Clinical trial NCT06512961: Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Reliability and Performance Analysis
Official title: Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb: Study of Reliability, Reproducibility and Performance Analysis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertrophy
Muscle Strength
Keywords: Tissue flossing
Blood flow restriction
Lead sponsor: Paulista University
Sponsor class: OTHER
Collaborators: name: Coordination for the Improvement of Higher Education Personnel
First posted: 2024-07-22
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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 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

Primary outcomes:
measure: Occlusion pressures (AOP, 80% and 40% of AOP)
timeFrame: 3 days
measure: Assessment of arterial flow and diameter
timeFrame: 3 days
measure: Perceptual parameter
timeFrame: 3 days
measure: Tissue Flossing Assessment
timeFrame: 3 days
measure: Weight
timeFrame: 3 days
measure: Height
timeFrame: 1 day
measure: Body Fat
timeFrame: 1 day
measure: Arterial pressure
timeFrame: 1 day
measure: Perimetry of the dominant upper limb
timeFrame: 1 day
measure: Limb length
timeFrame: 1 day
measure: Perceived exertion scale
timeFrame: up to 15 weeks
measure: Method preference
timeFrame: up to 15 weeks
measure: 1 Maximum Repetition Test
timeFrame: up to 15 weeks
measure: Myotonometry
timeFrame: up to 15 weeks
measure: Ultrasound
timeFrame: up to 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: UNESP
state: São Paulo
Study officials:
References: