Treadmill walking with blood flow restriction for people with type 2 diabetes
Testing the Feasibility of Blood Flow Restriction Training to Enhance the Health Benefits of Exercise in Individuals With Type 2 Diabetes: a Pilot Randomized Controlled Trial
This study will test whether adding blood flow restriction to treadmill walking for adults with type 2 diabetes improves cardiorespiratory fitness and blood sugar control compared with regular treadmill walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years to 64 Years |
| Sex | All |
| Sponsor | University of New Brunswick Academic / other |
| Locations | 3 sites (Okanagan, British Columbia and 2 other locations) |
| Trial ID | NCT07196371 on ClinicalTrials.gov |
What this trial studies
This is a single-blind, multi-site, randomized pilot comparing 6 weeks of supervised treadmill aerobic training with blood flow restriction (AT+BFR) versus standard treadmill aerobic training in people with type 2 diabetes. Sixty participants aged 19–64 with HbA1c between 5.7% and 9.0% will be randomized 1:1 across three Canadian sites and complete 96 minutes of treadmill walking per week for 6 weeks. Outcomes including cardiorespiratory fitness, measures of glycemia, and questionnaires will be collected at baseline and after 6 weeks to estimate feasibility and preliminary effect sizes. The protocol was informed by patients with lived experience and uses stratified randomization by sex and site.
Who should consider this trial
Good fit: Adults aged 19–64 with type 2 diabetes (HbA1c 5.7–9.0%) who are not regularly meeting 150 minutes per week of moderate-to-vigorous physical activity are the ideal candidates.
Not a fit: People with peripheral vascular disease, cardiovascular disease, anemia or other red blood cell disorders, unstable medications, or musculoskeletal issues preventing exercise are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could produce faster or larger improvements in fitness and blood sugar control than standard aerobic training.
How similar studies have performed: Emerging studies in healthy individuals suggest aerobic training plus blood flow restriction can speed fitness gains, but its safety and effectiveness in people with type 2 diabetes remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with type 2 diabetes (5.7% \< HbA1c \< 9.0%) * Not regularly physically active (150 mins moderate-vigorous physical activity per week) Exclusion Criteria: * 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 * 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
Where this trial is running
Okanagan, British Columbia and 2 other locations
- Exercise Metabolism and Inflammation Laboratory — Okanagan, British Columbia, Canada (Not_yet_recruiting)
- Cardiometabolic Exercise & Lifestyle Laboratory — Fredericton, New Brunswick, Canada (Recruiting)
- Human Performance & Health Research Laboratory — Guelph, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Martin Senechal, PhD — Cardiometabolic Exercise & Lifestyle Laboratory, Fredericton, New Brunswick
- Study coordinator: Martin Senechal, PhD
- Email: martin.senechal@unb.ca
- Phone: 506-451-6889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.