Blood Flow Restriction and Recovery in Soccer Players

March 30, 2023 updated by: University of the Balearic Islands

Effects of Blood Flow Restriction on Post-competition Recovery on Semi-professional and Youth Soccer Players

The objective is to evaluate the effects of blood flow restriction training on the post-competition recovery of professional and semi-professional soccer players. Randomized crossover clinical trial, with two intervention groups: Experimental group I will carry out a recovery training based on the use of the blood flow restriction (BFR) on day 1 post-competition. On the other hand, the Experimental II group will perform the same recovery training without the use of BFR. After 1 month the groups will cross their intervention and make the recovery with the opposite method to the initial one. The study will be carried out during the 2021-2022 season, from first regional to third division of Spanish soccer, with soccer teams from the Mallorca Island. Before the competition, the countermovement jump (CMJ) will be evaluated and repeated at 0, 24, and 72 h after the competition. The levels of muscle soreness (DOMS) will be evaluated pre-post-competition 0, 24, 48 and 72h later. The same procedure will be carried out to evaluate muscle fatigue, sleep quality, and stress through a questionnaire that athletes will fill out pre, 0, 24, 48 and 72h after the game. Sociodemographic and anthropometric data will be collected before starting the study.

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

W-UP:

The warm-up will consist of 5 minutes running slow, 5 minutes mobility, and 5 minutes of running exercises. In addition, the warm-up will contain a familiarization with the jump test.

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 Locations

  • Spain
    • Balearic Islands
      • Palma De Mallorca, Balearic Islands, Spain, 07122
        • Christian

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

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 50 Minutes or more playing during the last match.

Exclusion Criteria:

  • No injuries players.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover 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 recovery (Experimental I)
Active recovery program with blood flow restriction using a periodization methodology in soccer. (Post-match +1 training).
Device: Blood flow restriction recovery
Soccer players included in experimental group I will carry out this program for 1 week setting the blood pressure to ~ 60% of limb occlusion pressure (LOP). After a month they will carry out the program without restriction of blood flow. Which will consist of a warm-up part with continuous running (5 min), 6 sprints from box to box of the field at 60-70% of a maximum repetition, and an activation part in the form of rounds with the ball.
Experimental: Non-Blood flow restriction recovery (Experimental II)
Active recovery program without blood flow restriction using a periodization methodology in soccer. (Post-match +1 training).
Other: Active recovery
Soccer players included in experimental group II will carry out this program for 1 week. After a month they will carry out the program with blood flow restriction. Which will consist of a warm-up part with continuous running (5 min), 6 sprints from box to box of the field at 60-70% of a maximum repetition, and an activation part in the form of rounds with the ball.

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 from Baseline in Countermovement Jump (CMJ)
Time Frame: Change from Baseline in countermovement Jump (CMJ Test) at 0 hours, 24 hours, 72 hours and 4 weeks
CMJ Test measured by Force Platform (Vald Performance, Brisbane, QLD)
Change from Baseline in countermovement Jump (CMJ Test) at 0 hours, 24 hours, 72 hours and 4 weeks

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
Change from Baseline in Rating of Perceived Exertion (RPE)
Time Frame: Change from Baseline in RPE at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Rating of Perceived Exertion (RPE) measured by Borg scale (0=Rest; 1=Really easy; 2=easy; 3=moderate; 4=sort of hard; 5=hard; 6=hard; 7=Really hard; 8= Really hard; 9= Really, really, hard; 10= Maximal)
Change from Baseline in RPE at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Change from Baseline in Fatigue
Time Frame: Change from Baseline in Fatigue at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Fatigue measured by a Wellness Questionary (1= Always tired; 2=More tired than normal; 3=Normal; 4= Fresh; 5= Very fresh)
Change from Baseline in Fatigue at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Change from Baseline in Muscle Soreness
Time Frame: Change from Baseline in Muscle Soreness at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Muscle Soreness measured by a Wellness Questionary (1=Very sore; 2= Increase in soreness/ tightness; 3=Normal; 4=Feeling good; 5=Feeling great)
Change from Baseline in Muscle Soreness at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Change from Baseline in Sleep Quality
Time Frame: Change from Baseline in Sleep Quality at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Sleep Quality measured by a Wellness Questionary (1=Insomnia; 2=Restless sleep; 3=Difficulty falling asleep; 4=good; 5=Very restful)
Change from Baseline in Sleep Quality at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Change from Baseline in Stress
Time Frame: Change from Baseline in Stress at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Stress measured by a Wellness Questionary (1=Highly stressed; 2=Feeling stressed; 3=Normal; 4=Relaxed; 5=Very relaxed)
Change from Baseline in Stress at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Change from Baseline in Mood
Time Frame: Change from Baseline in Stress at 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
Mood measured by a Wellness Questionary (1=Highly annoyed / irritable / down; 2=Snappy with team-mates, family and friends; 3=Less interested in others / activities; 4=Generally good mood; 5=Very positive mood)
Change from Baseline in Stress at 0 hours, 24 hours, 48 hours, 72 hours and 4 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.
University of the Balearic Islands

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: Christian Castilla López, University of Balearic Islands
  • Study Director: Natalia Romero Franco, PhD, University of Balearic Islands

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.
November 1, 2021

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.
November 30, 2021

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.
June 1, 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).
October 5, 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.
October 25, 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.
October 27, 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 3, 2023

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.
March 30, 2023

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.
March 1, 2023

More Information

Terms related to this study

Keywords

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.
  • 221CER21

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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