Effects of Aerobic Blood Flow Restriction

October 17, 2024 updated by: University of the Balearic Islands

Effect of Aerobic Blood Flow Restriction Training in Academy Football Players: A Randomised Controlled Trial

The aim is to evaluate the effects of aerobic blood flow restriction on academy football players. Randomized clinical trial, with two intervention groups: Experimental group I will carry out training based on running on the treadmill using blood flow restriction (BFR) on match days 4 and 3 pre-competition (MD-4, MD-3). On the other hand, the Experimental II group will perform the same training without the use of BFR for 6 weeks. The study will be carried out during the 2023-2024 season in the National and Youth Honor Divisions of Spanish soccer, with soccer teams from Mallorca Island. Before and after 6 weeks of intervention, the countermovement jump (CMJ), maximum aerobic speed (MAS), VO2max, and repeat sprint ability will be evaluated. The levels of muscle soreness (DOMS) will be evaluated at MD-4, MD-3, and MD-2. The same procedure will be carried out to evaluate muscle fatigue, sleep quality, and stress through a questionnaire. Sociodemographic and anthropometric data will be collected before starting the study. In addition, the rate of exertion perceived will be evaluated at MD-4, MD-3, and MD-2.

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

The warm-up will consist of federation Internationale football association (FIFA) 11+. 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.
20

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.

Study Contact Backup

Study Locations

  • Spain
    • Balearic Islands
      • Palma De Mallorca, Balearic Islands, Spain, 07122
        • University of the 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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-

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: Parallel Assignment
  • Masking: Quadruple

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 (Experimental I)
Running with Blood Flow Restriction on the treadmill for 4 sets of 5 minutes,1' interset rest using a periodization methodology in soccer (Match Day 4 and Match Day 3).
Other: Blood flow restriction Running on Treadmill
Soccer players included in experimental group I will carry out this program for 6 weeks, setting the blood pressure to ~ 60% of limb occlusion pressure (AOP). They will run for 4 sets of 5 minutes, separated by 1 minute of rest, at 50-60% of their maximum Aerobic Speed.
Experimental: Non-Blood flow restriction (Experimental II)
Running without Blood Flow Restriction on the treadmill for 4 sets of 5 minutes,1' interset rest using a periodization methodology in soccer (Match Day 4 and Match Day 3).
Other: Running on Treadmill
Soccer players included in experimental group II will carry out the program for 6 weeks without occlude the blood pressure. They will run for 4 sets of 5 minutes, separated by 1 minute of rest, at 50-60% of their maximum Aerobic Speed.

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 6 weeks
CMJ Test measured by Force Platform (Vald Performance, Brisbane, Australia)
Change from Baseline in countermovement Jump (CMJ Test) at 6 weeks
Change from Baseline in Treadmill Incremental Test
Time Frame: Change from Baseline in Maximum Aerobic Speed at 6 Weeks
Maximum Aerobic Speed (MAS) measured by the Treadmill Incremental test
Change from Baseline in Maximum Aerobic Speed at 6 Weeks
Change from Baseline in Repeat Sprint Ability
Time Frame: Change from Baseline in Repeat Sprint Ability at 6 Weeks
Repeat Sprint Ability measured by the Bangsbo Test
Change from Baseline in Repeat Sprint Ability at 6 Weeks
Change from Baseline In Yoyo Intermittent Recovery Test Level 1
Time Frame: Change from Baseline in Yoyo Intermittent Recovery Level 1 at 6 Weeks
Vo2max Indirect measured by the Yoyo Intermittent Recovery Test Level I
Change from Baseline in Yoyo Intermittent Recovery Level 1 at 6 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 Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
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 Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
Change from Baseline in Fatigue
Time Frame: Change from Baseline in Fatigue at Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
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 Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
Change from Baseline in Muscle Soreness
Time Frame: Change from Baseline in Muscle Soreness at Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
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 Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
Change from Baseline in Sleep Quality
Time Frame: Change from Baseline in Sleep Quality at Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
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 Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
Change from Baseline in Stress
Time Frame: Change from Baseline in Stress at Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
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 Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
Change from Baseline in Mood
Time Frame: Change from Baseline in Stress at Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
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 Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention

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.
  • Study Director: Natalia Romero Franco, PhD, University of the Balearic Islands
  • Principal Investigator: Christian Castilla López, MsC, University of the 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.
October 1, 2023

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 1, 2023

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 30, 2024

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 23, 2023

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 23, 2023

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 30, 2023

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.
October 21, 2024

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.
October 17, 2024

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.
November 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.
  • 361CER23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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