Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06512961

Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Reliability 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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Hypertrophy Muscle Strength Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UNESP

Presidente Prudente, São Paulo, 19060900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Tissue Flossing

Device

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 Cuff

Device

Inflatable device that exerts an external pressure above a muscle or joint of the extremities.

Training Protocol

Other

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. Weight

    Time frame: 3 days

    It will be collected with a weight balance

  6. Height

    Time frame: 1 day

    It will be collected with a stadiometer

  7. Body Fat

    Time frame: 1 day

    It will be collected with a adipometer

  8. Arterial pressure

    Time frame: 1 day

    It will be collected with a sphygmomanometer

  9. Perimetry of the dominant upper limb

    Time frame: 1 day

    It will be defined by the Waterloo Footedness

  10. Limb length

    Time frame: 1 day

    Identified with a measuring tape

  11. Perceived exertion scale

    Time frame: up to 15 weeks

    Adapted BORG scale, with 0 being "no effort" and 10 "maximum effort".

  12. 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.

  13. 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.

  14. 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).

  15. 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.

Sponsors and collaborators

Lead sponsor

Paulista University

Other

Collaborators

  • Coordination for the Improvement of Higher Education Personnel

Registry information

Official study title

Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Study of Reliability, Reproducibility and Performance Analysis

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.