Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512961
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-25
Brief Title:
Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb Reliability and Performance Analysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Applicability of Tissue Flossing for Blood Flow Restriction in the Upper Limb Study of Reliability Reproducibility and Performance Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 p005 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 FCTUNESP Presidente Prudente SP Brazil
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 p005 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 FCTUNESP Presidente Prudente SP Brazil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None