6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics

June 23, 2026 updated by: Jonathan Little, University of British Columbia

Impact of 6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics in Adults withT2D

To conduct a randomized control trial to determine the impact of 6-weeks of blood flow restriction training on immune cell function and bioenergetics in adults living with type 2 diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will be randomized to a regular treadmill walking group or treadmill walking with blood flow restriction (BFR) group for 6 weeks. In both groups participants will complete treadmill walking on 3 days per week for 6 weeks. During week 1 participants will walk for 21 minutes during each session which will be increased to 32 minutes for the remaining 5 weeks of the study. In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve. In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP). The cuffs will remain inflated for the entire session but will deflate for 1 minute every 10 minutes based on safety recommendations. The percentage of LOP will progressively increase over the course of the intervention. Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively. All outcomes will be assessed at baseline before randomization and at the end of the 6-week intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 1V7
        • Recruiting
        • University of British Columbia Okanagan
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

A. Aged 19-64 years. B. Diagnosed with type 2 diabetes with current HbA1c 5.7-9.0% C. Completing <150 minutes of moderate-vigorous physical activity per week.

Exclusion Criteria:

A. Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.

B. Unstable type 2 diabetes medication of the last 3 months C. Absolute contraindications to BFR (i.e., peripheral vascular disease) D. A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions E. A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis) F. Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely G. 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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treadmill walking with blood flow restriction
Treadmill walking with blood flow restriction performed 3 days per week for 6 weeks.
Other: Exercise
In both groups participants will complete treadmill walking on 3 days per week for 6 weeks. During the first week participants will walk continuously for 21 minutes during each training session which will be increased to 32 minutes per training session for weeks 2-6. In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve. In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP). The cuffs will remain inflated for the entire session but will deflate for 1 min every 10 min based on safety recommendations. The percentage of LOP will progressively increase over the course of the intervention. Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively.
Active Comparator: Treadmill Walking
Treadmill walking performed 3 days per week for 6 weeks.
Other: Exercise
In both groups participants will complete treadmill walking on 3 days per week for 6 weeks. During the first week participants will walk continuously for 21 minutes during each training session which will be increased to 32 minutes per training session for weeks 2-6. In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve. In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP). The cuffs will remain inflated for the entire session but will deflate for 1 min every 10 min based on safety recommendations. The percentage of LOP will progressively increase over the course of the intervention. Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention
Time Frame: 0-6 weeks
T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention.
0-6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in CD4 expression before and after the 6-week intervention
Time Frame: 0-6 weeks
The CD4 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in CD8 expression before and after the 6-week intervention
Time Frame: The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in % of T regulatory cells before and after the 6-week intervention
Time Frame: 0-6 weeks
The % T regulatory cells will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of Th1 cells before and after the 6-week intervention
Time Frame: 0-6 weeks
The % Th1 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of Th2 cells before and after the 6-week intervention
Time Frame: The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in % of Th17 cells before and after the 6-week intervention
Time Frame: 0-6 weeks
The % Th17 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in CD66b+ expression before and after the 6-week intervention
Time Frame: The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in CD11b+ expression before and after the 6-week intervention
Time Frame: The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in CD63+ expression before and after the 6-week intervention
Time Frame: 0-6 weeks
The CD63+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of classical monocytes before and after the 6-week intervention
Time Frame: 0-6 weeks
The % of classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of intermediate monocytes before and after the 6-week intervention
Time Frame: 0-6 weeks
The % of intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in % of non-classical monocytes before and after the 6-week intervention
Time Frame: 0-6 weeks
The % of non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in TLR-4 expression on classical monocytes before and after the 6-week intervention
Time Frame: 0-6 weeks
The TLR-4 expression on classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention
Time Frame: 0-6 weeks
The TLR-4 expression on intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention
Time Frame: 0-6 weeks
The TLR-4 expression on non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.
0-6 weeks
Change in white blood cell count before and after the 6-week intervention
Time Frame: 0-6 weeks
The white blood cell count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
0-6 weeks
Change in monocyte count before and after the 6-week intervention
Time Frame: 0-6 weeks
The monocyte count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
0-6 weeks
Change in neutrophil count before and after the 6-week intervention
Time Frame: 0-6 weeks
The neutrophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
0-6 weeks
Change in eosinophil count before and after the 6-week intervention
Time Frame: 0-6 weeks
The eosinophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.
0-6 weeks
Change in plasma IL-6 before and after the 6-week intervention
Time Frame: 0-6 weeks
The plasma IL-6 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
0-6 weeks
Change in plasma IL-10 before and after the 6-week intervention
Time Frame: 0-6 weeks
The plasma IL-10 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
0-6 weeks
Change in plasma TNF-α before and after the 6-week intervention
Time Frame: 0-6 weeks
The plasma TNF-α concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.
0-6 weeks
Change in 4-h LPS-induced TNF-α before and after the 6-week intervention
Time Frame: 0-6 weeks
The LPS-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.
0-6 weeks
Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention
Time Frame: 0-6 weeks
The LPS+IL10-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.
0-6 weeks
Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention
Time Frame: 0-6 weeks
The CD3/CD28 stimulated INF-γ concentration will be measured from T-cell culture supernatant using an ELISA at baseline and after the 6-week intervention.
0-6 weeks
Change in PMA/Ionomysin induced INF-γ before and after the 6-week
Time Frame: 0-6 weeks
The PMA/Ionomysin induced INF-γ concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.
0-6 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H25-02870-chronic

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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