Autonomical and Hemodynamic Repercussions on Excentric Resistance in Different Intensities With Blood Flow Restriction
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
April 30, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2020
CompletedMarch 9, 2021
March 1, 2021
7 months
April 30, 2019
March 8, 2021
Conditions
Keywords
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
EXPERIMENTALhigh intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week.
High intensity eccentric training with blood flow restriction
EXPERIMENTALhigh 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.
Low intensity eccentric training
EXPERIMENTALA low intensity (40% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week.
Low intensity eccentric training with blood flow restriction
EXPERIMENTALA 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.
Interventions
High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franciele M Vanderlei, PhD
Paulista State University
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