High-Intensity Interval TrainingNCT05274542
Acute Effect of Blood Flow Restricted High-Intensity Resistive Training
A study testing high intensity with blood flow restriction and high intensity without blood flow restriction group in people with High-Intensity Interval Training and Blood Flow Restriction Exercise, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Recommended by many professional organizations such as the American College of Sports Medicine (ACSM) and the National Strength and Conditioning Association (NSCA), resistance exercise training improves muscle strength, body composition, performance, functionality and quality of life in healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- High-Intensity Interval Training, Blood Flow Restriction Exercise
- What is being tested?
- high intensity with blood flow restriction and high intensity without blood flow restriction group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2022to 7 Dec 2022
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-25
- Healthy
- Be volunteer to participate the study
Who cannot join
- Pregnancy
- Breastfeeding status
- Cardiovascular disease
- Musculoskeletal problems
- Orthopedic problems related to the lower extremities
- Peripheral or central neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effect of Blood Flow Restricted High-Intensity Resistive Training on Rectus Femoris Muscle Activity, Reaction Time, Muscular Performance, and Fatigue Level
Recommended by many professional organizations such as the American College of Sports Medicine (ACSM) and the National Strength and Conditioning Association (NSCA), resistance exercise training improves muscle strength, body composition, performance, functionality and quality of life in healthy young adults. Blood flow restriction (BFR), also known as Kaatsu training, is proposed as a new method to improve muscle strength and muscle hypertrophy in a short time. Although there are studies in the literature in which BFR is applied with low-intensity resistance training, no studies have been found examining the effects of BFR applied with high-intensity resistance training on the neuromuscular adaptations of the quadriceps femoris muscle. Determining whether high-intensity resistance training with BFR is more effective on the quadriceps femoris muscle compared to high-intensity resistance training applied without BFR may provide faster and more effective responses by arranging resistance training protocols in terms of neuromuscular gains. Between 07.03.2022 and 07.06.2022, in the Biruni University Physiotherapy and Rehabilitation Department Application Laboratory, in which 24 healthy young adults between the ages of 18-25 (from 12 BFR, 12 BFR) will be included, exercise training to be applied with and without BFR was determined. Its effects will be compared with electromyographic measurement, single leg squat test, and measurement of late-onset muscle pain (Visual Analog Scale). IBM SPSS 21.0 statistical program will be used for statistical analysis. Whether the variables are suitable for normal distribution will be analyzed with the Shapiro-Wilk test. If the variables show normal distribution, the variation within the group will be analyzed with the paired samples t test, and if it does not show normal distribution, the Wilcoxon Signed rank test will be analyzed. Comparison of groups will be made with independent samples t-test in independent groups if the variables show normal distribution, and with Mann Whitney-U test if they do not show normal distribution. Categorical data distributions will be evaluated with the Chi-square test.
- Being tested
- high intensity with blood flow restriction, high intensity without blood flow restriction group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity with blood flow restrictionOther
Participants in high intensity with blood flow restriction group (n=12) will be given high-intensity resistance exercise training that restricts blood flow. Open kinetic chain rectus femoris resistance exercise training will be given with free weights, 80% of 1 RM with 8 repetitions, 2 sets and 3 minutes rest between sets. The exercises will be performed in a single session accompanied by a physiotherapist. A blood pressure cuff will be used to restrict blood flow. By applying the cuff to the proximal of the muscle, the blood flow will be restricted with a pressure of 150 mmHg and the muscle will be exercised in this way. After the exercise, the cuff will be removed and evaluations will be made after 2 minutes of rest.
high intensity without blood flow restriction groupOther
Participants in high intensity without blood flow restriction group (n=12) will be given high-intensity resistance exercise training. Open kinetic chain rectus femoris resistance exercise training will be given with free weights, 80% of 1 RM with 8 repetitions, 2 sets and 3 minutes rest between sets. The exercises will be performed in a single session accompanied by a physiotherapist. After the exercise, after 2 minutes of rest, evaluations will be made.
| Study group | Role | What they receive |
|---|---|---|
| high intensity with blood flow restriction group | Experimental | Not described Receives: Other: high intensity with blood flow restriction |
| high intensity without blood flow restriction group | Active comparator | Not described Receives: Other: high intensity without blood flow restriction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG measurement
Electrodes in the RF muscle are placed in the middle of the muscle abdominals according to the recommendations of the Surface Electromyography for Non-Invasive Evaluation of Muscles club and the International Society of Electrophysiology and Kinesiology. Data will be evaluated with the Neurotrac® Simplex (Verity Medical Ltd., Braishfield, UK) wireless EMG device. The recording range in the device is between 0.2 µV - 2000 µV and has a 0.1 µV RMS sensitivity, 10 m free wireless (Bluetooth) connection range. The signals coming from the electrodes will be automatically filtered and transferred to digital media via software.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start7 Mar 2022
- Primary completion7 Jul 2022
- Study completion7 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for High-Intensity Interval TrainingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsena Utku, Halic University
- Investigators
- Gülsena Utku Umut, Principal investigator, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274542
- Sponsor's protocol ID
- HI-BFR training
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
PubMed 11018445Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
PubMed 21922259Korkmaz Dayican D, Ulker Eksi B, Yigit S, Utku Umut G, Ozyurek B, Yilmaz HE, Akinci B. Immediate Effects of High-Intensity Blood Flow Restriction Training on Muscle Performance and Muscle Soreness. Res Q Exerc Sport. 2025 Mar;96(1):213-222. doi: 10.1080/02701367.2024.2389902. Epub 2024 Aug 26.
PubMed 39186458
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Blood Flow Restricted High-Intensity Resistive Training on Rectus Femoris Muscle Activity, Reaction Time, Muscular Performance, and Fatigue Level
- ClinicalTrials.gov ID
- NCT05274542
- Acronym / sponsor ID
- HI-BFR training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 10 Mar 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.
Recommended by many professional organizations such as the American College of Sports Medicine (ACSM) and the National Strength and Conditioning Association (NSCA), resistance exercise training improves muscle strength, body composition, performance, functionality and quality of life in healthy young adults. Blood flow restriction (BFR), also known as Kaatsu training, is proposed as a new method to improve muscle strength and muscle hypertrophy in a short time. Although there are studies in the literature in which BFR is applied with low-intensity resistance training, no studies have been found examining the effects of BFR applied with high-intensity resistance training on the neuromuscular adaptations of the quadriceps femoris muscle. Determining whether high-intensity resistance training with BFR is more effective on the quadriceps femoris muscle compared to high-intensity resistance training applied without BFR may provide faster and more effective responses by arranging resistance training protocols in terms of neuromuscular gains. Between 07.03.2022 and 07.06.2022, in the Biruni University Physiotherapy and Rehabilitation Department Application Laboratory, in which 24 healthy young adults between the ages of 18-25 (from 12 BFR, 12 BFR) will be included, exercise training to be applied with and without BFR was determined. Its effects will be compared with electromyographic measurement, single leg squat test, and measurement of late-onset muscle pain (Visual Analog Scale). IBM SPSS 21.0 statistical program will be used for statistical analysis. Whether the variables are suitable for normal distribution will be analyzed with the Shapiro-Wilk test. If the variables show normal distribution, the variation within the group will be analyzed with the paired samples t test, and if it does not show normal distribution, the Wilcoxon Signed rank test will be analyzed. Comparison of groups will be made with independent samples t-test in independent groups if the variables show normal distribution, and with Mann Whitney-U test if they do not show normal distribution. Categorical data distributions will be evaluated with the Chi-square test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high intensity with blood flow restriction group | Experimental | Other: high intensity with blood flow restriction |
| high intensity without blood flow restriction group | Active comparator | Other: high intensity without blood flow restriction group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18-25
- Healthy
- Be volunteer to participate the study
Key exclusion criteria (6 listed)
- Pregnancy
- Breastfeeding status
- Cardiovascular disease
- Musculoskeletal problems
- Orthopedic problems related to the lower extremities
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 |
|---|---|---|
| high intensity with blood flow restrictionParticipants in high intensity with blood flow restriction group (n=12) will be given high-intensity resistance exercise training that restricts blood flow. Open kinetic chain rectus femoris resistance exercise training will be given with free weights, 80% of 1 RM with 8 repetitions, 2 sets and 3 minutes rest between sets. The exercises will be performed in a single session accompanied by a physiotherapist. A blood pressure cuff will be used to restrict blood flow. By applying the cuff to the proximal of the muscle, the blood flow will be restricted with a pressure of 150 mmHg and the muscle will be exercised in this way. After the exercise, the cuff will be removed and evaluations will be made after 2 minutes of rest. | Other | high intensity with blood flow restriction group |
| high intensity without blood flow restriction groupParticipants in high intensity without blood flow restriction group (n=12) will be given high-intensity resistance exercise training. Open kinetic chain rectus femoris resistance exercise training will be given with free weights, 80% of 1 RM with 8 repetitions, 2 sets and 3 minutes rest between sets. The exercises will be performed in a single session accompanied by a physiotherapist. After the exercise, after 2 minutes of rest, evaluations will be made. | Other | high intensity without blood flow restriction group |
Primary outcome
EMG measurement
Time frame: immediately after intervention
Electrodes in the RF muscle are placed in the middle of the muscle abdominals according to the recommendations of the Surface Electromyography for Non-Invasive Evaluation of Muscles club and the International Society of Electrophysiology and Kinesiology. Data will be evaluated with the Neurotrac® Simplex (Verity Medical Ltd., Braishfield, UK) wireless EMG device. The recording range in the device is between 0.2 µV - 2000 µV and has a 0.1 µV RMS sensitivity, 10 m free wireless (Bluetooth) connection range. The signals coming from the electrodes will be automatically filtered and transferred to digital media via software.
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 Feb 2023.
- Background: PubMed 11018445Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
- Background: PubMed 21922259Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
- Derived from this study: PubMed 39186458Korkmaz Dayican D, Ulker Eksi B, Yigit S, Utku Umut G, Ozyurek B, Yilmaz HE, Akinci B. Immediate Effects of High-Intensity Blood Flow Restriction Training on Muscle Performance and Muscle Soreness. Res Q Exerc Sport. 2025 Mar;96(1):213-222. doi: 10.1080/02701367.2024.2389902. Epub 2024 Aug 26.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Gülsena Utku Umut principal investigator
Halic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity with blood flow restriction and high intensity without blood flow restriction group in people with High-Intensity Interval Training and Blood Flow Restriction Exercise, run by Halic University at 1 site 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 3 inclusion and 6 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
EMG measurement (time frame: immediately after intervention). 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 NCT05274542, which also lists 3 linked publications.
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 Feb 2023.