Correlation Between HRV and Performance in Eccentric Resistance Training Associated With Partial Blood Flow Restriction

August 30, 2021 updated by: Franciele Marques Vanderle

Correlation Between Heart Rate Variability and Performance in Eccentric Resistance Training Associated With Partial Blood Flow Restriction: a Randomized Clinical Trial

Studies on resistance training (RT) associated with blood flow restriction (BFR) is an alternative method of gaining strength and hypertrophy muscle. However, there is a gap correlated to autonomic repercussion of BFR and performance. Thus, it becomes relevant to investigate this type of training in post-exercise. Objective: investigate and compare autonomic and performance responses of 6 weeks of eccentric RT with different intensities associated or not to BFR in healthy youngsters. Method: This is a randomized clinical trial including 60 healthy men aged 18-35 years, divided into four groups according to exercise intensity and BFR: 80% without BFR, 40% without BFR, 80% with BFR and 40% with BFR. Exercise intensity will be determined by the peak of excentric torque on the isokinetic dynamometry method and by the BFR, as being 40% of the intensity required for the complete examination of the blood flow evaluated by Doppler. Participants will do an eccentric femoral quadriceps muscle exercise session on the isokinetic dynamometer according to the previously randomized group. For recovery analyzes, it will be used: the root-mean-square of the successive normal sinus RR interval difference (rMSSD); high frequency (HF) ms²; HF(nu) and the standard deviation of instantaneous beat-to-beat interval variability (SD1). For performance, it will be used the single leg hop test.

For data analysis of the population profile, the descriptive statistical method will be used and the results will be presented with values of means, standard deviations, median and confidence interval. Initially, participants from all study groups will be dichotomized at each performance outcome (muscle strength test on the isokinetic dynamometer and vertical jump test) as "improvement" or "without improvement" in order to demonstrate the behavior of the responses obtained during the training, that is, whether the individual responded to the RT or not. It is worth mentioning that this qualitative analysis will be performed considering the data obtained from the initial, intermediate and final evaluation.

The dichotomization of the results of the functional tests will be performed by the typical error of the sample measurement for each test. It will be considered as "improvement" if the participant presents gains in tests above the typical error of the measure. The values obtained from the initial, intermediate and final evaluation will be analyzed independently.

Subsequently, the weekly average of the vagal indices (rMSSD, HF and SD1) will be performed in the baseline moment and after 6 weeks of RT moment of each study group. In the sequence, the performance parameters will be correlated with the autonomic parameters in the respective groups. Pearson or Spearman correlation test will be used according to the normality of the data. The level of significance will be p <0.05 for all tests. The statistical program SPSS (Statistical Package for the Social Sciences) will be used for the analyzes.

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

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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.
60

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

Yes

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.
Experimental: High intensity eccentric training

High intensity eccentric training high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week.

eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
Other: Blood flow restriction
an alternative method to produce strength and muscle hypertrophy with lower intensities
Experimental: High intensity eccentric training with blood flow restriction
High intensity eccentric training with blood flow restriction high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure) will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction
Other: Blood flow restriction
an alternative method to produce strength and muscle hypertrophy with lower intensities
Experimental: 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. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
Other: Blood flow restriction
an alternative method to produce strength and muscle hypertrophy with lower intensities
Experimental: Low intensity eccentric training with blood flow restriction
A low intensity (40% isometric peak) eccentric training of the knee extensors in the isokinetic associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure)will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
Other: Blood flow restriction
an alternative method to produce strength and muscle hypertrophy with lower intensities

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
Performance
Time Frame: Baseline
Single Leg Hop Test
Baseline
Performance
Time Frame: up to 3 weeks
Single Leg Hop Test
up to 3 weeks
Performance
Time Frame: after 6 weeks from baseline.
Single Leg Hop Test
after 6 weeks from baseline.
HRV - rMSSD
Time Frame: during the 6 weeks of training
rMSSD (square root of the mean squared differences of successive N-N intervals)
during the 6 weeks of training
HRV - SD1
Time Frame: during the 6 weeks of training
SD1 - the standard deviation of instantaneous beat-to-beat interval variability
during the 6 weeks of training
HRV - HF (ms²)
Time Frame: during the 6 weeks of training
HF (ms²) - (high frequency)
during the 6 weeks of training
HRV -HF (nu)
Time Frame: during the 6 weeks of training
HF (nu) - (high frequency)
during the 6 weeks of training

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.
Franciele Marques Vanderle

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.
May 18, 2021

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.
June 18, 2021

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.
June 18, 2021

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 1, 2020

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.
June 4, 2020

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.
June 9, 2020

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.
August 31, 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.
August 30, 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.
August 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.
  • Unesp

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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