Physiological Outcomes of High-intensity Interval Training With Post-exercise Blood Flow Restriction

April 10, 2025 updated by: Stephen Burns, Nanyang Technological University

Physiological Outcomes of High-intensity Interval Training With Post-exercise Blood Flow

This research study revolves around the physiological outcomes of using post-exercise blood flow restriction (BFR) with high intensity short interval training (ST) The main aims of this study are to compare (i) aerobic performance outcomes, and (ii) anaerobic and muscular performance outcomes - between 2 groups of participants after either undergoing 3 weeks of ST + post-exercise BFR (BFR-ST) or traditional ST.

Study Overview

Status

Status

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

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

This research study revolves around the physiological outcomes of using post-exercise blood flow restriction (BFR) with high-intensity interval exercise training (HIIT), specifically high intensity short interval training (ST) protocol of 30s work, 30s rest, for the recreational endurance athlete. In previous research, it has been shown that using BFR during rest intervals of a ST protocol would elicit greater physiological stresses in terms of higher heart rate, greater muscle activation, reduced oxygenation within the muscle tissue during exercise, and increased blood lactate post-exercise as compared with the control condition. However, the physiological outcomes of this type of training method over a longer-term (9 sessions over 3 weeks) have not been explored. The main aims of this study is to compare the physiological outcomes, - (i) aerobic performance outcomes, and (ii) anaerobic and muscular performance outcomes - between 2 groups of participants after either undergoing 3 weeks of ST + post-exercise BFR (BFR-ST) or traditional ST . The hypotheses for this study are: the BFR-ST group would experience a (i) greater improvement in maximal aerobic capacity, function and time trial performance and, (ii) greater improvement in anaerobic power and capacity as well as muscular strength and power, as compared with the ST group.

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 (Actual)

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.
40

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

  • Singapore
      • Singapore, Singapore, 637616
        • Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University

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

Yes

Description

Inclusion Criteria:

  • Male
  • 18-40 years
  • Actively performing endurance exercise (running or cycling) for at least 2 sessions (1 - 1.5h) per week
  • Healthy (free from illnesses) and no musculoskeletal injuries for the past 6 months
  • No history of cardiometabolic, vascular diseases or similar conditions (e.g., high blood pressure, peripheral vascular diseases, heart diseases, metabolic syndrome, diabetes, stroke, etc.).
  • Pass the pre-participation health screening tests - Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and Australian Institute of Sport Blood Flow Restriction (AIS BFR) pre-screening questionnaire (no history of any risk factors).
  • Achieve a maximum oxygen uptake (VO2max) of ≥40ml/kg/min during a maximal aerobic power cycling screening test.
  • Non-smoker
  • Drink alcohol less than 3 times each week and less than 3 drinks each time

Exclusion Criteria:

  • Persons with any form of illnesses and/or musculoskeletal injuries for the past 6 months
  • Any history of cardiometabolic, vascular diseases or similar conditions which may worsen with the use of blood flow restriction during exercise
  • Fail the pre-participation health screening tests
  • Below 40ml/kg/min VO2max during maximal aerobic power cycling test
  • Smoker
  • Consumption of alcohol beyond that stated in the inclusion criteria.
  • History of asthma or taking medication for asthma.

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: Single

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: Blood flow restriction with short interval training (BFR-ST)
9 sessions of high intensity short interval training with blood flow restriction.
Other: BFR-ST
Undergo 9 sessions of high intensity short interval training involving 3 sets of 8-10 repetitions of 30 secs interval cycling and 30 secs recovery at 100-110% of maximal aerobic power. In between sets there will be 3 mins of passive rest. Blood flow restriction will be applied for 2 mins during the passive rest at 80% of limb occlusion pressure.
Sham Comparator: Sham altitude with short interval training (ST)
9 sessions of high intensity short interval training in an altitude chamber.
Other: ST
Undergo 9 sessions of high intensity short interval training involving 3 sets of 8-10 repetitions of 30 secs interval cycling and 30 secs recovery at 100-110% of maximal aerobic power. In between sets there will be 3 mins of passive rest. Cycling will be conducted in an environmental chamber and participants informed that the altitude is set to 2500m - actual altitude will be sea level.

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
Maximum oxygen uptake and power
Time Frame: Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
20 km Cycling time trial
Time Frame: Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
Wingate test of anaerobic power
Time Frame: Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
Peak and mean power and rate of fatigue
Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)

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
Exercise economy
Time Frame: Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
Oxygen uptake at a fixed load of 50% of maximum aerobic power
Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
Isometric mid-thigh pull
Time Frame: Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
Maximal strength assessment of lower body
Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
Countermovement jump height
Time Frame: Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)
Vertical jump height assessment
Will be assessed at baseline (Day 0 - Pre) and the change in this outcome 24 hours after 9 sessions of training over 3 weeks (Post)

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.
Nanyang Technological University

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.
July 1, 2023

Primary Completion (Actual)

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.
September 30, 2024

Study Completion (Actual)

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.
September 30, 2024

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).
April 5, 2023

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.
April 18, 2023

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.
April 28, 2023

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.
April 13, 2025

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.
April 10, 2025

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.
April 1, 2025

More Information

Terms related to this study

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.
  • IRB-2023-235

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All published data will be placed into the Data Repository of Nanyang Technological University National Institute of Education for public access upon publication.

IPD Sharing Time Frame

Upon publication - permanent repository

IPD Sharing Access Criteria

Public repository - exact web address available upon publication.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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