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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 [%]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Brazil

Leonardo Kesrouani Lemos

Presidente Prudente, SP, Brazil, 19050-050

Sponsors and Collaborators

Paulista University

Investigators

• Principal Investigator: Franciele M Vanderlei, PhD; Paulista State University

More Information

• 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
• Last Update Posted: September 16, 2020
• Last Verified: September 2020

• 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