Feasibility of Aerobic Exercise With Blood Flow Restriction Training in People Living With Type 2 Diabetes

NCT07196371 | Recruiting

• 1 other identifier: 2025-069
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Blood flow restriction; aerobic exercise; cardiorespiratory fitness; glycemia; feasability; physical activity; diabetes; continuious glucose monitor

Outcome Measures

Primary Outcomes (4)

• Rate of Recruitment

  Recruitment rate will be assessed as the number of individuals who inquire about the trial.

  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.

  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.

  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.

  Every 6 weeks up to 2 years

Secondary Outcomes (3)

• Cardiorespiratory Fitness (VO2max)

  6 Weeks

• Glycemia (CGM/HbA1c)

  6 Weeks

• Quality of Life (36-Item Short Form Health Survey (SF-36))

  6 Weeks

Study Arms (2)

Aerobic Training with Blood Flow Restriction

EXPERIMENTAL

Participants will perform aerobic training with blood flow restriction.

Behavioral: Aerobic Training with Blood Flow Restriction

Standard Aerobic Training

ACTIVE COMPARATOR

Participants will perform aerobic training.

Behavioral: Standard Aerobic Training

Interventions

Aerobic Training with Blood Flow Restriction BEHAVIORAL

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.

Aerobic Training with Blood Flow Restriction

Standard Aerobic Training BEHAVIORAL

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.

Standard Aerobic Training

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with type 2 diabetes (5.7% \< HbA1c \< 9.0%)
• Not regularly physically active (150 mins moderate-vigorous physical activity per week)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Brunswick: lead
• Diabetes Canada: collaborator
• University of Guelph: collaborator
• University of British Columbia: collaborator

Study Sites (3)

Exercise Metabolism and Inflammation Laboratory

Okanagan, British Columbia, Canada

NOT YET RECRUITING

Cardiometabolic Exercise & Lifestyle Laboratory

Fredericton, New Brunswick, E3B5A3, Canada

RECRUITING

Human Performance & Health Research Laboratory

Guelph, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Martin Senechal, PhD

  Cardiometabolic Exercise & Lifestyle Laboratory, Fredericton, New Brunswick

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Senechal, PhD

CONTACT

506-451-6889; martin.senechal@unb.ca

Jamie Burr, PhD

CONTACT

519-824-4120; burrj@uoguelph.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor and Acting Assistant Dean of Graduate Studies

Model Details: single-blind, multi-site, randomized controlled pilot trial

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: September 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CA (3)