- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03942510
Autonomical and Hemodynamic Repercussions on Excentric Resistance in Different Intensities With Blood Flow Restriction
March 8, 2021 updated by: Franciele Marques Vanderle, Paulista University
Autonomical and Hemodynamic Repercussions on Excentric Resistance in Different Intensities Associated With Blood Flow Restriction: a Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Presidente Prudente, SP, Brazil, 19050-050
- Leonardo Kesrouani Lemos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from baseline at 3rd week and 6rd week
|
|
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
|
Change from baseline at 3rd week and 6rd week
|
|
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
|
Change from baseline at 3rd week and 6rd week
|
|
vagal reentry
Time Frame: Change from 1 day at 10 day and 18 day
|
rMSSD of 30 seconds in ms
|
Change from 1 day at 10 day and 18 day
|
|
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]
|
Change from 1 day at 10 day and 18 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hemodynamic parameter
Time Frame: through study completion, an average of 6 weeks
|
heart rate [bpm]
|
through study completion, an average of 6 weeks
|
|
hemodynamic parameter
Time Frame: through study completion, an average of 6 weeks
|
systolic and diastolic blood pressure [mmHg]
|
through study completion, an average of 6 weeks
|
|
hemodynamic parameter
Time Frame: through study completion, an average of 6 weeks
|
respiratory rate [irpm]
|
through study completion, an average of 6 weeks
|
|
hemodynamic parameter
Time Frame: through study completion, an average of 6 weeks
|
peripheral oxygen saturation [%]
|
through study completion, an average of 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Franciele M Vanderlei, PhD, Paulista State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2019
Primary Completion (Actual)
October 17, 2019
Study Completion (Actual)
December 22, 2020
Study Registration Dates
First Submitted
April 30, 2019
First Submitted That Met QC Criteria
May 6, 2019
First Posted (Actual)
May 8, 2019
Study Record Updates
Last Update Posted (Actual)
March 9, 2021
Last Update Submitted That Met QC Criteria
March 8, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- U1111-1232-0808
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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