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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06105697
Other study ID # 361CER23
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date June 30, 2024

Study information

Verified date November 2023
Source University of the Balearic Islands
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date June 30, 2024
Est. primary completion date November 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 15 Years to 25 Years
Eligibility Inclusion Criteria: - Exclusion Criteria: - No injuries players

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.
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.

Locations

Country Name City State
Spain Christian Palma De Mallorca Balearic Islands
Spain University of the Balearic Islands Palma De Mallorca Balearic Islands

Sponsors (1)

Lead Sponsor Collaborator
University of the Balearic Islands

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Countermovement Jump (CMJ) CMJ Test measured by Force Platform (Vald Performance, Brisbane, Australia) Change from Baseline in countermovement Jump (CMJ Test) at 6 weeks
Primary Change from Baseline in Treadmill Incremental Test Maximum Aerobic Speed (MAS) measured by the Treadmill Incremental test Change from Baseline in Maximum Aerobic Speed at 6 Weeks
Primary Change from Baseline in Repeat Sprint Ability Repeat Sprint Ability measured by the Bangsbo Test Change from Baseline in Repeat Sprint Ability at 6 Weeks
Primary Change from Baseline In Yoyo Intermittent Recovery Test Level 1 Vo2max Indirect measured by the Yoyo Intermittent Recovery Test Level I Change from Baseline in Yoyo Intermittent Recovery Level 1 at 6 Weeks
Secondary Change from Baseline in Rating of Perceived Exertion (RPE) 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
Secondary Change from Baseline in Fatigue 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
Secondary Change from Baseline in Muscle Soreness 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
Secondary Change from Baseline in Sleep Quality 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
Secondary Change from Baseline in Stress 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
Secondary Change from Baseline in Mood 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
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