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Completed

NCT Number: NCT03942510

Autonomical and Hemodynamic Repercussions on Excentric Resistance in Different Intensities With Blood Flow Restriction

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Leonardo Kesrouani Lemos

Presidente Prudente, São Paulo, 19050-050, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eccentric exercise with blood flow restriction

Other

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

Primary outcomes

  1. heart rate variability indices in the time domain

    Time frame: Change from baseline at 3rd week and 6rd week

    mean HR, rMSSD and SDNN in ms

  2. heart rate variability indices analyzed in the Poincaré plot

    Time frame: Change from baseline at 3rd week and 6rd week

    SD1 and SD2 in ms

  3. heart rate variability indices in the frequency domain

    Time frame: Change from baseline at 3rd week and 6rd week

    LF and HF in nu and ms2

  4. vagal reentry

    Time frame: Change from 1 day at 10 day and 18 day

    rMSSD of 30 seconds in ms

  5. heart rate recovery

    Time frame: Change from 1 day at 10 day and 18 day

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

Secondary outcomes

  1. hemodynamic parameter

    Time frame: through study completion, an average of 6 weeks

    heart rate [bpm]

  2. hemodynamic parameter

    Time frame: through study completion, an average of 6 weeks

    systolic and diastolic blood pressure [mmHg]

  3. hemodynamic parameter

    Time frame: through study completion, an average of 6 weeks

    respiratory rate [irpm]

  4. hemodynamic parameter

    Time frame: through study completion, an average of 6 weeks

    peripheral oxygen saturation [%]

Sponsors and collaborators

Lead sponsor

Paulista University

Other

Registry information

Official study title

Autonomical and Hemodynamic Repercussions on Excentric Resistance in Different Intensities Associated With Blood Flow Restriction: a Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 8, 2019
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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