Blood Flow Restriction During High-intensity Interval Exercise

April 17, 2021 updated by: Shazlin Shaharudin, Universiti Sains Malaysia

The Effects of Blood Flow Restriction During High-intensity Interval Exercise Among Healthy Adult Males: a Randomized Controlled Trial

The study is a randomized controlled trial aimed to compare the effects of blood flow restriction (BFR) in different phases (i.e., exercise versus interval) during high-intensity interval exercise (HIIE) on aerobic capacity, anaerobic capacity, isokinetic knee strength, lower limb biomechanics during single-leg landing and cycling economy among healthy adult males. Participants were randomized to three groups. Intervention was conducted for 12 weeks with 2 sessions per week. During intervention, all groups conducted HIEE on cycle ergometer with or without BFR. Assessments were conducted before the intervention, on the 6th week of intervention and after the intervention. Assessments included physical characteristics, aerobic and anaerobic capacity, lower limb biomechanics during single-leg landing and isokinetic knee strength.

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

The study is a randomized controlled trial aimed to compare the effects of blood flow restriction (BFR) in different phases (i.e., exercise versus interval) during high-intensity interval exercise on aerobic capacity, anaerobic capacity, isokinetic knee strength, lower limb biomechanics during single-leg landing and cycling economy among healthy adult males. The procedure of the study has been approved by Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/20060331) and complied with the Declaration of Helsinki. participants were randomised into one of the following conditions: 1. High-intensity interval exercise without BFR (C Group). 2. High-intensity interval exercise with BFR during exercise phase (E Group). 3 High-intensity interval exercise with BFR during interval phase (I Group). After obtaining the participants' written informed consent form, participants proceeded to pre-intervention tests. Each exercise test needs to be separated by at least 24 hours (First day: VO2max; Second day: Cycling economy; Third day: Isokinetic knee strength and Wingate tests). In the sixth week and after the twelfth week of the exercise intervention, the participants took part in the mid-test and post-test, which was similar protocol in the pre-test. The duration of the intervention is 12 weeks, with two sessions per week. Each exercise session took about an hour and monitored by an exercise physiologist. Exercise intervention comprised of cycle exercises using a cycle ergometer device. First, participants performed a 5-minute warm-up activity (50W). After the warm-up, each group sprinted with 85% VO2max for 3 minutes, where the rotation speed should be maintained at around 60 revolutions per minute (RPM) and then rests for 3 minutes on the ergometer without cycling. Then, they sprinted again after the first break and this sequence of sprint and rest were repeated three times. The 85% of VO2max was determined based on the results from the VO2max test. Exercise (E) Group and Interval (I) Group completed the training with an air cuff placed at the inguinal fold of both legs in sequence in order to provide partial blood flow restriction. The sequence of wrapping was done in random order, but both thighs were wrapped twice in a single intervention session. E Group applied 40% LOP BFR during exercise; I Group I applied 40% LOP BFR during passive rest i.e., interval. On the other hand, C group does not perform BFR during the whole process. Two-factor repeated measures analysis of variance (pre-, mid-and post-intervention time points x three groups) was used to examine the main effects and interaction effects of changes for each tested variables following intervention. If the main effects or interaction effects are significant, the Newman-Keuls post hoc test was applied for multiple comparisons.

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 (Anticipated)

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.
33

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.
  • Name: Shazlin Shaharudin, PhD
  • Phone Number: +601124222894
  • Email: shazlin@usm.my

Study Contact Backup

Study Locations

  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Recruiting
        • Universiti Sains Malaysia
        • Contact:
          • Shazlin Shaharudin
          • Phone Number: +601124222894
          • Email: shazlin@usm.my
        • Contact:
          • Mohd Bazlan Mukrim
          • Phone Number: 09-767 2354
          • Email: bazlan@usm.my
        • Principal Investigator:
          • Shazlin Shaharudin, PhD
        • Sub-Investigator:
          • Shuoqi Li, MSc

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

20 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy male adults.
  2. Age between 20-25.
  3. Have normal body mass index (BMI).
  4. Physically active (i.e., exercise regularly for at least three times per week) and total score more than 600MET-min/week based on The International Physical Activity Questionnaire (IPAQ).
  5. VO2max value above 42 ml/kg/min during cycling test (Above fair VO2max level)(American College of Sports Medicine, 2010).

Exclusion Criteria:

  1. BMI is greater than 25kg/m2.
  2. Have exercise-related disorders such as coronary heart disease, peripheral vascular diseases, rhabdomyolysis, respiratory inflammation, or have neurological disorders.
  3. Have implanted electrical devices.
  4. Have significant cognitive impairment.

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

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: HIE with BFR during exercise phase
BFR with 40% Arterial occlusive pressure cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each time during exercise
Other: Exercise with blood flow restriction (BFR)
All participants completed high-intensity interval exercise plus (1) BFR applied during exercise phase, or (2) BFR applied during interval phase, or (3) no BFR applied.
ACTIVE_COMPARATOR: HIE with BFR during interval phase
BFR with 40% Arterial occlusive pressure cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each during the interval
Other: Exercise with blood flow restriction (BFR)
All participants completed high-intensity interval exercise plus (1) BFR applied during exercise phase, or (2) BFR applied during interval phase, or (3) no BFR applied.
NO_INTERVENTION: HIE without BFR
Cycling at 85% VO2max for 3 minutes and rest interval for 3 minutes (4 sets) each time during exercise

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 of aerobic capacity from baseline to post-intervention
Time Frame: 12 weeks
Maximum oxygen consumption was measured during Astrand protocol
12 weeks
Change of anaerobic capacity from baseline to post-intervention
Time Frame: 12 weeks
Maximum power was measured during Wingate test protocol
12 weeks
Change of muscular strength from baseline to post-intervention
Time Frame: 12 weeks
The strength of the thigh muscle groups was measured using isokinetic device
12 weeks
Change of knee joint moments from baseline to post-intervention
Time Frame: 12 weeks
Biomechanical data measured during single-leg landing test
12 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.
Universiti Sains Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shazlin Shaharudin, Universiti Sains Malaysia

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.
April 1, 2021

Primary Completion (ANTICIPATED)

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, 2021

Study Completion (ANTICIPATED)

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.
March 31, 2022

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 15, 2021

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 17, 2021

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 22, 2021

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 22, 2021

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 17, 2021

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, 2021

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.
  • USM/JEPeM/20060331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data in the experiment is anonymous and has been stored in SPSS software. Only researchers can view or extract data. Data were shown as grouped data and participants were not individually identified. The data must be password protected, and only the researcher can access all the data. Before taking the photos and wearing a gas collection mask, the researcher had to ask the participants' permission. The three-dimensional video recorded using Qualisys could not identify the respondent as it only captured the reflective marker number's trajectory on the respondent. Data will be published as scientific articles to be shared with other researchers.

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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