- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06105697
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
20
Phase
- 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
-
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Balearic Islands
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Palma De Mallorca, Balearic Islands, Spain, 07122
- University of the Balearic Islands
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Palma De Mallorca, Balearic Islands, Spain, 07122
- Christian
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-
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
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 |
Intervention / Treatment |
|---|---|
|
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).
|
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).
|
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
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
|
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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
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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
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)
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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)
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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
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Muscle Soreness measured by a Wellness Questionary (1=Very sore; 2= Increase in soreness/ tightness; 3=Normal; 4=Feeling good; 5=Feeling great)
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Change from Baseline in Muscle Soreness at Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
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|
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
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Sleep Quality measured by a Wellness Questionary (1=Insomnia; 2=Restless sleep; 3=Difficulty falling asleep; 4=good; 5=Very restful)
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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)
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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)
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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.
Investigators
- 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)
October 1, 2023
Primary Completion (Actual)
November 1, 2023
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
October 23, 2023
First Submitted That Met QC Criteria
October 23, 2023
First Posted (Actual)
October 30, 2023
Study Record Updates
Last Update Posted (Actual)
October 21, 2024
Last Update Submitted That Met QC Criteria
October 17, 2024
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID 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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