NCT03942510

Brief Summary

Introduction: Studies on resistance training (RT) associated with blood flow restriction (BFR) have emerged as an alternative method of gaining strength and hypertrophy; however, the cardiovascular and autonomic repercussion of BFR at different intensities is unknown. Thus, it becomes relevant to investigate this type of training in post-exercise. Objective: investigate and compare autonomic and hemodynamic responses of acute 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 dinamometer isokinetic 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, the recovery heart rate (HRR) in the 1st (HRR1) and 2nd (HRR2) minute, rMSSD of 30 seconds, the hemodynamic parameters (heart rate, systolic and diastolic blood pressure, respiratory rate, peripheral oxygen saturation and rate pressure product) and heart rate variability (HRV) indices analyzed in the time domain (mean HR, rMSSD and SDNN), frequency domain (LF and HF \[nu and ms2\]) and Poincaré plot (SD1 and SD2). The analysis will be occur on baseline, immediately e after the excentric exercise and in the post exercise period for 60 minutes. Descriptive statistics method and comparison of HRV indices and hemodynamic parameters between moments and groups will be performed with the aid of the analysis of variance technique for the repetitive measures model without the schema of two sets of tests to follow . The level of significance will be p \<0.05.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

April 30, 2019

Last Update Submit

March 8, 2021

Conditions

Keywords

resistance trainingvascular occlusionhemodynamics, cardiovascular systemautonomic nervous systemheart raterecovery of physiological function

Outcome Measures

Primary Outcomes (5)

  • heart rate variability indices in the time domain

    mean HR, rMSSD and SDNN in ms

    Change from baseline at 3rd week and 6rd week

  • heart rate variability indices analyzed in the Poincaré plot

    SD1 and SD2 in ms

    Change from baseline at 3rd week and 6rd week

  • heart rate variability indices in the frequency domain

    LF and HF in nu and ms2

    Change from baseline at 3rd week and 6rd week

  • vagal reentry

    rMSSD of 30 seconds in ms

    Change from 1 day at 10 day and 18 day

  • heart rate recovery

    the recovery heart rate (HRR) in the 1st (HRR1) and 2st (HRR2) minute \[bpm\]

    Change from 1 day at 10 day and 18 day

Secondary Outcomes (4)

  • hemodynamic parameter

    through study completion, an average of 6 weeks

  • hemodynamic parameter

    through study completion, an average of 6 weeks

  • hemodynamic parameter

    through study completion, an average of 6 weeks

  • hemodynamic parameter

    through study completion, an average of 6 weeks

Study Arms (4)

High intensity eccentric training

EXPERIMENTAL

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: eccentric exercise with blood flow restriction

High intensity eccentric training with blood flow restriction

EXPERIMENTAL

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.

Other: eccentric exercise with blood flow restriction

Low intensity eccentric training

EXPERIMENTAL

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: eccentric exercise with blood flow restriction

Low intensity eccentric training with blood flow restriction

EXPERIMENTAL

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.

Other: eccentric exercise with blood flow restriction

Interventions

High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.

High intensity eccentric trainingHigh intensity eccentric training with blood flow restrictionLow intensity eccentric trainingLow intensity eccentric training with blood flow restriction

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leonardo Kesrouani Lemos

Presidente Prudente, São Paulo, 19050-050, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Franciele M Vanderlei, PhD

    Paulista State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 8, 2019

Study Start

March 11, 2019

Primary Completion

October 17, 2019

Study Completion

December 22, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations