NCT05835544

Brief Summary

The study aims to look at the blood flow restriction (BFR) + high intensity interval training (HIIT) variables to induce an optimal acute training stimulus (i.e., acute responses in main outcome measures of muscular activation, muscular deoxygenation, and secondary outcome measures of heart rate (HR), blood lactate (bLa), subjective ratings of perceived exertion and discomfort) The hypotheses for this study are: (i) BFR increases muscular deoxygenation, muscular activation when HIIT exercise is of the same intensity, (ii) however, comparing between a lower BFR + HIIT exercise intensity (e.g. 80% V̇O2max) and higher HIIT exercise intensity (e.g. 100% V̇O2max), muscular deoxygenation and activation will be similar but HR will be lower in the BFR + HIIT condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 5, 2023

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Heart rate

    Heart rate using short-range telemetry

    Measured and compared between each acute arm (condition)

  • Blood lactate concentration

    Fingertip capillary measure

    Measured and compared between each acute arm (condition)

  • Muscle activation

    Surface electromyography of the vastus lateralis and biceps femoris muscles to determine electrical activity of the motor units (physiological parameter)

    Measured and compared between each acute arm (condition)

  • Muscle oxygenation

    Near infra-red spectroscopy to examine regional tissue (the vastus lateralis muscle) oxygenation i.e, the percentage of haemoglobin and deoxyhaemoglobin (physiological parameter)

    Measured and compared between each acute arm (condition)

Secondary Outcomes (2)

  • Rating of perceived exertion

    Measured and compared between each acute arm (condition)

  • Exertion and Pain scale

    Measured and compared between each acute arm (condition)

Study Arms (4)

HIIT Control

ACTIVE COMPARATOR

High intensity interval cycling

Other: Active Comparator: HIIT Control

HIIT + BFR between cycling sets

EXPERIMENTAL

High intensity interval cycling with blood flow restriction applied between sets of cycling

Other: Experimental: HIIT + BFR between cycling sets

HIIT + BFR moderate occlusion during cycling

EXPERIMENTAL

High intensity interval cycling with moderate blood flow restriction applied during cycling

Other: Experimental: HIIT + BFR moderate occlusion during cycling

HIIT + BFR high occlusion during cycling

EXPERIMENTAL

High intensity interval cycling with high blood flow restriction applied during cycling

Other: Experimental: HIIT + BFR high occlusion during cycling

Interventions

Complete 3 sets of five repetitions of 30 seconds cycling at 100% of maximal aerobic power with 30 seconds of active unloaded recovery between repetitions; 3 minutes of passive rest between sets.

HIIT Control

Complete 3 sets of five repetitions of 30 seconds cycling at 100% of maximal aerobic power with 30 seconds of active unloaded recovery between repetitions; 3 minutes of passive rest between sets. Blood flow restriction is applied for 2 minutes during the passive rest at 80% of limb occlusion pressure.

HIIT + BFR between cycling sets

Complete 3 sets of five repetitions of 30 seconds cycling at 70% of maximal aerobic power with 30 seconds of active unloaded recovery between repetitions; 3 minutes of passive rest between sets. Blood flow restriction is applied during and between exercise repetitions at 50% of limb occlusion pressure and deflated during passive rest periods.

HIIT + BFR moderate occlusion during cycling

Complete 3 sets of five repetitions of 30 seconds cycling at 70% of maximal aerobic power with 30 seconds of active unloaded recovery between repetitions; 3 minutes of passive rest between sets. Blood flow restriction is applied during and between exercise repetitions at 80% of limb occlusion pressure and deflated during passive rest periods.

HIIT + BFR high occlusion during cycling

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age: 18-40 years
  • Competed in competitive varsity sports (endurance, tennis, badminton, squash, football, basketball, etc.) at the varsity/club level
  • Actively training 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 (high blood pressure, peripheral vascular diseases, heart diseases, metabolic syndrome, diabetes, stroke, etc.).
  • Pass pre-participation health screening tests - Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) and Australian Institute of Sport (AIS) Blood Flow Restriction (BFR) pre-screening questionnaire (no history of any risk factors).
  • Maximal oxygen uptake (VO2max) of ≥40mmol/min/kg during a maximal aerobic cycling test.
  • Non-smoker
  • Drink alcohol less than 3 times each week and less than 3 drinks each time

You may not qualify if:

  • Any diagnosed form of cardiometabolic disease (CVD, diabetes, metabolic syndrome, hypertension)
  • Any symptoms contraindication of exercise testing (eg chest pains)
  • Any balance or dizziness problems
  • Any chronic medical conditions (whether medicated or not)
  • Any bone joint problems
  • Any Physician diagnosed contraindications to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University

Singapore, 637616, Singapore

Location

Related Publications (1)

  • Chua M, Sim A, Burns SF. Acute physiological and perceptual responses to three blood flow restricted interval exercise protocols: a randomised controlled trial. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-13. doi: 10.1139/apnm-2024-0423.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stephen Burns, PhD

    Nanyang Technological University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 28, 2023

Study Start

August 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
ANALYTIC CODE
Time Frame
Upon publication - permanent repository
Access Criteria
Public repository - exact web address available upon publication.
More information

Locations