Effects of Low Intensity, High Intensity Eccentric Resistance Training Associated With Blood Flow Restriction (oclusion)

March 8, 2021 updated by: Franciele Marques Vanderle, Paulista University

Effects of Low Intensity, High Intensity Eccentric Resistance Training Associated With Blood Flow Restriction: a Randomized Controlled Trial

Introduction: studies on resistance training of low intensity associated with blood flow restriction in recent years, although there are still gaps that can be explored in relation to their physiological phenomena when associated with eccentric training. In this way, from there the exploration becomes relevant the investigation of eccentric training associated to an RFS. Objective: To analyze and compare the effects of a high intensity and low intensity intensive resistance training associated with an RFS (TREAI-RFS and TREBI-RFS) with a high intensity eccentric resistance training without RFS (TREAI) in knee extensors. Method: The study will consist of 45 male participants, allocated from a stratified randomization into three groups: TREAI (n = 15), TREAI-RFS (n = 15) and TREBI-RFS (n = 15). Participants underwent a training program with a minimum of 40% without RFS, 80% with RFS and 40% with CVS of CVIM, 3 times a week, and the outcomes of muscle strength, muscle structure, power test and Endothelial growth will be assessed one week before, the fourth week and one week after the end of the training program. In addition, clinical markers of perception and recovery effort are investigated before and after a session. The graph used is descriptive and descriptive, as it is used as a model of analysis of variance for the analysis of replications without a two-factor scheme, which provides detailed information on how the measures are repeated, neither. A whole statistical analysis can reach the level of significance of 5%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Presidente Prudente, SP, Brazil, 55
        • Franciele Marques Vanderlei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male sex;
  • healthy;
  • aged between 18 and 35 years

Exclusion Criteria:

  • smokers;
  • alcoholics;
  • use drugs that influenced cardiac autonomic activity;
  • cardiovascular, metabolic or endocrine diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: HIET (n = 15)
High intensity eccentric training: A high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week.
Other: High intensity eccentric training
High intensity eccentric training group with 80% of isometric peak torque.
Experimental: HIET-BFR (n= 15)
High intensity eccentric training with blood flow restriction (BFR): A high intensity eccentric (80% isometric peak) training of the knee extensors in isokinetic will be performed, associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure) for 6 weeks, 3 times a week.
Other: High intensity eccentric training with BFR
Eccentric high intensity training group with 80% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).
Experimental: LIET-BFR (n = 15)
Low intensity eccentric training with blood flow restriction (BFR): A low intensity eccentric (40% isometric peak) training of the knee extensors in isokinetic will be performed associated with a pressure cuff placed in the proximal thigh (40% absolute occlusion pressure) for 6 weeks, 3 times a week.
Other: Low intensity eccentric training with BFR
Low intensity eccentric training group with 40% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).
Active Comparator: LIET (n= 15)
Low intensity eccentric training: A low intensity (40% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week.
Other: Low intensity eccentric training
Low intensity eccentric training group with 40% of isometric peak torque

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in muscle strength torque peaks at dinamometer isokinetic
Time Frame: baseline, fourth week and one week after sixth week
The isometric, eccentric and concentric torque peaks will be measured with an isokinetic dynamometer in order to evaluate the adaptations of knee extensor force to eccentric training.
baseline, fourth week and one week after sixth week
Change in muscular structure with ultrasonography
Time Frame: baseline, fourth week and one week after sixth week.
Ultrasonographic imaging of the dominant lower limb will be captured to determine muscle thickness of the vastus lateralis (VL) and rectus femoris (RF) muscles.
baseline, fourth week and one week after sixth week.
Change in Vascular Endothelial Growth Factor (VEGF)
Time Frame: baseline, fourth week and one week after sixth week.
For the analysis of the concentration of endothelial growth factor (VEGF) will be collected 10 ml of blood sample. The plasma of this sample will be stored at -80 ° C for further analysis.
baseline, fourth week and one week after sixth week.
Change in muscle power test
Time Frame: baseline, fourth week and one week after sixth week.
The strength and muscle power tests will be performed on a vertical squat with a guided bar.
baseline, fourth week and one week after sixth week.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain threshold
Time Frame: Assessed at baseline, 4th week, and 6th week.
To assess the pain threshold, the pressure algometer will be applied at five specific locations on the quadriceps.
Assessed at baseline, 4th week, and 6th week.
Analog Visual Scale
Time Frame: Assessed at baseline, 4th week, and 6th week.
The subjective evaluation of pain will be obtained through the Visual Analogue Scale (EVA), graded from 0 to 10, with zero being the total absence of pain and 10 the maximum level of pain supported by the participant.
Assessed at baseline, 4th week, and 6th week.
Perceived Effort Scale (Borg)
Time Frame: Assessed at baseline, 4th week, and 6th week.
The degree of subjective exertion reported by the participants in relation to the lower limbs will be analyzed by Borg's scale of perception of effort of 6 to 20 points, 6 being "very easy" and 20 being "exhaustive."
Assessed at baseline, 4th week, and 6th week.
Recovery Perception Scale
Time Frame: Assessed at baseline, 4th week, and 6th week.
The perception of recovery of the lower limb submitted to the eccentric exercise protocol will be evaluated by means of a 10-point Likert Scale, where 1 indicates "not recovered" and 10 "fully recovered".
Assessed at baseline, 4th week, and 6th week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paulista University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Franciele Marques Vanderlei, PhD, Universidade Estadual Paulista - FCT / UNESP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 680075683140

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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