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The Effects of Restriction Pressure on Muscle Damage Responses to Blood Flow Restriction Exercise

Primary Purpose

Muscle Damage, Muscle Soreness, Muscle Strength

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Blood flow restriction at 40% limb occlusion pressure
Blood flow restriction at 80% limb occlusion pressure
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Damage focused on measuring Muscle Damage, Muscle Soreness, Muscle Strength, Blood Flow Restriction

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • University of SurreyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

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

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

Control for BFR-40

Control for BFR-80

Arm Description

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

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.

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Mean change in the joint angle-torque curve of the knee extensors from pre-intervention up to 72 hours post-intervention
The change in the joint angle-torque curve of the knee extensors, assessed using a series of maximal isokinetic contractions performed from 90 to 0 degrees of knee flexion at an angular velocity of 45 degrees per second.
Mean change in plasma creatine kinase from pre-intervention up to 72 hours post-intervention
The change in plasma creatine kinase assessed via a commercially-available assay kit.
Mean change in pain-free range of motion of the knee extensors from pre-intervention up to 72 hours post-intervention
"Pain-free range of motion of the knee extensors" describes the degree of passive knee flexion the participant can achieve until they reach a point of self-perceived soreness. The assessment involves the investigator progressively moving the shank of the participant into further knee flexion until the participant experiences noticeable discomfort, at which the knee joint angle will be measured using a goniometer.
Mean change in muscle thickness of the rectus femoris and vastus lateralis from pre-intervention up to 72 hours post-intervention
The change in muscle thickness of the rectus femoris and vastus lateralis when measured using B-mode ultrasound at 50 percent total femur length. Muscle thickness will be defined as the mean perpendicular distance between the deep and superficial aponeuroses at the proximal, central, and distal portions of the acquired images.
Mean change in perceived muscle soreness from pre-intervention up to 72 hours post-intervention
The change in perceived lower-body muscle soreness when assessed at rest and during voluntary flexion and extension of the knee. Soreness at rest and during motion will be quantified separately using a 100 mm visual analogue scale titled "Visual Analogue Scale for Muscle Soreness". Participants will be asked to mark their perceived soreness at any point along a horizonal line ranging from 0 mm (no soreness at all) to 100 mm (most soreness ever experienced). Scores will be rounded to the nearest 1 mm.

Full Information

First Posted
August 31, 2021
Last Updated
January 7, 2022
Sponsor
University of Surrey
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1. Study Identification

Unique Protocol Identification Number
NCT05037942
Brief Title
The Effects of Restriction Pressure on Muscle Damage Responses to Blood Flow Restriction Exercise
Official Title
The Influence of Restriction Pressure on Indices of Exercise-Induced Muscle Damage Following Low-Load Blood Flow-Restricted Resistance Exercise: A Randomised Controlled Trial in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Surrey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Following screening for the inclusion and exclusion criteria of the study, eligible participants will be fully informed of the study purposes and procedures and written consent will be acquired. During this study, participants will be randomly allocated into one of two experimental groups, with each group performing blood flow-restricted knee extension 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. Several indirect markers of EIMD will be assessed at baseline and 24, 48, and 72 hours after the exercise bout. Additional neuromuscular assessments will be performed immediately post-exercise to provide insight into the fatiguability of the exercise protocol. Participants will be required to attend the laboratory on five separate occasions: one visit for screening, assessment of limb occlusion pressure (i.e., the lowest pressure required to occlude blood flow to the limb), and familiarisation of the exercise protocol and neuromuscular assessments, one visit for completion of the exercise protocol and baseline/post-exercise tests, and three follow-up visits. All participants will be asked to refrain from alcohol and exercise from 24 hours prior to the exercise trial up to their final visit. The consumption of any pain-relieving medications (e.g., anti-inflammatory drugs) and undergoing of any muscle damage treatments (e.g., massage) will be prohibited throughout the study. To minimise the effects of pre-exercise feeding on the outcome measures, visits will be scheduled for the morning and participants will attend the lab following an overnight fast of a minimum of 10 hours, although water may be consumed ad libitum. All post-exercise measures will be collected at the same time of day ± 1 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Damage, Muscle Soreness, Muscle Strength
Keywords
Muscle Damage, Muscle Soreness, Muscle Strength, Blood Flow Restriction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood flow-restricted exercise at 40% limb occlusion pressure (BFR-40)
Arm Type
Experimental
Arm Description
Participants in BFR-40 will perform a lower-body exercise protocol under BFR set to 40% of the participants' relative limb occlusion pressure.
Arm Title
Blood flow-restricted exercise at 80% limb occlusion pressure (BFR-80)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control for BFR-40
Arm Type
No Intervention
Arm Description
Participants randomised to BFR-40 will perform the same exercise protocol without BFR with the contralateral leg.
Arm Title
Control for BFR-80
Arm Type
No Intervention
Arm Description
Participants randomised to BFR-80 will perform the same exercise protocol without BFR with the contralateral leg.
Intervention Type
Other
Intervention Name(s)
Blood flow restriction at 40% limb occlusion pressure
Other Intervention Name(s)
Vascular restriction, Vascular occlusion, Venous restriction
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Blood flow restriction at 80% limb occlusion pressure
Other Intervention Name(s)
Vascular restriction, Vascular occlusion, Venous restriction
Intervention Description
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).
Primary Outcome Measure Information:
Title
Mean change in maximal voluntary isometric force of the knee extensors from pre-intervention up to 72 hours post-intervention
Description
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).
Time Frame
Immediately pre-intervention, immediately post-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention
Secondary Outcome Measure Information:
Title
Mean change in the joint angle-torque curve of the knee extensors from pre-intervention up to 72 hours post-intervention
Description
The change in the joint angle-torque curve of the knee extensors, assessed using a series of maximal isokinetic contractions performed from 90 to 0 degrees of knee flexion at an angular velocity of 45 degrees per second.
Time Frame
Immediately pre-intervention, immediately post-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention
Title
Mean change in plasma creatine kinase from pre-intervention up to 72 hours post-intervention
Description
The change in plasma creatine kinase assessed via a commercially-available assay kit.
Time Frame
Immediately pre-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention
Title
Mean change in pain-free range of motion of the knee extensors from pre-intervention up to 72 hours post-intervention
Description
"Pain-free range of motion of the knee extensors" describes the degree of passive knee flexion the participant can achieve until they reach a point of self-perceived soreness. The assessment involves the investigator progressively moving the shank of the participant into further knee flexion until the participant experiences noticeable discomfort, at which the knee joint angle will be measured using a goniometer.
Time Frame
Immediately pre-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention
Title
Mean change in muscle thickness of the rectus femoris and vastus lateralis from pre-intervention up to 72 hours post-intervention
Description
The change in muscle thickness of the rectus femoris and vastus lateralis when measured using B-mode ultrasound at 50 percent total femur length. Muscle thickness will be defined as the mean perpendicular distance between the deep and superficial aponeuroses at the proximal, central, and distal portions of the acquired images.
Time Frame
Immediately pre-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention
Title
Mean change in perceived muscle soreness from pre-intervention up to 72 hours post-intervention
Description
The change in perceived lower-body muscle soreness when assessed at rest and during voluntary flexion and extension of the knee. Soreness at rest and during motion will be quantified separately using a 100 mm visual analogue scale titled "Visual Analogue Scale for Muscle Soreness". Participants will be asked to mark their perceived soreness at any point along a horizonal line ranging from 0 mm (no soreness at all) to 100 mm (most soreness ever experienced). Scores will be rounded to the nearest 1 mm.
Time Frame
Immediately pre-intervention, 24 hours post-intervention, 48 hours post-intervention, 72 hours post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyle Gapper
Phone
+44 (0)1483 689400
Email
k.gapper@surrey.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Hunt
Phone
+44 (0)1483 689400
Email
j.hunt@surrey.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Gapper
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Surrey
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle Gapper
Phone
+44 (0)1483 689400
Email
k.gapper@surrey.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data spreadsheet will be available upon request from the principle investigator.
Citations:
PubMed Identifier
31156448
Citation
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. Erratum In: Front Physiol. 2019 Oct 22;10:1332.
Results Reference
background
PubMed Identifier
29043659
Citation
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.
Results Reference
background
PubMed Identifier
34143837
Citation
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.
Results Reference
background
PubMed Identifier
24030935
Citation
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.
Results Reference
background

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The Effects of Restriction Pressure on Muscle Damage Responses to Blood Flow Restriction Exercise

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