Effects of Aerobic Blood Flow Restriction

Sponsor
University of the Balearic Islands (Other)
Overall Status
Recruiting
CT.gov ID
NCT06105697
Collaborator
(none)
40
2
2
9
20
2.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Blood flow restriction Running on Treadmill
  • Other: Running on Treadmill
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Aerobic Blood Flow Restriction Training in Academy Football Players: A Randomised Controlled Trial
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Blood flow restriction (Experimental I)

Running with Blood Flow Restriction on the treadmill for 4 sets of 5 minutes,1'30" interset rest using a periodization methodology in soccer (Match Day 4 and Match Day 3).

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 and 30 seconds of rest, at 45-55% 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,1'30" 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 and 30 seconds of rest, at 45-55% of their maximum Aerobic Speed.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in Countermovement Jump (CMJ) [Change from Baseline in countermovement Jump (CMJ Test) at 6 weeks]

    CMJ Test measured by Force Platform (Vald Performance, Brisbane, Australia)

  2. Change from Baseline in Treadmill Incremental Test [Change from Baseline in Maximum Aerobic Speed at 6 Weeks]

    Maximum Aerobic Speed (MAS) measured by the Treadmill Incremental test

  3. Change from Baseline in Repeat Sprint Ability [Change from Baseline in Repeat Sprint Ability at 6 Weeks]

    Repeat Sprint Ability measured by the Bangsbo Test

  4. Change from Baseline In Yoyo Intermittent Recovery Test Level 1 [Change from Baseline in Yoyo Intermittent Recovery Level 1 at 6 Weeks]

    Vo2max Indirect measured by the Yoyo Intermittent Recovery Test Level I

Secondary Outcome Measures

  1. Change from Baseline in Rating of Perceived Exertion (RPE) [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)

  2. Change from Baseline in Fatigue [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)

  3. Change from Baseline in Muscle Soreness [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)

  4. Change from Baseline in Sleep Quality [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)

  5. Change from Baseline in Stress [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)

  6. Change from Baseline in Mood [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 25 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Exclusion Criteria:
  • No injuries players

Contacts and Locations

Locations

Site City State Country Postal Code
1 Christian Palma De Mallorca Balearic Islands Spain 07122
2 University of the Balearic Islands Palma De Mallorca Balearic Islands Spain 07122

Sponsors and Collaborators

  • University of the Balearic Islands

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of the Balearic Islands
ClinicalTrials.gov Identifier:
NCT06105697
Other Study ID Numbers:
  • 361CER23
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 31, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of the Balearic Islands

Study Results

No Results Posted as of Oct 31, 2023