Feasibility of Aerobic Exercise With Blood Flow Restriction Training in People Living With Type 2 Diabetes (BOOST-HEALTH)

January 23, 2026 updated by: Martin Senechal, University of New Brunswick

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jamie Burr, PhD
  • Phone Number: ext 52591 519-824-4120
  • Email: burrj@uoguelph.ca

Study Locations

  • Canada
    • British Columbia
      • Okanagan, British Columbia, Canada
        • Not yet recruiting
        • Exercise Metabolism and Inflammation Laboratory
        • Contact:
        • Principal Investigator:
          • Jonathan Little, PhD
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B5A3
        • Recruiting
        • Cardiometabolic Exercise & Lifestyle Laboratory
        • Contact:
        • Principal Investigator:
          • Martin Senechal, PhD
    • Ontario
      • Guelph, Ontario, Canada
        • Recruiting
        • Human Performance & Health Research Laboratory
        • Contact:
        • Principal Investigator:
          • Jamie Burr, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic Training with Blood Flow Restriction
Participants will perform aerobic training with blood flow restriction.
Behavioral: Aerobic Training with Blood Flow Restriction

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.
Active Comparator: Standard Aerobic Training
Participants will perform aerobic training.
Behavioral: Standard Aerobic Training

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Recruitment
Time Frame: Every 4 weeks up to 2 years
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
Time Frame: Every 4 weeks up to 2 years
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
Time Frame: From enrollment to the end of intervention at week 6
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
Time Frame: Every 6 weeks up to 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory Fitness (VO2max)
Time Frame: 6 Weeks
Establishing effect size to power future trials (VO2max)
6 Weeks
Glycemia (CGM/HbA1c)
Time Frame: 6 Weeks
Establishing effect size to power future trials (CGM/HbA1c)
6 Weeks
Quality of Life (36-Item Short Form Health Survey (SF-36))
Time Frame: 6 Weeks
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.
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Brunswick

Collaborators

University of British Columbia
University of Guelph
Diabetes Canada

Investigators

  • Principal Investigator: Martin Senechal, PhD, Cardiometabolic Exercise & Lifestyle Laboratory, Fredericton, New Brunswick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

September 19, 2025

First Posted (Actual)

September 29, 2025

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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