jonathan P Little, PhD
- Número de telefone: 250-807-9876
- E-mail: jonathan.little@ubc.ca
Locais de estudo
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British Columbia
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Kelowna, British Columbia, Canadá, V1V 1V7
- Recrutamento
- University of British Columbia Okanagan
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Contato:
- Jonathan P Little, PhD
- Número de telefone: 250-807-9876
- E-mail: jonathan.little@ubc.ca
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in CD4 expression before and after the 6-week intervention
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
11 de fevereiro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
23 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de junho de 2026
Primeira postagem (Real)
30 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H25-02870-chronic
Plano para dados de participantes individuais (IPD)
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