Type 2 DiabetesBOOST-HEALTHNCT07196371
Feasibility of Aerobic Exercise With Blood Flow Restriction Training in People Living With Type 2 Diabetes
A study testing Aerobic Training with Blood Flow Restriction and Standard Aerobic Training in people with Type 2 Diabetes, run by University of New Brunswick at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Aerobic Training with Blood Flow Restriction and Standard Aerobic Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with type 2 diabetes (5.7% < HbA1c < 9.0%)
- Not regularly physically active (150 mins moderate-vigorous physical activity per week)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Cardiometabolic Exercise & Lifestyle Laboratory
Fredericton, New Brunswick, E3B5A3
Martin Senechal, PhD, 506-451-6889, martin.senechal@unb.ca
Martin Senechal, PhD
- Recruiting
Human Performance & Health Research Laboratory
Guelph, Ontario
Jamie Burr, PhD, 519-824-4120 ext. 52591, burrj@uoguelph.ca
Jamie Burr, PhD
- Not yet recruiting
Exercise Metabolism and Inflammation Laboratory
Okanagan, British Columbia
Jonathan Little, PhD, 250-807-9876, jonathan.little@ubc.ca
Jonathan Little, PhD
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Aerobic Training with Blood Flow Restriction, Standard Aerobic Training
- Keywords
- Blood flow restriction, aerobic exercise, cardiorespiratory fitness, glycemia, feasability, physical activity, diabetes, continuious glucose monitor
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Training with Blood Flow RestrictionBehavioural
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.
Standard Aerobic TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Training with Blood Flow Restriction | Experimental | Participants will perform aerobic training with blood flow restriction. Receives: Behavioral: Aerobic Training with Blood Flow Restriction |
| Standard Aerobic Training | Active comparator | Participants will perform aerobic training. Receives: Behavioral: Standard Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Recruitment
Recruitment rate will be assessed as the number of individuals who inquire about the trial.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Every 6 weeks up to 2 years
Secondary outcomes (3)
Cardiorespiratory Fitness (VO2max)
Establishing effect size to power future trials (VO2max)
Measured: 6 Weeks
Glycemia (CGM/HbA1c)
Establishing effect size to power future trials (CGM/HbA1c)
Measured: 6 Weeks
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.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blind, multi-site, randomized controlled pilot trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Canada, University of Guelph, University of British Columbia
- Responsible party
- Principal investigator, Martin Senechal, University of New Brunswick
- Investigators
- Martin Senechal, PhD, Principal investigator, Cardiometabolic Exercise & Lifestyle Laboratory, Fredericton, New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196371
- Sponsor's protocol ID
- 2025-069
- Acronym
- BOOST-HEALTH
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07196371
- Acronym / sponsor ID
- BOOST-HEALTH / 2025-069
- Conditions
- Type 2 Diabetes
- Keywords
- Blood flow restriction, aerobic exercise, cardiorespiratory fitness, glycemia, feasability, physical activity, diabetes, continuious glucose monitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- Diabetes Canada, University of Guelph, University of British Columbia
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single-blind, multi-site, randomized controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training with Blood Flow Restriction | Experimental | Behavioral: Aerobic Training with Blood Flow RestrictionParticipants will perform aerobic training with blood flow restriction. |
| Standard Aerobic Training | Active comparator | Behavioral: Standard Aerobic TrainingParticipants will perform aerobic training. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with type 2 diabetes (5.7% < HbA1c < 9.0%)
- Not regularly physically active (150 mins moderate-vigorous physical activity per week)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Training with Blood Flow RestrictionParticipants 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. | Behavioural | Aerobic Training with Blood Flow Restriction |
| Standard Aerobic TrainingParticipants 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. | Behavioural | Standard Aerobic Training |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Cardiorespiratory Fitness (VO2max)
Time frame: 6 Weeks
Glycemia (CGM/HbA1c)
Time frame: 6 Weeks
Quality of Life (36-Item Short Form Health Survey (SF-36))
Time frame: 6 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Senechal, PhD principal investigator
Cardiometabolic Exercise & Lifestyle Laboratory, Fredericton, New Brunswick
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training with Blood Flow Restriction and Standard Aerobic Training in people with Type 2 Diabetes, run by University of New Brunswick at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Senechal, PhD (506-451-6889, martin.senechal@unb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Recruitment (time frame: Every 4 weeks up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.