ExerciseoclusionNCT03601104
Effects of Low Intensity, High Intensity Eccentric Resistance Training Associated With Blood Flow Restriction
A study testing High intensity eccentric training, High intensity eccentric training with BFR and Low intensity eccentric training with BFR in people with Exercise, run by Paulista University at 1 site in Brazil.
Trial summary
Introduction: studies on resistance training of low intensity associated with blood flow restriction in recent years, although there are still gaps that can be explored in relation to their physiological phenomena when associated with eccentric training. 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?
- High intensity eccentric training, High intensity eccentric training with BFR and Low intensity eccentric training with BFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Mar 2019to 31 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.
About this study
Official title: Effects of Low Intensity, High Intensity Eccentric Resistance Training Associated With Blood Flow Restriction: a Randomized Controlled Trial
Introduction: studies on resistance training of low intensity associated with blood flow restriction in recent years, although there are still gaps that can be explored in relation to their physiological phenomena when associated with eccentric training. In this way, from there the exploration becomes relevant the investigation of eccentric training associated to an RFS. Objective: To analyze and compare the effects of a high intensity and low intensity intensive resistance training associated with an RFS (TREAI-RFS and TREBI-RFS) with a high intensity eccentric resistance training without RFS (TREAI) in knee extensors. Method: The study will consist of 45 male participants, allocated from a stratified randomization into three groups: TREAI (n = 15), TREAI-RFS (n = 15) and TREBI-RFS (n = 15). Participants underwent a training program with a minimum of 40% without RFS, 80% with RFS and 40% with CVS of CVIM, 3 times a week, and the outcomes of muscle strength, muscle structure, power test and Endothelial growth will be assessed one week before, the fourth week and one week after the end of the training program. In addition, clinical markers of perception and recovery effort are investigated before and after a session. The graph used is descriptive and descriptive, as it is used as a model of analysis of variance for the analysis of replications without a two-factor scheme, which provides detailed information on how the measures are repeated, neither. A whole statistical analysis can reach the level of significance of 5%.
- Conditions
- Exercise
- Being tested
- High intensity eccentric training, High intensity eccentric training with BFR, Low intensity eccentric training with BFR, Low intensity eccentric training
- Keywords
- Eccentric Training, Resistance Training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity eccentric trainingOther
High intensity eccentric training group with 80% of isometric peak torque.
High intensity eccentric training with BFROther
Eccentric high intensity training group with 80% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).
Low intensity eccentric training with BFROther
Low intensity eccentric training group with 40% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).
Low intensity eccentric trainingOther
Low intensity eccentric training group with 40% of isometric peak torque
| Study group | Role | What they receive |
|---|---|---|
| HIET (n = 15) | Active comparator | High intensity eccentric training: A 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: High intensity eccentric training |
| HIET-BFR (n= 15) | Experimental | High intensity eccentric training with blood flow restriction (BFR): A high intensity eccentric (80% isometric peak) training of the knee extensors in isokinetic will be performed, associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure) for 6 weeks, 3 times a week. Receives: Other: High intensity eccentric training with BFR |
| LIET-BFR (n = 15) | Experimental | Low intensity eccentric training with blood flow restriction (BFR): A low intensity eccentric (40% isometric peak) training of the knee extensors in isokinetic will be performed associated with a pressure cuff placed in the proximal thigh (40% absolute occlusion pressure) for 6 weeks, 3 times a week. Receives: Other: Low intensity eccentric training with BFR |
| LIET (n= 15) | Active comparator | 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. Receives: Other: Low intensity eccentric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle strength torque peaks at dinamometer isokinetic
The isometric, eccentric and concentric torque peaks will be measured with an isokinetic dynamometer in order to evaluate the adaptations of knee extensor force to eccentric training.
Measured: baseline, fourth week and one week after sixth week
Change in muscular structure with ultrasonography
Ultrasonographic imaging of the dominant lower limb will be captured to determine muscle thickness of the vastus lateralis (VL) and rectus femoris (RF) muscles.
Measured: baseline, fourth week and one week after sixth week.
Change in Vascular Endothelial Growth Factor (VEGF)
For the analysis of the concentration of endothelial growth factor (VEGF) will be collected 10 ml of blood sample. The plasma of this sample will be stored at -80 ° C for further analysis.
Measured: baseline, fourth week and one week after sixth week.
Change in muscle power test
The strength and muscle power tests will be performed on a vertical squat with a guided bar.
Measured: baseline, fourth week and one week after sixth week.
Secondary outcomes (4)
Pain threshold
To assess the pain threshold, the pressure algometer will be applied at five specific locations on the quadriceps.
Measured: Assessed at baseline, 4th week, and 6th week.
Analog Visual Scale
The subjective evaluation of pain will be obtained through the Visual Analogue Scale (EVA), graded from 0 to 10, with zero being the total absence of pain and 10 the maximum level of pain supported by the participant.
Measured: Assessed at baseline, 4th week, and 6th week.
Perceived Effort Scale (Borg)
The degree of subjective exertion reported by the participants in relation to the lower limbs will be analyzed by Borg's scale of perception of effort of 6 to 20 points, 6 being "very easy" and 20 being "exhaustive."
Measured: Assessed at baseline, 4th week, and 6th week.
Recovery Perception Scale
The perception of recovery of the lower limb submitted to the eccentric exercise protocol will be evaluated by means of a 10-point Likert Scale, where 1 indicates "not recovered" and 10 "fully recovered".
Measured: Assessed at baseline, 4th week, and 6th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start12 Mar 2019
- Primary completion12 May 2019
- Study completion31 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
- 61 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 Marques Vanderlei, PhD, Principal investigator, Universidade Estadual Paulista - FCT / UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601104
- Sponsor's protocol ID
- 680075683140
- Acronym
- oclusion
- Status last verified
- Mar 2021
- First submitted
- 21 Jun 2018
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Effects of Low Intensity, High Intensity Eccentric Resistance Training Associated With Blood Flow Restriction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03601104
- Acronym / sponsor ID
- oclusion / 680075683140
- Conditions
- Exercise
- Keywords
- Eccentric Training, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Paulista UniversityUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Jul 2018 (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 of low intensity associated with blood flow restriction in recent years, although there are still gaps that can be explored in relation to their physiological phenomena when associated with eccentric training. In this way, from there the exploration becomes relevant the investigation of eccentric training associated to an RFS. Objective: To analyze and compare the effects of a high intensity and low intensity intensive resistance training associated with an RFS (TREAI-RFS and TREBI-RFS) with a high intensity eccentric resistance training without RFS (TREAI) in knee extensors. Method: The study will consist of 45 male participants, allocated from a stratified randomization into three groups: TREAI (n = 15), TREAI-RFS (n = 15) and TREBI-RFS (n = 15). Participants underwent a training program with a minimum of 40% without RFS, 80% with RFS and 40% with CVS of CVIM, 3 times a week, and the outcomes of muscle strength, muscle structure, power test and Endothelial growth will be assessed one week before, the fourth week and one week after the end of the training program. In addition, clinical markers of perception and recovery effort are investigated before and after a session. The graph used is descriptive and descriptive, as it is used as a model of analysis of variance for the analysis of replications without a two-factor scheme, which provides detailed information on how the measures are repeated, neither. A whole statistical analysis can reach the level of significance of 5%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIET (n = 15) | Active comparator | Other: High intensity eccentric trainingHigh intensity eccentric training: A high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week. |
| HIET-BFR (n= 15) | Experimental | Other: High intensity eccentric training with BFRHigh intensity eccentric training with blood flow restriction (BFR): A high intensity eccentric (80% isometric peak) training of the knee extensors in isokinetic will be performed, associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure) for 6 weeks, 3 times a week. |
| LIET-BFR (n = 15) | Experimental | Other: Low intensity eccentric training with BFRLow intensity eccentric training with blood flow restriction (BFR): A low intensity eccentric (40% isometric peak) training of the knee extensors in isokinetic will be performed associated with a pressure cuff placed in the proximal thigh (40% absolute occlusion pressure) for 6 weeks, 3 times a week. |
| LIET (n= 15) | Active comparator | Other: Low intensity eccentric trainingLow 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. |
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 |
|---|---|---|
| High intensity eccentric trainingHigh intensity eccentric training group with 80% of isometric peak torque. | Other | HIET (n = 15) |
| High intensity eccentric training with BFREccentric high intensity training group with 80% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure). | Other | HIET-BFR (n= 15) |
| Low intensity eccentric training with BFRLow intensity eccentric training group with 40% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure). | Other | LIET-BFR (n = 15) |
| Low intensity eccentric trainingLow intensity eccentric training group with 40% of isometric peak torque | Other | LIET (n= 15) |
Primary outcome
Change in muscle strength torque peaks at dinamometer isokinetic
Time frame: baseline, fourth week and one week after sixth week
The isometric, eccentric and concentric torque peaks will be measured with an isokinetic dynamometer in order to evaluate the adaptations of knee extensor force to eccentric training.
Change in muscular structure with ultrasonography
Time frame: baseline, fourth week and one week after sixth week.
Ultrasonographic imaging of the dominant lower limb will be captured to determine muscle thickness of the vastus lateralis (VL) and rectus femoris (RF) muscles.
Change in Vascular Endothelial Growth Factor (VEGF)
Time frame: baseline, fourth week and one week after sixth week.
For the analysis of the concentration of endothelial growth factor (VEGF) will be collected 10 ml of blood sample. The plasma of this sample will be stored at -80 ° C for further analysis.
Change in muscle power test
Time frame: baseline, fourth week and one week after sixth week.
The strength and muscle power tests will be performed on a vertical squat with a guided bar.
4 secondary outcomes
Pain threshold
Time frame: Assessed at baseline, 4th week, and 6th week.
Analog Visual Scale
Time frame: Assessed at baseline, 4th week, and 6th week.
Perceived Effort Scale (Borg)
Time frame: Assessed at baseline, 4th week, and 6th week.
Recovery Perception Scale
Time frame: Assessed at baseline, 4th week, and 6th week.
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 Marques Vanderlei, PhD principal investigator
Universidade Estadual Paulista - FCT / UNESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity eccentric training, High intensity eccentric training with BFR and Low intensity eccentric training with BFR 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?
Change in muscle strength torque peaks at dinamometer isokinetic (time frame: baseline, fourth week and one week after sixth week). The study lists 4 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.