Neuromuscular Eletroestimulation in Torque for Long Distance Recreational Runners

NCT ID: NCT03653286

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2019-09-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants who meet the eligibility criteria will be invited to participate in the study and, after signing the informed consent form, will perform initial clinical evaluation and will be randomized into two groups, being: control group (CG) and intervention group (GI) - using the medium-frequency alternating current. Each group will consist of 15 subjects who will have as dependent variables, the evaluation of the following items: peak muscle torque, analysis of ventilatory anaerobic thresholds, running economy and maximal oxygen consumption.

The intervention with the NMES will be considered as an independent variable. All groups will have the dependent variables evaluated before and after the intervention, which will consist of 18 sessions (6 weeks). The NMES training will be performed 3 times a week and will never be applied for two consecutive days, as shown in the flowchart All individuals, being they of the CG or the GI will perform a running training (TC), between 15 and 40 km per week and will be guided how to perform them, and the GI patients will perform a muscle strengthening protocol with NMES, which will be carried out in a specific place and prepared for intervention, in addition to the TC.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Torque

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NMES and Run

NMES and run

Group Type EXPERIMENTAL

NMES and Run

Intervention Type OTHER

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.

Only Run

Only Run

Group Type OTHER

Only Run

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NMES and Run

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.

Intervention Type OTHER

Only 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Richard Eloin Liebano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard E Liebano

Role: STUDY_DIRECTOR

Universidade Cidade de Sao Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UNICID

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UNICIDAGRREM14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NMES and Chronic Ankle Instability
NCT04322409 UNKNOWN PHASE1