NCT06105697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 21, 2024

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

October 23, 2023

Last Update Submit

October 17, 2024

Conditions

Keywords

Blood Flow RestrictionAerobic CapacitySoccerRepeat Sprint AbilityCountermovement Jump

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Blood flow restriction (Experimental I)

EXPERIMENTAL

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

Non-Blood flow restriction (Experimental II)

EXPERIMENTAL

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

Interventions

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.

Blood flow restriction (Experimental I)

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.

Non-Blood flow restriction (Experimental II)

Eligibility Criteria

Age15 Years - 25 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • No injuries players

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Christian

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

Study Officials

  • Natalia Romero Franco, PhD

    University of the Balearic Islands

    STUDY DIRECTOR
  • Christian Castilla López, MsC

    University of the Balearic Islands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 30, 2023

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

June 30, 2024

Last Updated

October 21, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations