Aerobic Exercise with Blood Flow Restriction for Type 2 Diabetes

(BOOST-HEALTH Trial)

Not yet recruiting at 2 trial locations

Overseen By Jamie Burr, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of New Brunswick

Must not be taking: Heart rate affecting

Disqualifiers: Musculoskeletal issues, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether walking on a treadmill with blood flow restriction (temporarily reducing blood flow to muscles) can help people with type 2 diabetes manage their condition more effectively. The researchers aim to determine if this exercise, known as Aerobic Training with Blood Flow Restriction, is feasible and more beneficial than regular treadmill walking for improving fitness and blood sugar control. Participants will exercise for a total of 96 minutes each week for six weeks. The trial seeks individuals with type 2 diabetes who are not already engaging in regular, intense physical activity. As an unphased trial, it offers a unique opportunity to explore innovative exercise methods that could enhance diabetes management.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are on medications that affect heart rate monitoring, you may not be eligible to participate.

What prior data suggests that blood flow restriction training is safe for individuals with type 2 diabetes?

Research has shown that aerobic exercise with blood flow restriction (BFR) is generally safe for people with type 2 diabetes. Participants in studies experienced higher blood pressure during BFR exercises, but it stayed within safe levels, indicating good tolerance among those with type 2 diabetes. Additionally, no major difference in health outcomes appeared between those who exercised with BFR and those who did not over several months, suggesting both methods are similarly safe. Overall, these findings suggest that blood flow restriction training can be a safe option for managing type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about aerobic training with blood flow restriction for type 2 diabetes because it offers a novel twist on traditional exercise methods. While standard treatments often focus on medications and lifestyle changes like diet and regular aerobic exercise, this technique adds a unique element by restricting blood flow during workouts. This restriction can potentially enhance the benefits of exercise, improving muscle strength and insulin sensitivity even with lower intensity workouts. This means people with type 2 diabetes might achieve better results with less strain, making it a promising option for those who find conventional exercise challenging.

What evidence suggests that aerobic training with blood flow restriction is effective for managing type 2 diabetes?

Research has shown that aerobic exercise with blood flow restriction (BFR), which participants in this trial may receive, might benefit people with type 2 diabetes by improving fitness and controlling blood sugar levels. Studies have found that this exercise can enhance heart and lung health and build muscle, aiding diabetes management. One study found that BFR training might also improve overall health by lowering blood pressure and reducing obesity, crucial for those with type 2 diabetes. While not all studies show significant differences, early results suggest that adding BFR to aerobic exercise could offer extra benefits compared to regular aerobic exercise alone, which is another treatment arm in this trial. ^{2 3 4 5 6}

Who Is on the Research Team?

Martin Senechal, PhD

Principal Investigator

Cardiometabolic Exercise & Lifestyle Laboratory, Fredericton, New Brunswick

Are You a Good Fit for This Trial?

This trial is for individuals living with type 2 diabetes who are interested in participating in a 6-week exercise program. The study aims to include people willing to walk on a treadmill with or without blood flow restriction and complete lab visits for tests and questionnaires.

Inclusion Criteria

Not regularly physically active (less than 150 mins of moderate-vigorous physical activity per week)

I have type 2 diabetes with my HbA1c levels between 5.7% and 9.0%.

Exclusion Criteria

Unstable medications over the last 3 months

I have low iron levels or anemia, or I am being treated for these.

I have physical issues that stop me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform treadmill walking with or without blood flow restriction for 96 minutes a week for 6 weeks

6 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Follow-up testing measurements

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Training with Blood Flow Restriction

Trial Overview The study is testing the feasibility of aerobic exercise combined with blood flow restriction training compared to standard aerobic training alone. It will measure if this approach can better manage type 2 diabetes by improving fitness levels and regulating blood sugar.

How Is the Trial Designed?

Group I: Aerobic Training with Blood Flow Restriction Experimental Treatment 1 Intervention

Participants will perform aerobic training with blood flow restriction.

Group II: Standard Aerobic Training Active Control 1 Intervention

Participants will perform aerobic training.

Who Is Running the Clinical Trial?

University of New Brunswick

Lead Sponsor

Trials

25

Recruited

2,700+

University of Guelph

Collaborator

Trials

87

Recruited

15,100+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Diabetes Canada

Collaborator

Trials

13

Recruited

1,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11473333/

The effect of blood flow-restrictive resistance training on the ... BFR-RT could reduce the 10-year ASCVD risk in middle-aged T2DM patients for by improving metabolic abnormalities, BP and obesity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07196371

Feasibility of Aerobic Exercise With Blood Flow Restriction ... Emerging data suggest that AT combined with blood flow restriction (AT+BFR) training, could potentially enhance cardiorespiratory fitness ...

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1409267/full

Effect of blood flow-restrictive resistance training on ... There was no significant difference in all indicators between the two exercise groups at the baseline, third and sixth months of intervention (p > 0.05).

4. sciencedirect.com sciencedirect.com/science/article/pii/S1043276020302344

Effects of Blood Flow Restriction Exercise and Possible ... Blood Flow Restriction Combined with Aerobic Training​​ Walk training with BFR twice per day, 6 days per week for 3 weeks resulted in an increase of muscle mass ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2024/08020/acute_effects_of_blood_flow_restricted_aerobic.4.aspx

Acute effects of blood flow restricted aerobic exercise in... This study aimed to compare the acute effects of aerobic exercise performed with blood flow restriction (BFR), a novel method to increase exercise gains.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11296424/

Acute effects of blood flow restricted aerobic exercise in type 2 ... The higher blood pressure observed during the BFR exercise remained within safe limits. These results suggest that people with T2DM can safely ...