Aerobic ExerciseNCT06105697
Effects of Aerobic Blood Flow Restriction
A study testing Blood flow restriction Running on Treadmill and Running on Treadmill in people with Aerobic Exercise and Blood Flow Restriction Therapy, run by University of the Balearic Islands at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 15 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aerobic Exercise, Blood Flow Restriction Therapy
- What is being tested?
- Blood flow restriction Running on Treadmill and Running on Treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Oct 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- -
Who cannot join
- No injuries players
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Christian
Palma de Mallorca, Balearic Islands, 07122
University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
About this study
Official title: 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.
Read the 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.
- Conditions
- Aerobic Exercise, Blood Flow Restriction Therapy
- Being tested
- Blood flow restriction Running on Treadmill, Running on Treadmill
- Keywords
- Blood Flow Restriction, Aerobic Capacity, Soccer, Repeat Sprint Ability, Countermovement Jump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction Running on TreadmillOther
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.
Running on TreadmillOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Running on Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Countermovement Jump (CMJ)
CMJ Test measured by Force Platform (Vald Performance, Brisbane, Australia)
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline in Yoyo Intermittent Recovery Level 1 at 6 Weeks
Secondary outcomes (6)
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)
Measured: 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
Fatigue measured by a Wellness Questionary (1= Always tired; 2=More tired than normal; 3=Normal; 4= Fresh; 5= Very fresh)
Measured: 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
Muscle Soreness measured by a Wellness Questionary (1=Very sore; 2= Increase in soreness/ tightness; 3=Normal; 4=Feeling good; 5=Feeling great)
Measured: 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
Sleep Quality measured by a Wellness Questionary (1=Insomnia; 2=Restless sleep; 3=Difficulty falling asleep; 4=good; 5=Very restful)
Measured: 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
Stress measured by a Wellness Questionary (1=Highly stressed; 2=Feeling stressed; 3=Normal; 4=Relaxed; 5=Very relaxed)
Measured: 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
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)
Measured: Change from Baseline in Stress at Match Day -4 (MD-4), MD-3, MD-2 during the 6 Weeks´ Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Nov 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Romero Franco, PhD, Study director, University of the Balearic IslandsChristian Castilla López, MsC, Principal investigator, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105697
- Sponsor's protocol ID
- 361CER23
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Blood Flow Restriction Training in Academy Football Players: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06105697
- Acronym / sponsor ID
- 361CER23
- Conditions
- Aerobic Exercise, Blood Flow Restriction Therapy
- Keywords
- Blood Flow Restriction, Aerobic Capacity, Soccer, Repeat Sprint Ability, Countermovement Jump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction (Experimental I) | Experimental | Other: Blood flow restriction Running on TreadmillRunning 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). |
| Non-Blood flow restriction (Experimental II) | Experimental | Other: Running on TreadmillRunning 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). |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- No injuries players
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction Running on TreadmillSoccer 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 | Blood flow restriction (Experimental I) |
| Running on TreadmillSoccer 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. | Other | Non-Blood flow restriction (Experimental II) |
Primary outcome
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 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 Repeat Sprint Ability
Time frame: Change from Baseline in Repeat Sprint Ability at 6 Weeks
Repeat Sprint Ability measured by the Bangsbo Test
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Romero Franco, PhD study director
University of the Balearic Islands
Christian Castilla López, MsC principal investigator
University of the Balearic Islands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction Running on Treadmill and Running on Treadmill in people with Aerobic Exercise and Blood Flow Restriction Therapy, run by University of the Balearic Islands at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Countermovement Jump (CMJ) (time frame: Change from Baseline in countermovement Jump (CMJ Test) at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.