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

NCT06512961 | Enrolling By Invitation

• 1 other identifier: 78229724.9.0000.5402
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. Tissue Flossing (TF) appears as an affordable alternative, but lacks solid scientific evidence.

Conditions

Muscle Strength; Hypertrophy

Keywords

Tissue flossing; Blood flow restriction

Outcome Measures

Primary Outcomes (15)

• 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.

  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).

  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.

  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.

  3 days

• Weight

  It will be collected with a weight balance

  3 days

• Height

  It will be collected with a stadiometer

  1 day

• Body Fat

  It will be collected with a adipometer

  1 day

• Arterial pressure

  It will be collected with a sphygmomanometer

  1 day

• Perimetry of the dominant upper limb

  It will be defined by the Waterloo Footedness

  1 day

• Limb length

  Identified with a measuring tape

  1 day

• Perceived exertion scale

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

  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.

  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.

  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).

  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.

  up to 15 weeks

Study Arms (2)

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.

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.

Device: Tissue Flossing; Other: Training Protocol

Interventions

Blood Flow Restriction Cuff DEVICE

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

Group Traditional BFR

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.

Group BFR TF; Group Traditional BFR

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.

Group BFR TF

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who present one or more of the following characteristics will not be included:
• presence of any health condition that contraindicates or prevents exercise;
• diabetes and diagnosed high blood pressure;
• inflammatory, psychiatric, cardiovascular and/or respiratory rheumatological disease; - -4 being dependent on alcohol, consuming drugs and/or being a smoker;
• 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);
• use of ergogenic supplements to improve physical performance and/or muscle mass and/or vasoactive medications;
• having one or more risk factors predisposing to thromboembolism

You may not qualify if:

• Participants will be excluded from the study if they:
• have a health problem that does not allow them to continue;
• wish to leave the study;
• not sign the consent form

Sponsors & Collaborators

• Paulista University: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator

Study Sites (1)

UNESP

Presidente Prudente, São Paulo, 19060900, Brazil

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 22, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)