An interventional study of Aerobic Training with Blood Flow Restriction and Standard Aerobic Training in Type 2 Diabetes, sponsored by University of New Brunswick. Recruiting at 3 sites in Canada. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by University of New Brunswick · Not applicable, Interventional, and Other
The goal of this trial is to learn if blood flow restriction training with treadmill walking is possible for individuals living with type 2 diabetes. It will also learn about how the blood flow restriction with treadmill walking could improve health.
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.
Individuals with type 2 diabetes (T2D) display reduced cardiorespiratory fitness, which is a strong predictor of premature mortality and T2D-related complications. Aerobic training (AT) enhances cardiorespiratory fitness and is considered a cornerstone in the management and treatment of T2D. Emerging data suggest that AT combined with blood flow restriction (AT+BFR) training, could potentially enhance cardiorespiratory fitness faster than typical AT in healthy individuals. However, the feasibility of AT+BFR in individuals with T2D and its impact on cardiorespiratory fitness have yet to be determined.
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.
Exclusion Criteria:
Participants will perform aerobic training with blood flow restriction.
Behavioral: Aerobic Training with Blood Flow Restriction
Participants will perform aerobic training.
Behavioral: Standard Aerobic Training
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.
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.
Rate of Recruitment
Recruitment rate will be assessed as the number of individuals who inquire about the trial.
Time frame: Every 4 weeks up to 2 years
Rate of Enrollment
Enrollment rate will be assessed as the number of eligible participants who consent to participate in the trial and are randomized to one of the two study arms out of the total number of eligible individuals recruited.
Time frame: Every 4 weeks up to 2 years
Adherence to the Intervention
Adherence to the intervention will be assessed as the number of sessions that the participant attended out of the total number of sessions.
Time frame: From enrollment to the end of intervention at week 6
Rate of Retention for Follow-Up Testing
Retention rate will be assessed as the number of participants who complete follow-up testing measurements six weeks after randomization.
Time frame: Every 6 weeks up to 2 years
Cardiorespiratory Fitness (VO2max)
Establishing effect size to power future trials (VO2max)
Time frame: 6 Weeks
Glycemia (CGM/HbA1c)
Establishing effect size to power future trials (CGM/HbA1c)
Time frame: 6 Weeks
Quality of Life (36-Item Short Form Health Survey (SF-36))
Establishing effect size to power future trials (SF-36). Scores range from 0-100 for eight domains of health, with higher scores indicating better health-related quality of life and lower scores indicating poorer health-related quality of life.
Time frame: 6 Weeks
Plan to share: Undecided
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University of New Brunswick