Vascular OcclusionNCT05452109
Effect of Blood Flow Restriction on Football-Related Performance Parameters
A study testing Blood Flow Restriction and Classical Training Alone in people with Vascular Occlusion and Soccer, run by Biruni University at 2 sites in Turkey (Türkiye).
Trial summary
The blood flow restriction method can have similar or superior effects to high-intensity exercises even in a short duration, which can positively affect some performance parameters, can be applied with low-intensity load and cause hypertrophy in the muscle by providing high metabolic stress, facilitating muscle growth… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Occlusion, Soccer, Exercise
- What is being tested?
- Blood Flow Restriction and Classical Training Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Dec 2022to 27 Oct 2023
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a male between the ages of 18-30 years
- Volunteer to participate in the study
- Playing football in one of the clubs in Istanbul for at least 1 year
- Being in the pre-season of the club
- Absence of any ongoing musculoskeletal problems that limit exercising
Who cannot join
- Having at least one of the contraindications preventing the application of blood flow restriction (Smoking, previous venous thromboembolism, risk of peripheral vascular disease (ankle-brachial index <0.9), coronary heart disease, hypertension, hemophilia, etc.).
- History of sports injury in the last 6 months
- Orthopedic lower extremity surgery in the last 1 year
- Body mass index ≥ 30 kg/m2
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Biruni University
Istanbul
Istanbul University Cerrahpasa
Istanbul
About this study
Official title: Improvement of Football-Related Performance Parameters: Application of Blood Flow Restrictive Exercise
The blood flow restriction method can have similar or superior effects to high-intensity exercises even in a short duration, which can positively affect some performance parameters, can be applied with low-intensity load and cause hypertrophy in the muscle by providing high metabolic stress, facilitating muscle growth without significantly changing the total training dose. The aim of this study is to investigate whether adding the blood flow restriction method to the classical training program can be more effective than the classical training applied alone in the development of football-related performance parameters.
- Conditions
- Vascular Occlusion, Soccer, Exercise, EMG
- Being tested
- Blood Flow Restriction, Classical Training Alone
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionOther
Blood flow restriction with low load (30-50% 1RM) for 2 sessions in a week for 6 weeks during classical training will be applied.
Classical Training AloneOther
Classical training same as Group 1with moderate to high load (70-90% 1RM) for 2 sessions in a week for 6 weeks will be applied without blood restriction.
| Study group | Role | What they receive |
|---|---|---|
| Blood Flow Restriction + Classical Training | Experimental | Not described Receives: Other: Blood Flow Restriction |
| Classical Training Alone | Experimental | Not described Receives: Other: Classical Training Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Muscle Strength and Endurance
Isokinetic dynamometer
Measured: 6 weeks
Secondary outcomes (8)
Evaluation of Lower Extremity Power
Vertical jump test
Measured: 6 weeks
Evaluation of Aerobic Endurance
Yo-Yo Intermittent Recovery Level 1 test
Measured: 6 weeks
Evaluation of Change of Direction Speed
T Test
Measured: 6 weeks
Evaluation of Reactive Agility
Y-Shaped Reactive Agility Test
Measured: 6 weeks
Evaluation of Dynamic Balance
Y Balance Test
Measured: 6 weeks
Systemic Fatigue
Lactate analysis
Measured: 6 weeks
General Perceived Fatigue
Borg scale
Measured: 6 weeks
Evaluation of General Satisfaction and Perceived Performance Change
General satisfaction and the change in performance perceived by the participants will be evaluated with the 7 points Global Rating of Change Scale after the training program. According to the scale, it is expressed as "-3: I am much worse, -2: I am worse, -1: I am a little worse, 0: No change, 1: I am a little better, 2: I am better, 3: I am much better".
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start12 Dec 2022
- Primary completion27 Apr 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular OcclusionStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Begum Kara Kaya, Biruni University
- Investigators
- Ayse Zengin Alpözgen, PhD, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452109
- Sponsor's protocol ID
- DrTez
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2022
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kara Kaya B, Alpozgen AZ, Alpozgen MR, Dikmen G. Performance and injury-related effects of low-load blood flow restriction training in amateur soccer players: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Dec 20;18(1):32. doi: 10.1186/s13102-025-01416-8.
PubMed 41422254
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Football-Related Performance Parameters: Application of Blood Flow Restrictive Exercise
- ClinicalTrials.gov ID
- NCT05452109
- Acronym / sponsor ID
- DrTez
- Conditions
- Vascular Occlusion, Soccer, Exercise, EMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 11 Jul 2022 (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 blood flow restriction method can have similar or superior effects to high-intensity exercises even in a short duration, which can positively affect some performance parameters, can be applied with low-intensity load and cause hypertrophy in the muscle by providing high metabolic stress, facilitating muscle growth without significantly changing the total training dose. The aim of this study is to investigate whether adding the blood flow restriction method to the classical training program can be more effective than the classical training applied alone in the development of football-related performance parameters.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Flow Restriction + Classical Training | Experimental | Other: Blood Flow Restriction |
| Classical Training Alone | Experimental | Other: Classical Training Alone |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being a male between the ages of 18-30 years
- Volunteer to participate in the study
- Playing football in one of the clubs in Istanbul for at least 1 year
- Being in the pre-season of the club
- Absence of any ongoing musculoskeletal problems that limit exercising
Key exclusion criteria (4 listed)
- Having at least one of the contraindications preventing the application of blood flow restriction (Smoking, previous venous thromboembolism, risk of peripheral vascular disease (ankle-brachial index <0.9), coronary heart disease, hypertension, hemophilia, etc.).
- History of sports injury in the last 6 months
- Orthopedic lower extremity surgery in the last 1 year
- Body mass index ≥ 30 kg/m2
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 RestrictionBlood flow restriction with low load (30-50% 1RM) for 2 sessions in a week for 6 weeks during classical training will be applied. | Other | Blood Flow Restriction + Classical Training |
| Classical Training AloneClassical training same as Group 1with moderate to high load (70-90% 1RM) for 2 sessions in a week for 6 weeks will be applied without blood restriction. | Other | Classical Training Alone |
Primary outcome
Evaluation of Muscle Strength and Endurance
Time frame: 6 weeks
Isokinetic dynamometer
8 secondary outcomes
Evaluation of Lower Extremity Power
Time frame: 6 weeks
Evaluation of Aerobic Endurance
Time frame: 6 weeks
Evaluation of Change of Direction Speed
Time frame: 6 weeks
Evaluation of Reactive Agility
Time frame: 6 weeks
Evaluation of Dynamic Balance
Time frame: 6 weeks
Systemic Fatigue
Time frame: 6 weeks
General Perceived Fatigue
Time frame: 6 weeks
Evaluation of General Satisfaction and Perceived Performance Change
Time frame: 6th week
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 23 Jan 2024.
- Derived from this study: PubMed 41422254Kara Kaya B, Alpozgen AZ, Alpozgen MR, Dikmen G. Performance and injury-related effects of low-load blood flow restriction training in amateur soccer players: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Dec 20;18(1):32. doi: 10.1186/s13102-025-01416-8.
- 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.
Ayse Zengin Alpözgen, PhD study chair
Istanbul University - Cerrahpasa
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 and Classical Training Alone in people with Vascular Occlusion and Soccer, run by Biruni University at 2 sites in Turkey (Türkiye).
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 5 inclusion and 4 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 23 Jan 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 Turkey (Türkiye). 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?
Evaluation of Muscle Strength and Endurance (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452109, which also lists 1 linked publication.
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 23 Jan 2024.