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.
Diagnosed with type 2 diabetes (5.7% < HbA1c < 9.0%)
Not regularly physically active (150 mins moderate-vigorous physical activity per week)
Musculoskeletal issues preventing exercise training
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
Parallel
Aerobic Training with Blood Flow Restriction
BehavioralParticipants 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
BehavioralParticipants 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.
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.
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.
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.
Cardiorespiratory Fitness (VO2max)
Establishing effect size to power future trials (VO2max)
Glycemia (CGM/HbA1c)
Establishing effect size to power future trials (CGM/HbA1c)
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.
Click on the lead sponsor to view all of their trials.
University of New Brunswick
Lead sponsor
Diabetes Canada
Collaborator
University of Guelph
Collaborator
University of British Columbia
Collaborator
