NCT03601104

Brief 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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

June 21, 2018

Last Update Submit

March 8, 2021

Conditions

Keywords

Eccentric TrainingResistance Training

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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.

  • 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.

  • 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 Outcomes (4)

  • Pain threshold

    Assessed at baseline, 4th week, and 6th week.

  • Analog Visual Scale

    Assessed at baseline, 4th week, and 6th week.

  • Perceived Effort Scale (Borg)

    Assessed at baseline, 4th week, and 6th week.

  • Recovery Perception Scale

    Assessed at baseline, 4th week, and 6th week.

Study Arms (4)

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.

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.

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.

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.

Other: Low intensity eccentric training

Interventions

High intensity eccentric training group with 80% of isometric peak torque.

HIET (n = 15)

Eccentric high intensity training group with 80% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).

HIET-BFR (n= 15)

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

LIET-BFR (n = 15)

Low intensity eccentric training group with 40% of isometric peak torque

LIET (n= 15)

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male sex;
  • healthy;
  • aged between 18 and 35 years

You may not qualify if:

  • smokers;
  • alcoholics;
  • use drugs that influenced cardiac autonomic activity;
  • cardiovascular, metabolic or endocrine diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franciele Marques Vanderlei

Presidente Prudente, São Paulo, 55, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Franciele Marques Vanderlei, PhD

    Universidade Estadual Paulista - FCT / UNESP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 26, 2018

Study Start

March 12, 2019

Primary Completion

May 12, 2019

Study Completion

December 31, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Locations