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Capacitive-resistive Electric Transfer Therapy for Recovery From Running Fatigue (UPV/EHU)

Primary Purpose

Running, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Capacitive-resistive electric transfer (Tecar) therapy
Sponsored by
University of the Basque Country (UPV/EHU)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Running focused on measuring Capacitive-resistive electric transfer therapy, Radiofrequency therapy, Recovery intervention, Fatigue, Running

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Suffered from any injury within the preceding 4 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Tecar treatment group

    Control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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).
    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).
    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).
    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).
    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).
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Body height (cm)
    Body height will be measured using a stadiometer (Año Sayol, Barcelona, Spain) following the guidelines outlined by the International Society for the Advancement of Kinanthropometry.
    Body weight (kg)
    Body weight will be measured using a balance (Año Sayol, Barcelona, Spain) following the guidelines outlined by the International Society for the Advancement of Kinanthropometry.

    Full Information

    First Posted
    October 10, 2017
    Last Updated
    October 17, 2017
    Sponsor
    University of the Basque Country (UPV/EHU)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03317041
    Brief Title
    Capacitive-resistive Electric Transfer Therapy for Recovery From Running Fatigue
    Acronym
    UPV/EHU
    Official Title
    Effects of a Capacitive-resistive Electric Transfer Therapy Exposure on Physiological and Biomechanical Parameters in Recreational Runners: a Randomized Controlled Crossover Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2016 (Actual)
    Primary Completion Date
    July 31, 2016 (Actual)
    Study Completion Date
    September 28, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of the Basque Country (UPV/EHU)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    In this randomized controlled crossover trial all subjects will perform two test protocols separated by 2 weeks. Each protocol will comprise one exhausting training session (20-min warm-up consisted of 15-min of continuous self-paced running followed by 5-min of fast-finish progression runs increasing speeds (from approximately 60% to 80% of maximal heart rate, participant controlled), 10 x 500 m sprints at 90% of maximal heart rate with a 2-min rest period between bouts and a recovery phase consisting of 10-min of slow jogging). Twenty-four hours after this exhausting training, subjects will perform an incremental running test on a treadmill (Pre-intervention test) where subjects will start at 10 km/h for 6 min after which speed will be increased by 2 km/h every 6 min until a 16 km/h trial is completed. One hour after this test, in one protocol subjects will receive Tecar therapy (Tecar treatment group); in the other group (Control group) participants will rest passively in a sitting position for 30-min period. To evaluate the relevance of the changes induced by Tecar therapy/passive recovery, subjects will repeat the treadmill test 48 hours after the first test in both groups (72 hours after the exhaustive training).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Running, Fatigue
    Keywords
    Capacitive-resistive electric transfer therapy, Radiofrequency therapy, Recovery intervention, Fatigue, Running

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tecar treatment group
    Arm Type
    Experimental
    Arm Description
    The capacitive-resistive electric transfer (Tecar) therapy treatment group will receive 45 minutes of Tecar therapy treatment.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Participants will test passively in a sitting position for 30-min period
    Intervention Type
    Other
    Intervention Name(s)
    Capacitive-resistive electric transfer (Tecar) therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    CHANGE FROM BASELINE OXYGEN UPTAKE AT 48 HOURS AFTER THE TREATMENT.
    Description
    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).
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE RESPIRATORY EXCHANGE RATIO AT 48 HOURS AFTER THE TREATMENT.
    Description
    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).
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE VENTILATION AT 48 HOURS AFTER THE TREATMENT.
    Description
    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).
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE HEART RATE AT 48 HOURS AFTER THE TREATMENT.
    Description
    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).
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE BLOOD LACTATE CONCENTRATION AT 48 HOURS AFTER THE TREATMENT.
    Description
    - 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).
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE STRIDE LENGTH AT 48 HOURS AFTER THE TREATMENT.
    Description
    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.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE STRIDE FREQUENCY AT 48 HOURS AFTER THE TREATMENT.
    Description
    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.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE STRIDE ANGLE AT 48 HOURS AFTER THE TREATMENT.
    Description
    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.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE GROUND CONTACT TIME AT 48 HOURS AFTER THE TREATMENT.
    Description
    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.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE SWING TIME AT 48 HOURS AFTER THE TREATMENT.
    Description
    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.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE CONTACT PHASE AT 48 HOURS AFTER THE TREATMENT.
    Description
    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.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE SUPPORT PHASE AT 48 HOURS AFTER THE TREATMENT.
    Description
    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.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Title
    CHANGE FROM BASELINE PUSH-OFF PHASE AT 48 HOURS AFTER THE TREATMENT.
    Description
    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.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session) and at 48 hours after the treatment.
    Secondary Outcome Measure Information:
    Title
    Body height (cm)
    Description
    Body height will be measured using a stadiometer (Año Sayol, Barcelona, Spain) following the guidelines outlined by the International Society for the Advancement of Kinanthropometry.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session).
    Title
    Body weight (kg)
    Description
    Body weight will be measured using a balance (Año Sayol, Barcelona, Spain) following the guidelines outlined by the International Society for the Advancement of Kinanthropometry.
    Time Frame
    Participants will be assessed at baseline (24 hours after an exhaustive training session).

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Recreationally active (current participation in races and a 10-km race time <34.5-min) Exclusion Criteria: Suffered from any injury within the preceding 4 months.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Capacitive-resistive Electric Transfer Therapy for Recovery From Running Fatigue

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