NCT03477747

Brief Summary

The aim of this investigation is to analyse the potential benefits of wearing a new commercially available microcurrent device combined with different exercise training modalities on exercise outcomes, body composition, recovery including muscle damage, general markers of health and immune function in athletes.

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 Jan 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

Study Start

First participant enrolled

January 2, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

March 18, 2018

Last Update Submit

April 16, 2019

Conditions

Training Group, Sensitivity

Keywords

MicrocurrentExercise trainingHypertrophyMuscle damageRecoveryPerformance

Outcome Measures

Primary Outcomes (8)

  • Body composition

    Fat mass

    10 weeks

  • Body composition

    Fat Free Mass

    10 weeks

  • Endurance Performance

    Vo2 max

    10 weeks

  • Strength Performance

    Maximal strength

    10 weeks

  • Blood Markers

    haemoglobin

    10 weeks

  • Blood Markers

    haematocrit

    10 weeks

  • Salivary markers

    Cortisol

    10 weeks

  • Salivary Markers

    HNP1-3

    10 weeks

Secondary Outcomes (4)

  • Hypertrophy

    10 weeks

  • Muscle Damage

    10 weeks

  • Muscle Damage

    10 weeks

  • Muscle Damage

    10 weeks

Study Arms (4)

Resistance Training Microcurrent

EXPERIMENTAL

Participants will combine a 10-week periodized and controlled resistance programme with 3 h of microcurrent after training. Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness

Device: Microcurrent

Resistance Training Shadow

SHAM COMPARATOR

Participants will combine a 10-week periodized and controlled resistance programme with 3 h of sham comparator after training. Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness

Device: Microcurrent

Endurance Training Microcurrent

EXPERIMENTAL

Participants will combine a 10-week periodized and controlled endurance programme with 3 h of microcurrent after training. Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness

Device: Microcurrent

Endurance Training Shadow

SHAM COMPARATOR

Participants will combine a 10-week periodized and controlled endurance programme with 3 h of microcurrent after training. Measurements pre and post-intervention will be body composition via DEXA, endurance performance (1 RM bench press and Squat) endurance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes, IL6, IL1, Myoglobin, salivary cortisol and testosterone. Elbow flexors, vastus medialis and vbastus lateralis muscle thickness

Device: Microcurrent

Interventions

MicrocurrentDEVICE

Microcurrent based treatments have been proposed more than 30 years. The manufacturer initially should calibrate the microcurrent devices. There is no physical sensation associated with microcurrent based treatments as the strength of the current is not high enough to stimulate sensory nerve fibres. The application of electric fields and currents similar to those generated within the body can substantially change the cell structure and the metabolic behaviour of cells. For example, the application of microcurrent increases the number of organelles responsible for cellular activities; it increases concentrations of adenosine triphosphate (ATP) and amino acid transport; promotes protein synthesis; fastens regrowth of atrophied soleus muscle and would also activate hormone-sensitive lipase which can increase lipolysis from the internal and external adipose tissue. The microcurrent treatment with training would maximize exercise and recovery outcomes in athletes.

Endurance Training MicrocurrentEndurance Training ShadowResistance Training MicrocurrentResistance Training Shadow

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Regularly trained endurance or strength athletes
  • Minimum of 6 months of experience

You may not qualify if:

  • Musculoskeletal injuries, metabolic diseases
  • Use of medications
  • Smoking
  • Consuming any nutritional supplements that potentially affect physical performance (e.g., creatine, whey protein, and amino acids) within 6 weeks prior to the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Life and Sports Science

Eltham, London, SE9 2BT, United Kingdom

Location

MeSH Terms

Conditions

HypersensitivityHypertrophy

Condition Hierarchy (Ancestors)

Immune System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Fernando Naclerio, Ph D

    University of Greenwich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind (Subject, Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind randomise controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 26, 2018

Study Start

January 2, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

GB(1)