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

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ClinicalTrials.gov Identifier: NCT03942510
Recruitment Status : Active, not recruiting
First Posted : May 8, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Franciele Marques Vanderle, Paulista University

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.

Condition or disease Intervention/treatment Phase
Exercise Other: eccentric exercise with blood flow restriction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Autonomical and Hemodynamic Repercussions on Excentric Resistance in Different Intensities Associated With Blood Flow Restriction: a Randomized Clinical Trial
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : October 17, 2019
Estimated Study Completion Date : December 22, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.

Experimental: 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.
Other: 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.

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.
Other: 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.

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.
Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 [%]



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942510


Locations
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Brazil
Leonardo Kesrouani Lemos
Presidente Prudente, SP, Brazil, 19050-050
Sponsors and Collaborators
Paulista University
Investigators
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Principal Investigator: Franciele M Vanderlei, PhD Paulista State University
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Responsible Party: Franciele Marques Vanderle, Principal Investigator, Paulista University
ClinicalTrials.gov Identifier: NCT03942510    
Other Study ID Numbers: U1111-1232-0808
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franciele Marques Vanderle, Paulista University:
resistance training
vascular occlusion
hemodynamics, cardiovascular system
autonomic nervous system
heart rate
recovery of physiological function