ExerciseNCT04422301
Correlation Between HRV and Performance in Eccentric Resistance Training Associated With Partial Blood Flow Restriction
A study testing Blood flow restriction in people with Exercise, run by Franciele Marques Vanderle at 1 site in Brazil.
Trial summary
Studies on resistance training (RT) associated with blood flow restriction (BFR) is an alternative method of gaining strength and hypertrophy muscle. However, there is a gap correlated to autonomic repercussion of BFR and performance. Thus, it becomes relevant to investigate this type of training in post-exercise. 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?
- Blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 18 May 2021to 18 Jun 2021
- 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.
About this study
Official title: Correlation Between Heart Rate Variability and Performance in Eccentric Resistance Training Associated With Partial Blood Flow Restriction: a Randomized Clinical Trial
Studies on resistance training (RT) associated with blood flow restriction (BFR) is an alternative method of gaining strength and hypertrophy muscle. However, there is a gap correlated to autonomic repercussion of BFR and performance. Thus, it becomes relevant to investigate this type of training in post-exercise. Objective: investigate and compare autonomic and performance responses of 6 weeks of 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 isokinetic dynamometry 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, it will be used: the root-mean-square of the successive normal sinus RR interval difference (rMSSD); high frequency (HF) ms²; HF(nu) and the standard deviation of instantaneous beat-to-beat interval variability (SD1). For performance, it will be used the single leg hop test.
For data analysis of the population profile, the descriptive statistical method will be used and the results will be presented with values of means, standard deviations, median and confidence interval. Initially, participants from all study groups will be dichotomized at each performance outcome (muscle strength test on the isokinetic dynamometer and vertical jump test) as "improvement" or "without improvement" in order to demonstrate the behavior of the responses obtained during the training, that is, whether the individual responded to the RT or not. It is worth mentioning that this qualitative analysis will be performed considering the data obtained from the initial, intermediate and final evaluation.
Read more
The dichotomization of the results of the functional tests will be performed by the typical error of the sample measurement for each test. It will be considered as "improvement" if the participant presents gains in tests above the typical error of the measure. The values obtained from the initial, intermediate and final evaluation will be analyzed independently.
Subsequently, the weekly average of the vagal indices (rMSSD, HF and SD1) will be performed in the baseline moment and after 6 weeks of RT moment of each study group. In the sequence, the performance parameters will be correlated with the autonomic parameters in the respective groups. Pearson or Spearman correlation test will be used according to the normality of the data. The level of significance will be p <0.05 for all tests. The statistical program SPSS (Statistical Package for the Social Sciences) will be used for the analyzes.
- Conditions
- Exercise
- Being tested
- Blood flow restriction
- Keywords
- resistance training, vascular occlusion, performance, autonomic nervous system, 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.
Blood flow restrictionOther
an alternative method to produce strength and muscle hypertrophy with lower intensities
| Study group | Role | What they receive |
|---|---|---|
| High intensity eccentric training | 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.
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. Receives: Other: Blood flow restriction |
| High intensity eccentric training with 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. 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 Receives: Other: 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. 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. Receives: Other: 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. 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. Receives: Other: Blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Single Leg Hop Test
Measured: Baseline
Performance
Single Leg Hop Test
Measured: up to 3 weeks
Performance
Single Leg Hop Test
Measured: after 6 weeks from baseline.
HRV - rMSSD
rMSSD (square root of the mean squared differences of successive N-N intervals)
Measured: during the 6 weeks of training
HRV - SD1
SD1 - the standard deviation of instantaneous beat-to-beat interval variability
Measured: during the 6 weeks of training
HRV - HF (ms²)
HF (ms²) - (high frequency)
Measured: during the 6 weeks of training
HRV -HF (nu)
HF (nu) - (high frequency)
Measured: during the 6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start18 May 2021
- Primary completion18 Jun 2021
- Study completion18 Jun 2021
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
- Franciele Marques Vanderle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franciele Marques Vanderle, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422301
- Sponsor's protocol ID
- Unesp
- Status last verified
- Aug 2021
- First submitted
- 1 Jun 2020
- Last updated
- 31 Aug 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Heart Rate Variability and Performance in Eccentric Resistance Training Associated With Partial Blood Flow Restriction: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04422301
- Acronym / sponsor ID
- Unesp
- Conditions
- Exercise
- Keywords
- resistance training, vascular occlusion, performance, autonomic nervous system, recovery of physiological function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Franciele Marques VanderleUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 9 Jun 2020 (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.
Studies on resistance training (RT) associated with blood flow restriction (BFR) is an alternative method of gaining strength and hypertrophy muscle. However, there is a gap correlated to autonomic repercussion of BFR and performance. Thus, it becomes relevant to investigate this type of training in post-exercise. Objective: investigate and compare autonomic and performance responses of 6 weeks of 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 isokinetic dynamometry 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, it will be used: the root-mean-square of the successive normal sinus RR interval difference (rMSSD); high frequency (HF) ms²; HF(nu) and the standard deviation of instantaneous beat-to-beat interval variability (SD1). For performance, it will be used the single leg hop test.
For data analysis of the population profile, the descriptive statistical method will be used and the results will be presented with values of means, standard deviations, median and confidence interval. Initially, participants from all study groups will be dichotomized at each performance outcome (muscle strength test on the isokinetic dynamometer and vertical jump test) as "improvement" or "without improvement" in order to demonstrate the behavior of the responses obtained during the training, that is, whether the individual responded to the RT or not. It is worth mentioning that this qualitative analysis will be performed considering the data obtained from the initial, intermediate and final evaluation.
The dichotomization of the results of the functional tests will be performed by the typical error of the sample measurement for each test. It will be considered as "improvement" if the participant presents gains in tests above the typical error of the measure. The values obtained from the initial, intermediate and final evaluation will be analyzed independently.
Subsequently, the weekly average of the vagal indices (rMSSD, HF and SD1) will be performed in the baseline moment and after 6 weeks of RT moment of each study group. In the sequence, the performance parameters will be correlated with the autonomic parameters in the respective groups. Pearson or Spearman correlation test will be used according to the normality of the data. The level of significance will be p <0.05 for all tests. The statistical program SPSS (Statistical Package for the Social Sciences) will be used for the analyzes.
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: Blood flow restrictionHigh 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. 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. |
| High intensity eccentric training with blood flow restriction | Experimental | Other: Blood flow restrictionHigh 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. 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 |
| Low intensity eccentric training | Experimental | Other: 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. 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. |
| Low intensity eccentric training with blood flow restriction | Experimental | Other: 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. 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. |
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 |
|---|---|---|
| Blood flow restrictionan alternative method to produce strength and muscle hypertrophy with lower intensities | 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
Performance
Time frame: Baseline
Single Leg Hop Test
Performance
Time frame: up to 3 weeks
Single Leg Hop Test
Performance
Time frame: after 6 weeks from baseline.
Single Leg Hop Test
HRV - rMSSD
Time frame: during the 6 weeks of training
rMSSD (square root of the mean squared differences of successive N-N intervals)
HRV - SD1
Time frame: during the 6 weeks of training
SD1 - the standard deviation of instantaneous beat-to-beat interval variability
HRV - HF (ms²)
Time frame: during the 6 weeks of training
HF (ms²) - (high frequency)
HRV -HF (nu)
Time frame: during the 6 weeks of training
HF (nu) - (high frequency)
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 31 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction in people with Exercise, run by Franciele Marques Vanderle 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 31 Aug 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?
Performance (time frame: Baseline). The study lists 7 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 31 Aug 2021.