- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03317041
Capacitive-resistive Electric Transfer Therapy for Recovery From Running Fatigue (UPV/EHU)
Effects of a Capacitive-resistive Electric Transfer Therapy Exposure on Physiological and Biomechanical Parameters in Recreational Runners: a Randomized Controlled Crossover Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tecar treatment group
The capacitive-resistive electric transfer (Tecar) therapy treatment group will receive 45 minutes of Tecar therapy treatment.
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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.
|
|
No Intervention: Control group
Participants will test passively in a sitting position for 30-min period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CHANGE FROM BASELINE OXYGEN UPTAKE AT 48 HOURS AFTER THE TREATMENT.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
|
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CHANGE FROM BASELINE HEART RATE AT 48 HOURS AFTER THE TREATMENT.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
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|
CHANGE FROM BASELINE STRIDE LENGTH AT 48 HOURS AFTER THE TREATMENT.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
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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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
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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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
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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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
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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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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.
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session) and 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body height (cm)
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session).
|
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.
|
Participants will be assessed at baseline (24 hours after an exhaustive training session).
|
|
Body weight (kg)
Time Frame: Participants will be assessed at baseline (24 hours after an exhaustive training session).
|
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.
|
Participants will be assessed at baseline (24 hours after an exhaustive training session).
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 313-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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