Reliability and Performance Analysis of the Use of Tissue Flossing for Blood Flow Restriction.

NCT06075901 | Enrolling By Invitation

• 1 other identifier: FCT - UNESP
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Blood flow restriction (RFS) 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

Hypertrophy; Muscle Strength

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 posterior tibial 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 tibial artery is interrupted.

  First and Secund Stage - [Time Frame: baseline]

• 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 tibial artery, enabling variables to be assessed. Doppler flow measurements of MI (peak systolic velocity \[cm/s\], end-diastolic velocity \[cm/s\] and arterial diameter).

  First Stage - [Time Frame: baseline and all subsequent assessments]

• 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.

  First and Secund Stage - [Time Frame: baseline and all subsequent assessments]

• 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.

  First Stage - [Time Frame: The subsequent assessments]

• Weight

  It will be collected with a weight balance

  First and Secund Stage- [Time Frame: Baseline ]

• Height

  It will be collected with a stadiometer

  First and Secund Stage- [Time Frame: Baseline ]

• Body Fat

  It will be collected with a adipometer

  First and Secund Stage- [Time Frame: Baseline ]

• Arterial pressure

  It will be collected with a sphygmomanometer

  First and Secund Stage- [Time Frame: Baseline ]

• Perimetry of the dominant lower limb

  It will be defined by the Waterloo Footedness

  First and Secund Stage- [Time Frame: Baseline ]

• Limb length

  Identified with a measuring tape

  First and Secund Stage- [Time Frame: Baseline ]

• Perceived exertion scale

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

  Secund Stage- [Time Frame: at the end of the training sessions]

• Method preference

  Participants must answer a brief questionnaire about their preference for one of the RFS methods carried out, and justify why they chose it.

  Secund Stage- [Time Frame: final evaluation]

• 1 Maximum Repetition Test

  The participant must be positioned seated on the extension chair with knees and feet hip-width apart, knees at 90° flexion determined by goniometry, hands holding the handles adjacent to the hips and lumbosacral spine in a firm position in contact with the back of the chair. 1 repetition should be performed to familiarize the movement and 10 repetitions to warm up. At the beginning of the test, they will be instructed to maintain a movement pattern and avoid compensation. The RM is then defined by the highest load at which the participant is capable of performing 1 repetition without compensation.

  Secund Stage- [Time Frame: baseline and final evaluation]

• 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).

  Secund Stage- [Time Frame: baseline during follow-up and final evaluation]

• Ultrasound

  The assessment of the muscular structure will be carried out using ultrasound images of the participant's lower limbs, which will be captured using BodyMetrix BX-2000. Participants will be assessed in the supine position with legs 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.

  Secund Stage- [Time Frame: baseline and final evaluation]

Study Arms (2)

Blood Flow Restriction with Cuffing

ACTIVE COMPARATOR

The participant will use the Cuffing for Blood Flow Restriction training

Device: Blood Flow Restriction Cuff; Other: Training Protocol

Blood Flow Restriction with Tissue Flossing

EXPERIMENTAL

The participant will use Tissue Flossing for Blood Flow Restriction training

Device: Tissue Flossing; Other: Training Protocol

Interventions

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 with Tissue Flossing

Blood Flow Restriction Cuff DEVICE

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

Blood Flow Restriction with Cuffing

Training Protocol OTHER

The lower limb resistance training protocol will follow that recommended in the study by Patterson et al. for resistance training, and will last 4 weeks, with 3 training sessions per week, with a day break between sessions.

Blood Flow Restriction with Cuffing; Blood Flow Restriction with Tissue Flossing

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• 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 lower 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

Study Sites (1)

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 55, 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: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)