NCT03653286

Brief Summary

Introduction: The use of neuromuscular electrical stimulation (NMES) in athlete training has become an increasingly common feature among competition teams. Among the main benefits of NMES are the increase in muscular strength and improvement in athletes' performance. Surveys demonstrate the benefits of basketball, volleyball, soccer, swimmers and Olympic lifters using NMES, but no studies have been conducted on runners. Objectives: To evaluate the effects of 6 weeks of training with NMES, on knee peak torque (PT), ventilatory anaerobic threshold, maximum oxygen consumption (VO2max) and running economy in recreational runners. Methods: Randomized clinical trial involving 30 long distance runners, being randomly distributed in 2 groups of 15 participants each. All individuals will perform isokinetic evaluation of the lower limbs and ergospirometry. After these evaluations, all athletes will perform the same running training (CT), in addition to the CT the intervention group will perform NMES on the knee extensors 3 times a week for 15 minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

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

August 26, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

September 19, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2019

Completed
Last Updated

November 5, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

August 26, 2018

Last Update Submit

November 2, 2019

Conditions

Keywords

Neuromuscular Eletrical StimulationTorqueRunners

Outcome Measures

Primary Outcomes (1)

  • Isokinetic dynamometer

    The computerized isokinetic muscle evaluation will be performed in the Cybex Norm isokinetic dynamometer (Cybex International, Inc., Ronkonkoma, LI, New York), at the Physiotherapy Clinic of Universidade Cidade de São Paulo (UNICID). The movement performed during the test will be that of isometric, concentric and eccentric extension of the two knees, to measure peak torque, using angulations of 90 to 60 degrees of knee and 3 maximum voluntary contractions.

    6 weeks

Secondary Outcomes (3)

  • Maximum oxygen consumption

    6 weeks

  • Racing economy

    6 weeks

  • Analysis of Ventilatory Anaerobic Threshold

    6 weeks

Study Arms (2)

NMES and Run

EXPERIMENTAL

NMES and run

Other: NMES and Run

Only Run

OTHER

Only Run

Other: Only Run

Interventions

NMESIn this exercise protocol for quadriceps strengthening using NMES, the medium-frequency alternating current (1KHz with 10% of the work cycle) 4 will be used. The total daily training time is 900sec (15min), it is expected to perform 45 contractions per training, with three workouts per week for six weeks. RUN: It will be allowed to carry out training drills that comprise 15-40Km per week, being allowed a minimum of 2 and a maximum of 3 training sessions per week, not being able to carry out drills of explosion and during each training must be covered at least 5km and at most 15km. These limitations were based on the American College of Sports Medicine (ACSM) cardiorespiratory training guidelines to minimize confounders of cardiopulmonary performance.

NMES and Run

RUN: It will be allowed to carry out training drills that comprise 15-40Km per week, being allowed a minimum of 2 and a maximum of 3 training sessions per week, not being able to carry out drills of explosion and during each training must be covered at least 5km and at most 15km. These limitations were based on the American College of Sports Medicine (ACSM) cardiorespiratory training guidelines to minimize confounders of cardiopulmonary performance.

Only Run

Eligibility Criteria

Age30 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIncluded will be male individuals, aged 30 to 45 years, recreational runners, who have been performing the activity for at least 1 year, totaling at least 15km and a maximum of 40km of training per week, who do not use NMES for the purpose of muscle training. Subjects who suffer muscle injuries and / or joint injuries in the lower limbs (LMW) during the 6 weeks of training, Subjects who present muscle injuries and / or joint injuries in the lower limbs (LMI) in the last 6 months can't be part of the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Included will be male individuals, aged 30 to 45 years
  • recreational funders, who have been performing the activity for at least 1 year.
  • Totaling at least 15km and a maximum of 40km of training per week,
  • Who do not use NMES for the purpose of muscle training.

You may not qualify if:

  • Subjects who present muscle injuries and / or joint injuries in the lower limbs (LMI) in the last 6 months can't be part of the study.
  • Who are unable to perform the isokinetic test
  • Who are unable to do ergospirometric test,
  • Who meet the contraindications criteria of NMES

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNICID

São Paulo, São Paulo, 03071-000, Brazil

Location

MeSH Terms

Interventions

Jogging

Intervention Hierarchy (Ancestors)

RunningLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Richard E Liebano

    Universidade Cidade de Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigations of the peak muscle torque, analysis of ventilatory anaerobic thresholds, running economy and maximal oxygen consumption will be performed by a blind investigator. Data analysis will be performed by a blind investigator in the control and intervention groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The runners will be randomized into two groups, being: control group (CG) - will perform only run and intervention group (GI) - using the medium-frequency alternating current and run.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2018

First Posted

August 31, 2018

Study Start

September 19, 2018

Primary Completion

July 25, 2019

Study Completion

September 21, 2019

Last Updated

November 5, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations