NCT05037942

Brief Summary

Blood flow restriction (BFR) exercise involves the application of a constriction device to the limbs to restrict muscle blood flow during exercise. In recent years, BFR has become increasingly popular due to its additive effects on low-load resistance training, often promoting greater increases in muscle strength and size compared to similar resistance training without BFR. However, like other exercise, it is possible that BFR exercise can cause exercise-induced muscle damage (EIMD) that results in short-term reductions in muscle function and increased muscle soreness and swelling. One major variable that may influence the onset of EIMD is the restriction pressure used to restrict blood flow; however, the influence of restriction pressure on resistance EIMD is unclear. The purpose of this study is to investigate effects of two different restriction pressures (low and high) on EIMD responses to a bout of low-load BFR resistance exercise in a sample of healthy, active adults. It is hypothesised that a higher restriction pressure will result in increased EIMD compared to a lower restriction pressure. To test this hypothesis, participants will perform a lower-body exercise protocol with and without BFR, and several markers of EIMD will be assessed before and immediately, 24, 48, and 72 hours after the exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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

First Submitted

Initial submission to the registry

August 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 29, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

August 31, 2021

Last Update Submit

December 18, 2023

Conditions

Keywords

Muscle DamageMuscle SorenessMuscle StrengthBlood Flow Restriction

Outcome Measures

Primary Outcomes (1)

  • Mean change in maximal voluntary isometric force of the knee extensors from pre-intervention up to 72 hours post-intervention

    The change in the maximum amount of voluntary isometric force produced by the knee extensors, assessed via a series of maximal voluntary contractions performed at 90 degrees of knee flexion (extension = 0 degrees).

    Immediately pre-intervention, immediately post-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention

Secondary Outcomes (5)

  • Mean change in the joint angle-torque curve of the knee extensors from pre-intervention up to 72 hours post-intervention

    Immediately pre-intervention, immediately post-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention

  • Mean change in plasma creatine kinase from pre-intervention up to 72 hours post-intervention

    Immediately pre-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention

  • Mean change in pain-free range of motion of the knee extensors from pre-intervention up to 72 hours post-intervention

    Immediately pre-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention

  • Mean change in muscle thickness of the rectus femoris and vastus lateralis from pre-intervention up to 72 hours post-intervention

    Immediately pre-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention

  • Mean change in perceived muscle soreness from pre-intervention up to 72 hours post-intervention

    Immediately pre-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention

Study Arms (4)

Blood flow-restricted exercise at 40% limb occlusion pressure (BFR-40)

EXPERIMENTAL

Participants in BFR-40 will perform a lower-body exercise protocol under BFR set to 40% of the participants' relative limb occlusion pressure.

Other: Blood flow restriction at 40% limb occlusion pressure

Blood flow-restricted exercise at 80% limb occlusion pressure (BFR-80)

EXPERIMENTAL

Participants in BFR-80 will perform the same lower-body BFR exercise protocol as BFR-40; however, the occlusion pressure will be set to 80% of the participants' relative limb occlusion pressure.

Other: Blood flow restriction at 80% limb occlusion pressure

Control for BFR-40

NO INTERVENTION

Participants randomised to BFR-40 will perform the same exercise protocol without BFR with the contralateral leg.

Control for BFR-80

NO INTERVENTION

Participants randomised to BFR-80 will perform the same exercise protocol without BFR with the contralateral leg.

Interventions

A 13-cm-wide pneumatic cuff will be applied to the most proximal portion of the chosen thigh (as determined by randomisation), immediately distal to the inguinal fold, prior to a bout of lower-body resistance exercise. The cuff will be inflated to 40% of limb occlusion pressure pressure and will remain inflated throughout the exercise (total occlusion time: \~5 mins).

Also known as: Vascular restriction, Vascular occlusion, Venous restriction
Blood flow-restricted exercise at 40% limb occlusion pressure (BFR-40)

A 13-cm-wide pneumatic cuff will be applied to the most proximal portion of the chosen thigh (as determined by randomisation), immediately distal to the inguinal fold, prior to a bout of lower-body resistance exercise. The cuff will be inflated to 80% of limb occlusion pressure pressure and will remain inflated throughout the exercise (total occlusion time: \~5 mins).

Also known as: Vascular restriction, Vascular occlusion, Venous restriction
Blood flow-restricted exercise at 80% limb occlusion pressure (BFR-80)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreationally active (defined as performing ≥ 150 minutes of moderate-intensity or ≥ 75 minutes of vigorous-intensity exercise per week for the past 6 months)
  • Resistance-untrained (defined as performing less than 2 resistance exercise sessions per week for the past 6 months)

You may not qualify if:

  • Any history of cardiovascular (including hypertension \[diastolic \> 90 and/or systolic blood pressure \> 140 mmHg\] and peripheral arterial vascular disease), metabolic, respiratory (including severe asthma), haematological (including deep vein thrombosis and pulmonary embolism), neurological, gastrointestinal, kidney, liver, or musculoskeletal disease
  • Current or previous musculoskeletal injury that may be aggravated by exercise
  • Current smoker
  • Recently used prescribed anti-inflammatory medication within the previous 1 month
  • Self-reported or diagnosed menstrual irregularities within ≥ 3 months prior to recruitment
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

Related Publications (4)

  • Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.

    PMID: 31156448BACKGROUND
  • Lixandrao ME, Ugrinowitsch C, Berton R, Vechin FC, Conceicao MS, Damas F, Libardi CA, Roschel H. Magnitude of Muscle Strength and Mass Adaptations Between High-Load Resistance Training Versus Low-Load Resistance Training Associated with Blood-Flow Restriction: A Systematic Review and Meta-Analysis. Sports Med. 2018 Feb;48(2):361-378. doi: 10.1007/s40279-017-0795-y.

    PMID: 29043659BACKGROUND
  • de Queiros VS, Dos Santos IK, Almeida-Neto PF, Dantas M, de Franca IM, Vieira WHB, Neto GR, Dantas PMS, Cabral BGAT. Effect of resistance training with blood flow restriction on muscle damage markers in adults: A systematic review. PLoS One. 2021 Jun 18;16(6):e0253521. doi: 10.1371/journal.pone.0253521. eCollection 2021.

    PMID: 34143837BACKGROUND
  • Hyldahl RD, Hubal MJ. Lengthening our perspective: morphological, cellular, and molecular responses to eccentric exercise. Muscle Nerve. 2014 Feb;49(2):155-70. doi: 10.1002/mus.24077. Epub 2013 Dec 3.

    PMID: 24030935BACKGROUND

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kyle Gapper

    University of Surrey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Given the perceptual response that occurs under different occlusion pressures, it is difficult to mask the participant to the experimental conditions. Efforts will be made to minimise detection bias by blinding the outcome assessor to the study conditions and the timepoints from which the data has been collected.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The study uses a within-between, unilateral design, in which participants will be randomly allocated into one of two experimental groups using a stratified random allocation technique. Each group will perform blood flow-restricted exercise with one leg and the same exercise protocol without BFR with the contralateral leg. Experimental groups will be differentiated by the tourniquet pressure used during the BFR condition: i) tourniquet pressure set to 40% of limb occlusion pressure or ii) tourniquet pressure set to 80% of limb occlusion pressure. Legs will be counterbalanced such that the BFR and control conditions in each study group contain an equal number of dominant and non-dominant legs. This study design allows comparison between the two experimental conditions (i.e., 40% vs. 80% limb occlusion pressure), while allowing participants to serve as their own control condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 8, 2021

Study Start

November 29, 2021

Primary Completion

June 28, 2022

Study Completion

June 28, 2022

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Data spreadsheet will be available upon request from the principle investigator.

Locations