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RunningUPV/EHUNCT03317041

Capacitive-resistive Electric Transfer Therapy for Recovery From Running Fatigue

A study testing Capacitive-resistive electric transfer (Tecar) therapy in people with Running and Fatigue, run by University of the Basque Country (UPV/EHU).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Running, Fatigue
What is being tested?
Capacitive-resistive electric transfer (Tecar) therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
1 Mar 2016to 28 Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Suffered from any injury within the preceding 4 months.

About this study

Official title: Effects of a Capacitive-resistive Electric Transfer Therapy Exposure on Physiological and Biomechanical Parameters in Recreational Runners: a Randomized Controlled Crossover Trial

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.

Read the 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).

Conditions
Running, Fatigue
Being tested
Capacitive-resistive electric transfer (Tecar) therapy
Keywords
Capacitive-resistive electric transfer therapy, Radiofrequency therapy, Recovery intervention, Fatigue, Running
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capacitive-resistive electric transfer (Tecar) therapyOther

    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.

Study groups in NCT03317041
Study groupRoleWhat they receive
Tecar treatment groupExperimentalThe capacitive-resistive electric transfer (Tecar) therapy treatment group will receive 45 minutes of Tecar therapy treatment.
Receives: Other: Capacitive-resistive electric transfer (Tecar) therapy
Control groupNo interventionParticipants will test passively in a sitting position for 30-min period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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).

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

  3. 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).

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

  4. 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).

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

  5. 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).

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

Secondary outcomes (2)
  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study start1 Mar 2016
  3. Primary completion31 Jul 2016
  4. Study completion28 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03317041
Sponsor's protocol ID
313-2015
Acronym
UPV/EHU
Status last verified
Oct 2017
First submitted
10 Oct 2017
Last updated
23 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Capacitive-resistive electric transfer (Tecar) therapy in people with Running and Fatigue, run by University of the Basque Country (UPV/EHU).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2017.

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