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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03601104
Other study ID # 680075683140
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 12, 2019
Est. completion date December 31, 2020

Study information

Verified date March 2021
Source Paulista University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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%.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 31, 2020
Est. primary completion date May 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
High intensity eccentric training
High intensity eccentric training group with 80% of isometric peak torque.
High intensity eccentric training with BFR
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 BFR
Low intensity eccentric training group with 40% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).
Low intensity eccentric training
Low intensity eccentric training group with 40% of isometric peak torque

Locations

Country Name City State
Brazil Franciele Marques Vanderlei Presidente Prudente SP

Sponsors (1)

Lead Sponsor Collaborator
Paulista University

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline, fourth week and one week after sixth week
Primary 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. baseline, fourth week and one week after sixth week.
Primary 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. baseline, fourth week and one week after sixth week.
Primary Change in muscle power test 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 Pain threshold 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.
Secondary 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. Assessed at baseline, 4th week, and 6th week.
Secondary 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." Assessed at baseline, 4th week, and 6th week.
Secondary 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". Assessed at baseline, 4th week, and 6th week.
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