ExerciseNCT03942510
Autonomical and Hemodynamic Repercussions on Excentric Resistance in Different Intensities With Blood Flow Restriction
A study testing eccentric exercise with blood flow restriction in people with Exercise, run by Paulista University at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- eccentric exercise with blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Mar 2019to 22 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male sex;
- healthy;
- aged between 18 and 35 years
Who cannot join
- smokers;
- alcoholics;
- use drugs that influenced cardiac autonomic activity;
- cardiovascular, metabolic or endocrine diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Leonardo Kesrouani Lemos
Presidente Prudente, São Paulo, 19050-050
About this study
Official title: 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.
- Conditions
- Exercise
- Being tested
- eccentric exercise with blood flow restriction
- Keywords
- resistance training, vascular occlusion, hemodynamics, cardiovascular system, autonomic nervous system, heart rate, recovery of physiological function
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eccentric exercise with blood flow restrictionOther
High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
| Study group | Role | What they receive |
|---|---|---|
| High intensity eccentric training | Experimental | high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week. Receives: Other: eccentric exercise with blood flow restriction |
| High intensity eccentric training with blood flow restriction | Experimental | 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. Receives: Other: eccentric exercise with blood flow restriction |
| Low intensity eccentric training | Experimental | 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. Receives: Other: eccentric exercise with blood flow restriction |
| Low intensity eccentric training with blood flow restriction | Experimental | 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. Receives: Other: eccentric exercise with blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability indices in the time domain
mean HR, rMSSD and SDNN in ms
Measured: Change from baseline at 3rd week and 6rd week
heart rate variability indices analyzed in the Poincaré plot
SD1 and SD2 in ms
Measured: Change from baseline at 3rd week and 6rd week
heart rate variability indices in the frequency domain
LF and HF in nu and ms2
Measured: Change from baseline at 3rd week and 6rd week
vagal reentry
rMSSD of 30 seconds in ms
Measured: 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]
Measured: Change from 1 day at 10 day and 18 day
Secondary outcomes (4)
hemodynamic parameter
heart rate [bpm]
Measured: through study completion, an average of 6 weeks
hemodynamic parameter
systolic and diastolic blood pressure [mmHg]
Measured: through study completion, an average of 6 weeks
hemodynamic parameter
respiratory rate [irpm]
Measured: through study completion, an average of 6 weeks
hemodynamic parameter
peripheral oxygen saturation [%]
Measured: through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start11 Mar 2019
- Primary completion17 Oct 2019
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paulista University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franciele Marques Vanderle, Paulista University
- Investigators
- Franciele M Vanderlei, PhD, Principal investigator, Paulista State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942510
- Sponsor's protocol ID
- U1111-1232-0808
- Status last verified
- Mar 2021
- First submitted
- 30 Apr 2019
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomical and Hemodynamic Repercussions on Excentric Resistance in Different Intensities Associated With Blood Flow Restriction: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03942510
- Acronym / sponsor ID
- U1111-1232-0808
- Conditions
- Exercise
- Keywords
- resistance training, vascular occlusion, hemodynamics, cardiovascular system, autonomic nervous system, heart rate, recovery of physiological function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High intensity eccentric training | Experimental | Other: eccentric exercise with blood flow restrictionhigh 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 | Experimental | Other: eccentric exercise with blood flow restrictionhigh 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 | Experimental | Other: eccentric exercise with blood flow restrictionA 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 | Experimental | Other: eccentric exercise with blood flow restrictionA 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male sex;
- healthy;
- aged between 18 and 35 years
Key exclusion criteria (4 listed)
- smokers;
- alcoholics;
- use drugs that influenced cardiac autonomic activity;
- cardiovascular, metabolic or endocrine diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eccentric exercise with blood flow restrictionHigh/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction. | Other | High intensity eccentric training, High intensity eccentric training with blood flow restriction, Low intensity eccentric training, Low intensity eccentric training with blood flow restriction |
Primary outcome
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
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
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
vagal reentry
Time frame: Change from 1 day at 10 day and 18 day
rMSSD of 30 seconds in ms
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]
4 secondary outcomes
hemodynamic parameter
Time frame: through study completion, an average of 6 weeks
hemodynamic parameter
Time frame: through study completion, an average of 6 weeks
hemodynamic parameter
Time frame: through study completion, an average of 6 weeks
hemodynamic parameter
Time frame: through study completion, an average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franciele M Vanderlei, PhD principal investigator
Paulista State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eccentric exercise with blood flow restriction in people with Exercise, run by Paulista University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability indices in the time domain (time frame: Change from baseline at 3rd week and 6rd week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.