NCT04939181

Brief Summary

Competitive team sports calendars are becoming increasingly compressed, generating changes in the effort-recovery cycle. Given this new situation, it seems necessary to analyze how it affects the physiological and performance level of semi-professional players, as well as how to observe if the non-invasive neuromodulation technique NESA helps the neuroefficiency and concentration values of said players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2021

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

June 8, 2021

Last Update Submit

December 10, 2021

Conditions

Basketball Player

Keywords

physical therapy modalityElectric Stimulation Therapybasketball

Outcome Measures

Primary Outcomes (1)

  • Changes in creatinine kinase level

    For the analysis of these biomarkers, a saliva sample, collected with Salivette containers will be necessary. Once the sample is obtained, it will be kept following the necessary security protocols and sent to a laboratory for further analysis.

    48 hours before the first match, immediately after the match and 48 hours after the match

Secondary Outcomes (7)

  • Kinematic demand parameters (external load) I

    Through study completion, an average of 6 weeks

  • Kinematic demand parameters (external load) II

    During the match and all the intervention ( 6 weeks)

  • Kinematic demand parameters (external load) III

    During all the intervention ( 6 weeks)

  • Kinematic demand parameters (external load) IV

    Through study completion, an average of 6 weeks

  • Cardiovascular parameters: heart rate variability (VHR)

    Up to 6 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Basketball free throw efficiency

    Up to 6 weeks

Study Arms (2)

Non-invasive Neuromodulation

EXPERIMENTAL

Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Device: Non-invasive Neuromodulation

Placebo Non-invasive Neuromodulation

PLACEBO COMPARATOR

Placebo microcurrents Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Device: Placebo Non-invasive Neuromodulation

Interventions

Non-invasive NeuromodulationDEVICE

The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA.

Non-invasive Neuromodulation
Placebo Non-invasive NeuromodulationDEVICE

The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.

Placebo Non-invasive Neuromodulation

Eligibility Criteria

Age18 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsA men's basketball team will be evaluated
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Belonging to the team
  • Participants do not present injury or pathology during the study
  • In normal conditions and mentally competent to participate in the study.
  • In condition to complete the study questionnaires.

You may not qualify if:

  • Present some of the contraindications for a treatment with non-invasive neuromodulation: pacemakers, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
  • Not having signed the informed consent.
  • Present any injury or pathology during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aníbal Báez-Suárez

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

Location

Related Publications (11)

  • Impellizzeri FM, Marcora SM, Coutts AJ. Internal and External Training Load: 15 Years On. Int J Sports Physiol Perform. 2019 Feb 1;14(2):270-273. doi: 10.1123/ijspp.2018-0935. Epub 2019 Jan 6.

    PMID: 30614348RESULT

  • Vanrenterghem J, Nedergaard NJ, Robinson MA, Drust B. Training Load Monitoring in Team Sports: A Novel Framework Separating Physiological and Biomechanical Load-Adaptation Pathways. Sports Med. 2017 Nov;47(11):2135-2142. doi: 10.1007/s40279-017-0714-2.

    PMID: 28283992RESULT

  • Kellmann M, Bertollo M, Bosquet L, Brink M, Coutts AJ, Duffield R, Erlacher D, Halson SL, Hecksteden A, Heidari J, Kallus KW, Meeusen R, Mujika I, Robazza C, Skorski S, Venter R, Beckmann J. Recovery and Performance in Sport: Consensus Statement. Int J Sports Physiol Perform. 2018 Feb 1;13(2):240-245. doi: 10.1123/ijspp.2017-0759. Epub 2018 Feb 19.

    PMID: 29345524RESULT

  • Bragazzi NL, Khoramipour K, Chaouachi A, Chamari K. Toward Sportomics: Shifting From Sport Genomics to Sport Postgenomics and Metabolomics Specialties. Promises, Challenges, and Future Perspectives. Int J Sports Physiol Perform. 2020 Sep 22;15(9):1201-1202. doi: 10.1123/ijspp.2020-0648. No abstract available.

    PMID: 32963119RESULT

  • Fernandez D, Varo F, Carmona G, Reche X. Quantification of external load of elite rink hockey players in official matches. J Sports Med Phys Fitness. 2020 Dec;60(12):1520-1525. doi: 10.23736/S0022-4707.20.11097-1. Epub 2020 Jun 30.

    PMID: 32608935RESULT

  • Torreno N, Munguia-Izquierdo D, Coutts A, de Villarreal ES, Asian-Clemente J, Suarez-Arrones L. Relationship Between External and Internal Loads of Professional Soccer Players During Full Matches in Official Games Using Global Positioning Systems and Heart-Rate Technology. Int J Sports Physiol Perform. 2016 Oct;11(7):940-946. doi: 10.1123/ijspp.2015-0252. Epub 2016 Aug 24.

    PMID: 26816391RESULT

  • Rabbani A, Clemente FM, Kargarfard M, Chamari K. Match Fatigue Time-Course Assessment Over Four Days: Usefulness of the Hooper Index and Heart Rate Variability in Professional Soccer Players. Front Physiol. 2019 Feb 19;10:109. doi: 10.3389/fphys.2019.00109. eCollection 2019.

    PMID: 30837890RESULT

  • Dong JG. The role of heart rate variability in sports physiology. Exp Ther Med. 2016 May;11(5):1531-1536. doi: 10.3892/etm.2016.3104. Epub 2016 Feb 23.

    PMID: 27168768RESULT

  • Rave G, Zouhal H, Boullosa D, Doyle-Baker PK, Saeidi A, Abderrahman AB, Fortrat JO. Heart Rate Variability is Correlated with Perceived Physical Fitness in Elite Soccer Players. J Hum Kinet. 2020 Mar 31;72:141-150. doi: 10.2478/hukin-2019-0103. eCollection 2020 Mar.

    PMID: 32269655RESULT

  • Castro-Sepulveda M, Cancino J, Fernandez-Verdejo R, Perez-Luco C, Jannas-Vela S, Ramirez-Campillo R, Del Coso J, Zbinden-Foncea H. Basal Serum Cortisol and Testosterone/Cortisol Ratio Are Related to Rate of Na+ Lost During Exercise in Elite Soccer Players. Int J Sport Nutr Exerc Metab. 2019 Nov 1;29(6):658-663. doi: 10.1123/ijsnem.2019-0129.

    PMID: 31629352RESULT

  • Garcia F, Fernandez D, Vazquez-Guerrero J, Font R, Moreno-Planas B, Alamo-Arce D, Medina-Ramirez R, Mallol-Soler M. Recovery of the physiological status in professional basketball players using NESA neuromodulation treatment during different types of microcycles in season: A preliminary randomized clinical trial. Front Physiol. 2022 Nov 22;13:1032020. doi: 10.3389/fphys.2022.1032020. eCollection 2022.

    PMID: 36483295DERIVED

Study Officials

  • Aníbal Báez-Suárez, PhD

    University of Las Palmas de Gran Canaria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 25, 2021

Study Start

May 1, 2021

Primary Completion

September 30, 2021

Study Completion

November 18, 2021

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)