NCT03317041

Brief Summary

Reducing fatigue and improving the recovery capabilities of runners has gained more interest over the last years. Recently, capacitive-resistive electric transfer (Tecar) therapy is commonly used by physical therapists to help athletes recover from muscle fatigue. However, empiric evidence supporting the benefits of Tecar to recovery is lacking. This study investigated the effects of a Tecar treatment performed shortly after an exhausting training session on both physiological and biomechanical parameters of running.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

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

March 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
Last Updated

October 23, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

October 10, 2017

Last Update Submit

October 17, 2017

Conditions

Keywords

Capacitive-resistive electric transfer therapyRadiofrequency therapyRecovery interventionFatigueRunning

Outcome Measures

Primary Outcomes (13)

  • CHANGE FROM BASELINE OXYGEN UPTAKE AT 48 HOURS AFTER THE TREATMENT.

    Oxygen uptake (mL kg-1 min-1) will be assessed in an incremental running test on a treadmill (HP Cosmos pulsar, Nussdorf-Traunstein, Germany). Oxygen uptake will be recorded using a gas analyzer system (Esgostik Geratherm, Geschwenda, Germany).

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE RESPIRATORY EXCHANGE RATIO AT 48 HOURS AFTER THE TREATMENT.

    Respiratory exchange ratio (ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2)) will be assessed in an incremental running test on a treadmill (HP Cosmos pulsar, Nussdorf-Traunstein, Germany). Respiratory exchange ratio will be recorded using a gas analyzer system (Esgostik Geratherm, Geschwenda, Germany).

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE VENTILATION AT 48 HOURS AFTER THE TREATMENT.

    Ventilation (L• min-1) will be assessed in an incremental running test on a treadmill (HP Cosmos pulsar, Nussdorf-Traunstein, Germany). Ventilatory output will be recorded using a gas analyzer system (Esgostik Geratherm, Geschwenda, Germany).

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE HEART RATE AT 48 HOURS AFTER THE TREATMENT.

    Heart rate (beat • min-1) will be assessed in an incremental running test on a treadmill (HP Cosmos pulsar, Nussdorf-Traunstein, Germany). Heart rate will be recorded by a heart monitor (Polar RS800, Kempele, Finland).

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE BLOOD LACTATE CONCENTRATION AT 48 HOURS AFTER THE TREATMENT.

    \- Blood lactate concentration (mmol •L-1) will be assessed in an incremental running test on a treadmill (HP Cosmos pulsar, Nussdorf-Traunstein, Germany). Capillary blood samples will be obtained in each test from the earlobe for the determination of blood lactate concentration by a portable lactate analyzer (Lactate, Arkray, KDK Corporation, Kyoto, Japan).

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE STRIDE LENGTH AT 48 HOURS AFTER THE TREATMENT.

    Stride length (cm), defined as the length the treadmill belt moves from toe-off to initial ground contact in successive steps, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE STRIDE FREQUENCY AT 48 HOURS AFTER THE TREATMENT.

    Stride frequency, defined as the number of ground contact events per minute, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE STRIDE ANGLE AT 48 HOURS AFTER THE TREATMENT.

    Stride angle (º), defined as the angle of the parable tangent derived from the theoretical arc traced by a foot during a stride and the ground, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE GROUND CONTACT TIME AT 48 HOURS AFTER THE TREATMENT.

    Ground contact time (s), defined as the time from when the foot contacts the ground to when the toes left the ground and was determined by the disruption of the infrared gates, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE SWING TIME AT 48 HOURS AFTER THE TREATMENT.

    The swing time (s) corresponds to the time from foot flat to initial take-off. Swing time will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE CONTACT PHASE AT 48 HOURS AFTER THE TREATMENT.

    Contact phase (%), defined as the percentage of the ground contact time at which the different sub-phases of stance phase occur, will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE SUPPORT PHASE AT 48 HOURS AFTER THE TREATMENT.

    The support sub-phase (%) corresponds to the time from initial ground contact to foot flat. Support phase will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

  • CHANGE FROM BASELINE PUSH-OFF PHASE AT 48 HOURS AFTER THE TREATMENT.

    The push-off phase (%) corresponds to the time from initial take-off to toe-off. Push-off phase will be measured using an optical measurement system (Optojump-next, Microgate, Bolzano, Italy) placed at the treadmill belt level.

    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.

Secondary Outcomes (2)

  • Body height (cm)

    Participants will be assessed at baseline (24 hours after an exhaustive training session).

  • Body weight (kg)

    Participants will be assessed at baseline (24 hours after an exhaustive training session).

Study Arms (2)

Tecar treatment group

EXPERIMENTAL

The capacitive-resistive electric transfer (Tecar) therapy treatment group will receive 45 minutes of Tecar therapy treatment.

Other: Capacitive-resistive electric transfer (Tecar) therapy

Control group

NO INTERVENTION

Participants will test passively in a sitting position for 30-min period

Interventions

The Tecar treatment group will receive 45 minutes of Tecar therapy treatment. Subjects will lay down with the face down and two metallic plaques situated under each quadriceps muscle all over all the treatment. The treatment will start with the automatic capacitive energy transfer for 10-min where the capacitive plaque is situated on the sole of each foot with an elastic band. After that, the capacitive plaque will be pulled out. Then, the resistive electrode will be moved longitudinally through different muscles with massage lotion during 15-min per each lower extremity. The treatment will conclude with the automatic capacitive energy transfer for 10-min and the capacitive plaque situated on the sole of each foot with an elastic band.

Tecar treatment group

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreationally active (current participation in races and a 10-km race time \<34.5-min)

You may not qualify if:

  • Suffered from any injury within the preceding 4 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fatigue

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 10, 2017

First Posted

October 23, 2017

Study Start

March 1, 2016

Primary Completion

July 31, 2016

Study Completion

September 28, 2016

Last Updated

October 23, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share