- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03601104
Effects of Low Intensity, High Intensity Eccentric Resistance Training Associated With Blood Flow Restriction (oclusion)
March 8, 2021 updated by: Franciele Marques Vanderle, Paulista University
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%.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
61
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, 55
- Franciele Marques Vanderlei
-
-
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 |
|---|---|
|
Active Comparator: HIET (n = 15)
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.
|
High intensity eccentric training group with 80% of isometric peak torque.
|
|
Experimental: HIET-BFR (n= 15)
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.
|
Eccentric high intensity training group with 80% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).
|
|
Experimental: LIET-BFR (n = 15)
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.
|
Low intensity eccentric training group with 40% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).
|
|
Active Comparator: LIET (n= 15)
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.
|
Low intensity eccentric training group with 40% of isometric peak torque
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, fourth week and one week after sixth week
|
|
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.
|
baseline, fourth week and one week after sixth week.
|
|
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.
|
baseline, fourth week and one week after sixth week.
|
|
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.
|
baseline, fourth week and one week after sixth week.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain threshold
Time Frame: Assessed at baseline, 4th week, and 6th week.
|
To assess the pain threshold, the pressure algometer will be applied at five specific locations on the quadriceps.
|
Assessed at baseline, 4th week, and 6th week.
|
|
Analog Visual Scale
Time Frame: Assessed at baseline, 4th week, and 6th week.
|
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.
|
Assessed at baseline, 4th week, and 6th week.
|
|
Perceived Effort Scale (Borg)
Time Frame: Assessed at baseline, 4th week, and 6th week.
|
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."
|
Assessed at baseline, 4th week, and 6th week.
|
|
Recovery Perception Scale
Time Frame: Assessed at baseline, 4th week, and 6th week.
|
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".
|
Assessed at baseline, 4th week, and 6th week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Franciele Marques Vanderlei, PhD, Universidade Estadual Paulista - FCT / UNESP
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 12, 2019
Primary Completion (Actual)
May 12, 2019
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 21, 2018
First Submitted That Met QC Criteria
July 17, 2018
First Posted (Actual)
July 26, 2018
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
- 680075683140
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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