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

Official title

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

Overview

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.

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, 110 recreational athletes will be evaluated over four weeks. The initial procedures involve anthropometric assessments, POT determination, myotonometry, ultrasound, perceptual scale and 1RM test, applied to both lower limbs. Participants will perform a lower limb training protocol, using RFS and TF on different legs, 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, we 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 will be sent for consideration and approval to the Research Ethics Committee of FCT/UNESP, Presidente Prudente, SP, Brazil.

Interventions

• Device Tissue Flossing
  Tissue Flossing ia a elastic band that when applied exerts an external pressure above or below a muscle or joint of the extremities.
• Device Blood Flow Restriction Cuff
  Inflatable device that exerts an external pressure above a muscle or joint of the extremities.
• Other Training Protocol
  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.

Primary outcome measures

• Occlusion pressures (AOP, 80% and 40% of AOP) [Time frame: First and Secund Stage - [Time Frame: baseline]]
• Assessment of arterial flow and diameter [Time frame: First Stage - [Time Frame: baseline and all subsequent assessments]]
• Perceptual parameter [Time frame: First and Secund Stage - [Time Frame: baseline and all subsequent assessments]]
• Tissue Flossing Assessment [Time frame: First Stage - [Time Frame: The subsequent assessments]]
• Weight [Time frame: First and Secund Stage- [Time Frame: Baseline ]]
• Height [Time frame: First and Secund Stage- [Time Frame: Baseline ]]
• Body Fat [Time frame: First and Secund Stage- [Time Frame: Baseline ]]
• Arterial pressure [Time frame: First and Secund Stage- [Time Frame: Baseline ]]
• Perimetry of the dominant lower limb [Time frame: First and Secund Stage- [Time Frame: Baseline ]]
• Limb length [Time frame: First and Secund Stage- [Time Frame: Baseline ]]

Eligibility criteria

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 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);
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Brazil · 1 center

• Franciele Marques Vanderlei — Presidente Prudente

Identifiers

NCT: NCT06075901 · FCT - UNESP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗