Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

February 8, 2021 updated by: Universidad Complutense de Madrid
This study aims to evaluate the potential benefits of Monopolar Capacitive Resistive Radio-frequency (448 kHz) on the sports performance of Paralympic swimmers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A randomized, double-blind, crossover, controlled and sham-controlled clinical trial

Evaluate the effectiveness of resistive capacitive diathermy as sports performance enhancement of Paralympic elite swimmers compared with a "sham" diathermy treatment and with a control group. The resistive capacitive diathermy is a medical device supplying low (448 kHz) radiofrequency with a maximum output power of 200 W, used to improve physiological aspects and theoretically allowing improvement in swimming performance. The sham diathermy treatment is administered with the device set on "on" but not active (not supplying energy) and control group will not receive anything, randomly assigned to either resistive capacitive diathermy treatment (group 1), sham-treatment (group 2) or control (group 3) athletes are submitted to a twenty minutes session prior swimming performance. The main outcome measures are the simulate swimming time trial (seconds) to assess time completing the presented course and Borg Scale for perceived exertion. Outcome measures are administered at completing each time trial.

Study Type

Interventional

Enrollment (Anticipated)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Universidad Complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent signed.
  • Age between 18 y 70 years old.
  • Already in the position of the International Paralympic Committee (IPC) classification.
  • Know their personal mark (50-100mts).
  • Having the capacity to fill and understand questionnaires, understand and follow verbal orders.

Exclusion Criteria:

  • Pregnancy.
  • Use of pacemakers or other types of electronic implants
  • Non-intact skin (open wounds or recent burns)
  • thrombophlebitis
  • Known allergy to nickel and chromium
  • Symptomatic anemia (hemoglobin below 12g / dl presenting any of these symptoms: tiredness, shortness of breath, dizziness, palpitations or headache).
  • Present feverish process

Elimination criteria:

  • Revocation of inform consent.
  • Attend to less than three visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radio-frequency group
The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode on.
Device: Resistive Diathermy (INDIBA® Activ Ct9)
Intervention is conducted using a 65-mm diameter Resistive (RES) electrode (movable), and a planar electrode was used as a return electrode on the abdomen. The electricity is administered in the following manner: cream was applied to the upper limbs existent area, and the electrical output is marked at 75% by moving the movable electrode and if not tolerated by the patient lowered until 35%, Therapy is conducted for 20 minutes, prior swimming time trials.
Placebo Comparator: Placebo group
The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode off.
Device: Resistive Diathermy OFF (INDIBA® Activ Ct9)
Placebo is conducted using a 65-mm diameter RES electrode (movable), and a planar electrode was used as a return electrode on the abdomen. The electricity IS NOT administered, the cream was applied to the upper limbs existent area and moving the movable electrode, intervention is conducted for 20 minutes, prior to swimming time trials.
Sham Comparator: Control Group
NO INTERVENTION athlete's usual pre-competition warming-up
Other: Control
This group will warm-up as they usually do in competitions, for later time trial measuring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-trials (Experimental Group)
Time Frame: through study completion, an average of 4 months
Time in Seconds that takes the athlete since taking off from the edge of the pool until reaching two different distances, 50 and 100 meters, measuring each distance twice, time will be measure by technical digital chronometer.
through study completion, an average of 4 months
Time-trials (Placebo Group)
Time Frame: through study completion, an average of 4 months
Time in Seconds that takes the athlete since taking off from the edge of the pool until reaching two different distances, 50 and 100 meters, measuring each distance twice, time will be measure by technical digital chronometer.
through study completion, an average of 4 months
Time-trials (Sham Group)
Time Frame: through study completion, an average of 4 months
Time in Seconds that takes the athlete since taking off from the edge of the pool until reaching two different distances, 50 and 100 meters, measuring each distance twice, time will be measure by technical digital chronometer.
through study completion, an average of 4 months
Change of Perceived exertion (Experimental Group)
Time Frame: through study completion, an average of 4 months
To measure the athlete's qualification of their exertion the Borg Rate of Perceived Exertion (RPE) Scale® will be used, previously validated and with the proper license, measures will be taken pre/post-competition.
through study completion, an average of 4 months
Change of Perceived exertion (Placebo group)
Time Frame: through study completion, an average of 4 months
To measure the athlete's qualification of their exertion the Borg Rate of Perceived Exertion (RPE) Scale® will be used, previously validated and with the proper license, measures will be taken pre/post-competition.
through study completion, an average of 4 months
Change of Perceived exertion (Sham group)
Time Frame: through study completion, an average of 4 months
To measure the athlete's qualification of their exertion the Borg Rate of Perceived Exertion (RPE) Scale® will be used, previously validated and with the proper license, measures will be taken pre/post-competition.
through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: through study completion, an average of 4 months
Birth date collected from the questionaire
through study completion, an average of 4 months
Sex
Time Frame: through study completion, an average of 4 months
Man or Woman
through study completion, an average of 4 months
International Paralympic Committee Classification.
Time Frame: through study completion, an average of 4 months
Code between S1-10, S11-13 or S14
through study completion, an average of 4 months
Weight.
Time Frame: through study completion, an average of 4 months
Weight in kilograms
through study completion, an average of 4 months
Height.
Time Frame: through study completion, an average of 4 months
Height in centimeters
through study completion, an average of 4 months
Daily training time.
Time Frame: through study completion, an average of 4 months
Time of training comprehended on the following intervals 0-3 hours/3-6 hours/>6hours
through study completion, an average of 4 months
Comorbidity
Time Frame: through study completion, an average of 4 months
Presence of different conditions that might interfere with the study.
through study completion, an average of 4 months
Best swimming stroke
Time Frame: through study completion, an average of 4 months
Choose between breaststroke, butterfly stroke, front crawl or backstroke.
through study completion, an average of 4 months
Personal mark 50 mts.
Time Frame: through study completion, an average of 4 months
Best time record for 50 meters distance
through study completion, an average of 4 months
Personal mark 100 mts.
Time Frame: through study completion, an average of 4 months
Best time record for 100 meters distance
through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Study Chair: Pablo Garcia Fernández, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/135-E_TFM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Athletic Performance

Clinical Trials on Resistive Diathermy (INDIBA® Activ Ct9)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe