Feasibility of Aerobic Exercise With Blood Flow Restriction Training in People Living With Type 2 Diabetes
NCT ID: NCT07196371
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2026-01-01
2028-12-31
Brief Summary
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The main questions it aims to answer are:
Is 6 weeks of treadmill walking with blood flow restriction reasonable for people with type 2 diabetes to perform? Does treadmill walking with blood flow restriction training help manage type 2 diabetes better than just treadmill walking?
Researchers will compare treadmill walking with blood flow restriction to treadmill walking without blood flow restriction to see if blood flow restriction works to manage type 2 diabetes based on fitness and blood sugar levels.
Participants will:
Perform treadmill walking with or without blood flow restriction for 96 minutes a week for 6 weeks.
Visit the lab before and after the exercise for tests and questionnaires.
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Detailed Description
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Therefore, the primary objective of this study is to test the feasibility of a 6-week AT+BFR training intervention in individuals with T2D. The secondary objective is to establish preliminary effect sizes for the efficacy of AT+BFR training in individuals with T2D compared to the standard care AT (AT- stdCare).
Methods: This study is a single-blind (investigator \& statistical analyst), multi-site, randomized controlled pilot trial of a novel AT+BFR training intervention for individuals living with T2D, which has been informed by patients with lived experience. Participants will be randomized 1:1 using variable permuted block sizes (stratified by sex and site) into 1) AT+BFR or 2) AT-stdCare groups with outcome measures assessed at baseline and 6 weeks.
Population: In 3 sites across Canada, 60 (n=20 per site) individuals living with T2D (5.7% \< HbA1c \< 9.0%) aged 19-64 years, not meeting the physical activity guidelines (150 mins moderate-vigorous physical activity per week) will be recruited to participate in this 6-week pilot trial.
Intervention: Participants will perform supervised AT+BFR 3 times weekly for 32 minutes per session. A blood pressure cuff will be set between 60-80% of limb arterial occlusion with AT for 96 minutes per week of treadmill walking performed at 40-50% of heart rate reserve (HRR).
Participants in the AT-stdCare will perform 96 minutes per week of treadmill walking at 40-50% of HRR following the same schedule as AT+BFR, training 3 times per week for 32 minutes per session.
Outcomes: The main outcome measures will pertain to the feasibility of a larger trial and include recruitment rates, enrollment and adherence to the intervention, and retention for follow-up testing. The secondary outcomes will be focused on establishing effect sizes to power a larger trial. Effect sizes for the change in cardiorespiratory fitness and continuous glucose monitoring (CGM) outcomes will be determined to help select and power a primary outcome for a more definitive trial of AT+BFR.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Aerobic Training with Blood Flow Restriction
Participants will perform aerobic training with blood flow restriction.
Aerobic Training with Blood Flow Restriction
Participants will undergo a 6-week aerobic training intervention with blood flow restriction applied to the lower limbs.
Blood flow restriction will be applied using a blood pressure cuff set between 60-80% of limb arterial occlusion pressure.
Training will consist of treadmill walking at 40-50% of heart rate reserve (HRR) for 32 minutes per session, 3 times per week for a total of 96 minutes per week.
Standard Aerobic Training
Participants will perform aerobic training.
Standard Aerobic Training
Participants will follow the same aerobic training protocol as the AT+BFR group but without blood flow restriction.
Training will consist of treadmill walking at 40-50% of HRR for 32 minutes per session, 3 times per week for a total of 96 minutes per week.
Interventions
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Aerobic Training with Blood Flow Restriction
Participants will undergo a 6-week aerobic training intervention with blood flow restriction applied to the lower limbs.
Blood flow restriction will be applied using a blood pressure cuff set between 60-80% of limb arterial occlusion pressure.
Training will consist of treadmill walking at 40-50% of heart rate reserve (HRR) for 32 minutes per session, 3 times per week for a total of 96 minutes per week.
Standard Aerobic Training
Participants will follow the same aerobic training protocol as the AT+BFR group but without blood flow restriction.
Training will consist of treadmill walking at 40-50% of HRR for 32 minutes per session, 3 times per week for a total of 96 minutes per week.
Eligibility Criteria
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Inclusion Criteria
* Not regularly physically active (150 mins moderate-vigorous physical activity per week)
Exclusion Criteria
* Unstable medications over the last 3 months
* Absolute contraindications to BFR (i.e. peripheral vascular disease)
* A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions
* A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis)
* Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely
* Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity
19 Years
64 Years
ALL
No
Sponsors
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Diabetes Canada
OTHER
University of Guelph
OTHER
University of British Columbia
OTHER
University of New Brunswick
OTHER
Responsible Party
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Martin Senechal
Full Professor and Acting Assistant Dean of Graduate Studies
Principal Investigators
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Martin Senechal, PhD
Role: PRINCIPAL_INVESTIGATOR
Cardiometabolic Exercise & Lifestyle Laboratory, Fredericton, New Brunswick
Locations
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Exercise Metabolism and Inflammation Laboratory
Okanagan, British Columbia, Canada
Cardiometabolic Exercise & Lifestyle Laboratory
Fredericton, New Brunswick, Canada
Human Performance & Health Research Laboratory
Guelph, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-069
Identifier Type: -
Identifier Source: org_study_id
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