HypertrophyNCT06512961
Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Reliability and Performance Analysis
A study testing Tissue Flossing, Blood Flow Restriction Cuff and Training Protocol in people with Hypertrophy and Muscle Strength, run by Paulista University at 1 site in Brazil.
Trial summary
Blood flow restriction (BFR) is a widely studied technique that combines low-intensity exercise with vascular occlusion, resulting in muscular benefits. However, its application is challenging due to methodological variations and equipment costs. 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
- Hypertrophy, Muscle Strength
- What is being tested?
- Tissue Flossing, Blood Flow Restriction Cuff and Training Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2025to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Individuals who present one or more of the following characteristics will not be included:
- 1 presence of any health condition that contraindicates or prevents exercise;
- 2 diabetes and diagnosed high blood pressure;
- 3 inflammatory, psychiatric, cardiovascular and/or respiratory rheumatological disease; - -4 being dependent on alcohol, consuming drugs and/or being a smoker;
- 5 history of knee surgery (e.g., meniscal repair and ligament reconstruction) or recent upper limb musculoskeletal injury that may impair performance during tests or interventions (e.g., muscle injury, tendinopathy, patellofemoral pain and/or back pain column in the last six months);
- 6 use of ergogenic supplements to improve physical performance and/or muscle mass and/or vasoactive medications;
- 7 having one or more risk factors predisposing to thromboembolism
Who cannot join
- Participants will be excluded from the study if they:
- 1 have a health problem that does not allow them to continue;
- 2 wish to leave the study;
- 3 not sign the consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Study of Reliability, Reproducibility and Performance Analysis
Blood flow restriction (BFR) is a widely studied technique that combines low-intensity exercise with vascular occlusion, resulting in muscular benefits. However, its application is challenging due to methodological variations and equipment costs. Tissue Flossing (TF) appears as an affordable alternative, but lacks solid scientific evidence.
Read the detailed description
Objectives: to evaluate the intra- and inter-rater reliability of the occlusion pressure generated by TF, investigate the reproducibility of TF application on different days and compare TF with traditional RFS in terms of muscle gains.
Methods: the study is divided into two stages: First stage, randomized controlled crossover clinical trial, 80 healthy individuals aged 18 to 30 years old evaluated to determine the reliability of the TF. Participants will follow one of two types of randomization, with exclusions based on health criteria. Assessments include anthropometric characteristics, determination of occlusion pressure (POT), identification of 40% and 80% of POT, flow data and arterial diameter after TF application. Statistical analysis will use the intraclass correlation index (ICC) and specific models for intra- and inter-rater analyses. Second stage, randomized controlled clinical trial with parallel groups, 34 participants will be evaluated over fifteen weeks. The initial procedures involve anthropometric assessments, POT determination, myotonometry, ultrasound, perceptual scale and 1RM test, applied to both upper limbs. Participants will perform a upper limb training protocol using RFS or TF, following myotonometric and perceptual assessments. After training, final assessments will measure the same parameters initially assessed. Statistical analysis will use normality tests, Generalized Mixed Models and effect size analysis in SPSS software, with a significance level of p<0.05. Expected results: This study is expected to provide information on the reliability and reproducibility of TF in generating occlusion pressure. Furthermore, the investigatorsF seek to validate TF by comparing it with traditional RFS in terms of muscle gains. If effective, TF could become an affordable option to promote muscle gains, in different application scenarios.
Participants will be duly informed about the procedures and objectives of this study, and after agreeing, they will sign an informed consent form, effectively becoming part of it. In the consent form, participants will be asked if they agree to the use of their data if they choose to withdraw from the study. Participants will also be asked for permission for the research team to share relevant data with people at universities participating in the research or regulatory authorities, where relevant. The study were approved to the Research Ethics Committee of FCT/UNESP, Presidente Prudente, SP, Brazil.
- Conditions
- Hypertrophy, Muscle Strength
- Being tested
- Tissue Flossing, Blood Flow Restriction Cuff, Training Protocol
- Keywords
- Tissue flossing, Blood flow restriction
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue FlossingDevice
Tissue Flossing ia a elastic band that when applied exerts an external pressure above or below a muscle or joint of the extremities.
Blood Flow Restriction CuffDevice
Inflatable device that exerts an external pressure above a muscle or joint of the extremities.
Training ProtocolOther
The upper limb resistance training protocol will follow that recommended in the study by Patterson et al. for resistance training, and will last 15weeks, with 3 training sessions per week, with a day break between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group Traditional BFR | Active comparator | This group will perform the training protocol with traditional BFR, using a pressure cuff as an occluder on both arms. Receives: Device: Blood Flow Restriction Cuff; Other: Training Protocol |
| Group BFR TF | Experimental | This group will perform the training protocol with BFR using TF on both arms. Receives: Device: Tissue Flossing; Other: Training Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion pressures (AOP, 80% and 40% of AOP)
To determine the AOP, the Doppler equipment transducer will be used, which will be positioned over the brachii artery to capture the auscultatory pulse. A blood pressure cuff will be fixed to the participant's thigh close to the region of the inguinal fold of the dominant limb, and then with the inflatable region of the cuff on the medial portion of the thigh covering the femoral artery, it will be progressively inflated, waiting 15 seconds every 30 mmHg until the point at which the auscultatory pulse of the brachii artery is interrupted.
Measured: 3 days
Assessment of arterial flow and diameter
A Sonoline Sienna® vascular ultrasound will be used combined with a 40mm B-mode ultrasonic transducer with a 7.5 MHz linear beam, which will be coated with gel for acoustic contact and positioned longitudinally to the posterior brachii artery, enabling variables to be assessed. Doppler flow measurements of upper limb (peak systolic velocity [cm/s], end-diastolic velocity [cm/s] and arterial diameter).
Measured: 3 days
Perceptual parameter
The perceptual parameter will be evaluated using a Borg CR10+ scale, representing the perception of discomfort, 0 represents no discomfort and 10 extremely uncomfortable.
Measured: 3 days
Tissue Flossing Assessment
The application of tissue flossing on the leg will be carried out by always passing the elastic tape with 50% of the tape over the next strip, until the end of the elastic tape.
Measured: 3 days
Weight
It will be collected with a weight balance
Measured: 3 days
Height
It will be collected with a stadiometer
Measured: 1 day
Body Fat
It will be collected with a adipometer
Measured: 1 day
Arterial pressure
It will be collected with a sphygmomanometer
Measured: 1 day
Perimetry of the dominant upper limb
It will be defined by the Waterloo Footedness
Measured: 1 day
Limb length
Identified with a measuring tape
Measured: 1 day
Perceived exertion scale
Adapted BORG scale, with 0 being "no effort" and 10 "maximum effort".
Measured: up to 15 weeks
Method preference
Participants must answer a brief questionnaire about their preference for one of the BFR methods carried out, and justify why they chose it.
Measured: up to 15 weeks
1 Maximum Repetition Test
The warm-up will include a series of 6 to 10 repetitions, using approximately 50% of the estimated load for the first attempt of the test (44). This warm-up will not only prepare participants but also familiarize them with the movement. The determination of the initial warm-up load will be made subjectively by the researcher responsible for the study, considering the participant's height, body mass and training experience as reference points (45).
After the warm-up phase, up to five attempts will be given to find the 1RM, with intervals of 3 to 5 minutes between them (46). The load adjustment for subsequent attempts will be determined by the subjective perception of effort, according to the BORG scale, where the greater the perception of effort, the lower the percentage of load added for the next attempt. The 1RM will be established as the maximum load at which the participant can perform one repetition without compensation.
Measured: up to 15 weeks
Myotonometry
Myotonometry will be assessed using the MyotonPRO® tool, which consists of a portable, wireless and non-invasive device.
The measurement will be carried out once, and in each shot, the following myotonometry parameters will be calculated: the state of tension (tone) and biomechanical properties (rigidity and elasticity).
Measured: up to 15 weeks
Ultrasound
The assessment of the muscular structure will be carried out using ultrasound images of the participant's upper limbs, which will be captured using BodyMetrix BX-2000.
Participants will be assessed in the supine position with arms fully extended and muscles relaxed. The ultrasound transducer will be covered with water-soluble transmission gel and positioned perpendicular to the skin over the muscle.
Measured: up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Aug 2025
- Primary completion15 Jun 2026
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrophyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paulista University
- Sponsor type
- University, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Responsible party
- Principal investigator, Franciele Marques Vanderle, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512961
- Sponsor's protocol ID
- 78229724.9.0000.5402
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Study of Reliability, Reproducibility and Performance Analysis
- ClinicalTrials.gov ID
- NCT06512961
- Acronym / sponsor ID
- 78229724.9.0000.5402
- Conditions
- Hypertrophy, Muscle Strength
- Keywords
- Tissue flossing, Blood flow restriction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 22 Jul 2024 (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.
Blood flow restriction (BFR) is a widely studied technique that combines low-intensity exercise with vascular occlusion, resulting in muscular benefits. However, its application is challenging due to methodological variations and equipment costs. Tissue Flossing (TF) appears as an affordable alternative, but lacks solid scientific evidence.
Detailed description
Objectives: to evaluate the intra- and inter-rater reliability of the occlusion pressure generated by TF, investigate the reproducibility of TF application on different days and compare TF with traditional RFS in terms of muscle gains.
Methods: the study is divided into two stages: First stage, randomized controlled crossover clinical trial, 80 healthy individuals aged 18 to 30 years old evaluated to determine the reliability of the TF. Participants will follow one of two types of randomization, with exclusions based on health criteria. Assessments include anthropometric characteristics, determination of occlusion pressure (POT), identification of 40% and 80% of POT, flow data and arterial diameter after TF application. Statistical analysis will use the intraclass correlation index (ICC) and specific models for intra- and inter-rater analyses. Second stage, randomized controlled clinical trial with parallel groups, 34 participants will be evaluated over fifteen weeks. The initial procedures involve anthropometric assessments, POT determination, myotonometry, ultrasound, perceptual scale and 1RM test, applied to both upper limbs. Participants will perform a upper limb training protocol using RFS or TF, following myotonometric and perceptual assessments. After training, final assessments will measure the same parameters initially assessed. Statistical analysis will use normality tests, Generalized Mixed Models and effect size analysis in SPSS software, with a significance level of p<0.05. Expected results: This study is expected to provide information on the reliability and reproducibility of TF in generating occlusion pressure. Furthermore, the investigatorsF seek to validate TF by comparing it with traditional RFS in terms of muscle gains. If effective, TF could become an affordable option to promote muscle gains, in different application scenarios.
Participants will be duly informed about the procedures and objectives of this study, and after agreeing, they will sign an informed consent form, effectively becoming part of it. In the consent form, participants will be asked if they agree to the use of their data if they choose to withdraw from the study. Participants will also be asked for permission for the research team to share relevant data with people at universities participating in the research or regulatory authorities, where relevant. The study were approved to the Research Ethics Committee of FCT/UNESP, Presidente Prudente, SP, Brazil.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Traditional BFR | Active comparator | Device: Blood Flow Restriction Cuff, Other: Training ProtocolThis group will perform the training protocol with traditional BFR, using a pressure cuff as an occluder on both arms. |
| Group BFR TF | Experimental | Device: Tissue Flossing, Other: Training ProtocolThis group will perform the training protocol with BFR using TF on both arms. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals who present one or more of the following characteristics will not be included:
- 1 presence of any health condition that contraindicates or prevents exercise;
- 2 diabetes and diagnosed high blood pressure;
- 3 inflammatory, psychiatric, cardiovascular and/or respiratory rheumatological disease; - -4 being dependent on alcohol, consuming drugs and/or being a smoker;
- 5 history of knee surgery (e.g., meniscal repair and ligament reconstruction) or recent upper limb musculoskeletal injury that may impair performance during tests or interventions (e.g., muscle injury, tendinopathy, patellofemoral pain and/or back pain column in the last six months);
Key exclusion criteria (4 listed)
- Participants will be excluded from the study if they:
- 1 have a health problem that does not allow them to continue;
- 2 wish to leave the study;
- 3 not sign the consent form
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 |
|---|---|---|
| Tissue FlossingTissue Flossing ia a elastic band that when applied exerts an external pressure above or below a muscle or joint of the extremities. | Device | Group BFR TF |
| Blood Flow Restriction CuffInflatable device that exerts an external pressure above a muscle or joint of the extremities. | Device | Group Traditional BFR |
| Training ProtocolThe upper limb resistance training protocol will follow that recommended in the study by Patterson et al. for resistance training, and will last 15weeks, with 3 training sessions per week, with a day break between sessions. | Other | Group BFR TF, Group Traditional BFR |
Primary outcome
Occlusion pressures (AOP, 80% and 40% of AOP)
Time frame: 3 days
To determine the AOP, the Doppler equipment transducer will be used, which will be positioned over the brachii artery to capture the auscultatory pulse. A blood pressure cuff will be fixed to the participant's thigh close to the region of the inguinal fold of the dominant limb, and then with the inflatable region of the cuff on the medial portion of the thigh covering the femoral artery, it will be progressively inflated, waiting 15 seconds every 30 mmHg until the point at which the auscultatory pulse of the brachii artery is interrupted.
Assessment of arterial flow and diameter
Time frame: 3 days
A Sonoline Sienna® vascular ultrasound will be used combined with a 40mm B-mode ultrasonic transducer with a 7.5 MHz linear beam, which will be coated with gel for acoustic contact and positioned longitudinally to the posterior brachii artery, enabling variables to be assessed. Doppler flow measurements of upper limb (peak systolic velocity [cm/s], end-diastolic velocity [cm/s] and arterial diameter).
Perceptual parameter
Time frame: 3 days
The perceptual parameter will be evaluated using a Borg CR10+ scale, representing the perception of discomfort, 0 represents no discomfort and 10 extremely uncomfortable.
Tissue Flossing Assessment
Time frame: 3 days
The application of tissue flossing on the leg will be carried out by always passing the elastic tape with 50% of the tape over the next strip, until the end of the elastic tape.
Weight
Time frame: 3 days
It will be collected with a weight balance
Height
Time frame: 1 day
It will be collected with a stadiometer
Body Fat
Time frame: 1 day
It will be collected with a adipometer
Arterial pressure
Time frame: 1 day
It will be collected with a sphygmomanometer
Perimetry of the dominant upper limb
Time frame: 1 day
It will be defined by the Waterloo Footedness
Limb length
Time frame: 1 day
Identified with a measuring tape
Perceived exertion scale
Time frame: up to 15 weeks
Adapted BORG scale, with 0 being "no effort" and 10 "maximum effort".
Method preference
Time frame: up to 15 weeks
Participants must answer a brief questionnaire about their preference for one of the BFR methods carried out, and justify why they chose it.
1 Maximum Repetition Test
Time frame: up to 15 weeks
The warm-up will include a series of 6 to 10 repetitions, using approximately 50% of the estimated load for the first attempt of the test (44). This warm-up will not only prepare participants but also familiarize them with the movement. The determination of the initial warm-up load will be made subjectively by the researcher responsible for the study, considering the participant's height, body mass and training experience as reference points (45). After the warm-up phase, up to five attempts will be given to find the 1RM, with intervals of 3 to 5 minutes between them (46). The load adjustment for subsequent attempts will be determined by the subjective perception of effort, according to the BORG scale, where the greater the perception of effort, the lower the percentage of load added for the next attempt. The 1RM will be established as the maximum load at which the participant can perform one repetition without compensation.
Myotonometry
Time frame: up to 15 weeks
Myotonometry will be assessed using the MyotonPRO® tool, which consists of a portable, wireless and non-invasive device. The measurement will be carried out once, and in each shot, the following myotonometry parameters will be calculated: the state of tension (tone) and biomechanical properties (rigidity and elasticity).
Ultrasound
Time frame: up to 15 weeks
The assessment of the muscular structure will be carried out using ultrasound images of the participant's upper limbs, which will be captured using BodyMetrix BX-2000. Participants will be assessed in the supine position with arms fully extended and muscles relaxed. The ultrasound transducer will be covered with water-soluble transmission gel and positioned perpendicular to the skin over the muscle.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Flossing, Blood Flow Restriction Cuff and Training Protocol in people with Hypertrophy and Muscle Strength, run by Paulista University at 1 site in Brazil.
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 7 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: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
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?
Occlusion pressures (AOP, 80% and 40% of AOP) (time frame: 3 days). The study lists 15 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 18 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.