Autonomic Modulation Recovery After Acute Resistance Exercise

September 23, 2020 updated by: Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho

Autonomic Modulation Recovery After Acute Resistance Exercise in Different Intensities and Body Segments

To analyze the autonomic behavior in recovery post-acute resistance exercise performed in different intensities and body segments.

Study Overview

Status

Status

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

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Detailed Description

Resistance training (RT) is recommended to people with different health condition. RT is recognized as safe and effective method of increasing muscle strength, physical fitness, muscle mass, and overall cardiovascular health. The magnitude of the RT effects is associated with the structure of the training program. Understanding these aspects may provide guidance for the RT prescription while reducing potential risk of cardiovascular events associated with the recovery period after exercise. The objective of the study is to compare the acute responses of the Autonomic Nervous System post RT performed with different intensities (endurance and strength) in different body segments (UL and LL). Our hypothesis is that different intensities and body segments influence the acute responses of the ANS in the post RT recovery period.

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.
49

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, 19060-900
        • Luiz Carlos Marques Vanderlei
    • São Paulo
      • Presidente Prudente, São Paulo, Brazil, 19060900
        • Universidade Estadual Paulista Julio de Mesquita Filho

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 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Graduate students,
  • Age between 18 to 30 years
  • Healthy men, the Physical Activity Readiness Questionnaire (PAR-Q) was used to determine safety and possible risk of exercising based on participants' health history, the according American College of Sports Medicine, 2010.
  • Trained men, the International Physical Activity Questionnaire (IPAQ) was used to determine participants' physical activity level.

Exclusion Criteria: Participants who did not attend all the RT protocols and those with HR record with error higher than 5% (ectopic beats) will be excluded.

-

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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: upper limb endurance protocol
UL endurance protocol - elbow flexion
Other: Resistance Training - UL endurance protocol
UL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).
Active Comparator: upper limb strength protocol
UL strength protocol - elbow flexion
Other: Resistance Training - UL strength protocol
UL strength protocol - 2 series of 8 repetitions, elbow flexion at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).
Active Comparator: lower limb endurance protocol
LL endurance protocol - knee extension
Other: Resistance Training - LL endurance protocol
LL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test strength of 1 maximum repetition, (recovery 1 minutes between sets).
Active Comparator: lower limb strength protocol
LL strength protocol - knee extension
Other: Resistance Training - LL strength protocol
LL strength protocol - 2 series of 8 repetitions, knee extension at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).

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
Acute responses of the Autonomic Nervous System post Resistance Training of the time-domain indices of Heart Rate Variability
Time Frame: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).

Understand the effect of acute responses of the time-domain indices of Heart Rate Variability, RMSSD, and SDNN, comparing the behavior of these indices of in rest periods and immediate recovery after effort. Besides, to analyze the changes observed when applying different training intensities (endurance protocol 40% 1RM, and strength protocol 80% 1 RM) and body segments (elbow flexion [UL] and knee extension [LL]).

RMSSD: root mean square of the successive differences between the RR intervals in the record, divided by the number of RR intervals in a given time minus one RR interval SDNN: standard deviation of all normal RR intervals.
the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).
Acute responses of the Autonomic Nervous System post Resistance Training of the geometric indices of Heart Rate Variability
Time Frame: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).

Understand the effect of acute responses of the geometric indices of Heart Rate Variability, SD1, SD2, comparing the behavior of these indices of in rest periods and immediate recovery after effort. Besides, to analyze the changes observed when applying different training intensities (endurance protocol 40% 1RM, and strength protocol 80% 1 RM) and body segments (elbow flexion [UL] and knee extension [LL]).

SD1: standard deviation of diagonal points SD2: standard deviation from longitudinal points
the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).
Acute responses of the Autonomic Nervous System post Resistance Training of the frequency domain of Heart Rate Variability,
Time Frame: the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).

Understand the effect of acute responses of the frequency domain of Heart Rate Variability, LF anf HF, both calculated in absolute (ms2) and normalized units (nu), comparing the behavior of these indices of in rest periods and immediate recovery after effort. Besides, to analyze the changes observed when applying different training intensities (endurance protocol 40% 1RM, and strength protocol 80% 1 RM) and body segments (elbow flexion [UL] and knee extension [LL]).

LF: spectral components of low frequency, 0.04 - 0.15Hz HF: spectral components of high frequency, 0.15 - 0.40 Hz
the moments before and immediately after Resistance Training, performed with different intensities (endurance and strength) and body segments (UL and LL).

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.
Universidade Estadual Paulista Júlio de Mesquita Filho

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.
  • Study Director: Luiz Carlos M Vanderlei, Professor, Universidade Estadual Paulista - FCT/UNESP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
August 1, 2011

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.
November 30, 2012

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.
January 20, 2015

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).
August 28, 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.
September 23, 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.
September 30, 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.
September 30, 2020

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.
September 23, 2020

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.
September 1, 2020

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.
  • 34303014.6.0000.5515

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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