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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05097027
Other study ID # 221CER21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date June 1, 2022

Study information

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

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 1, 2022
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 14 Years to 40 Years
Eligibility Inclusion Criteria: - 50 Minutes or more playing during the last match. Exclusion Criteria: - No injuries players.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Spain Christian 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, QLD) Change from Baseline in countermovement Jump (CMJ Test) at 0 hours, 24 hours, 72 hours and 4 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 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
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 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
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 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
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 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
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 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
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 0 hours, 24 hours, 48 hours, 72 hours and 4 weeks
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