6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 19 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of 6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics in Adults withT2D
Overview
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.
Detailed description
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.
Interventions
- Other Exercise
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
Primary outcome measures
- Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention [Time frame: 0-6 weeks]
Secondary outcome measures (12)
- Change in CD4 expression before and after the 6-week intervention [Time frame: 0-6 weeks]
- Change in CD8 expression before and after the 6-week intervention [Time frame: 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 [Time frame: 0-6 weeks]
- Change in % of Th1 cells before and after the 6-week intervention [Time frame: 0-6 weeks]
- Change in % of Th2 cells before and after the 6-week intervention [Time frame: 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 [Time frame: 0-6 weeks]
- Change in CD66b+ expression before and after the 6-week intervention [Time frame: 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 [Time frame: 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 [Time frame: 0-6 weeks]
- Change in % of classical monocytes before and after the 6-week intervention [Time frame: 0-6 weeks]
- Change in % of intermediate monocytes before and after the 6-week intervention [Time frame: 0-6 weeks]
- Change in % of non-classical monocytes before and after the 6-week intervention [Time frame: 0-6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Canada · 1 center
- University of British Columbia Okanagan — Kelowna
Identifiers
NCT: NCT07676305 · H25-02870-chronic