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Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

Not Applicable
Conditions
Athletic Performance
Interventions
Device: Resistive Diathermy OFF (INDIBA® Activ Ct9)
Other: Control
Device: Resistive Diathermy (INDIBA® Activ Ct9)
Registration Number
NCT04336007
Lead Sponsor
Universidad Complutense de Madrid
Brief Summary

This study aims to evaluate the potential benefits of Monopolar Capacitive Resistive Radio-frequency (448 kHz) on the sports performance of Paralympic swimmers.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
13
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Placebo groupResistive Diathermy OFF (INDIBA® Activ Ct9)The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode off.
Control GroupControlNO INTERVENTION athlete's usual pre-competition warming-up
Radio-frequency groupResistive Diathermy (INDIBA® Activ Ct9)The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode on.
Primary Outcome Measures
NameTimeMethod
Time-trials (Experimental Group)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.

Change of Perceived exertion (Placebo group)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.

Change of Perceived exertion (Experimental Group)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.

Change of Perceived exertion (Sham group)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.

Time-trials (Placebo Group)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.

Time-trials (Sham Group)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.

Secondary Outcome Measures
NameTimeMethod
Personal mark 50 mts.through study completion, an average of 4 months

Best time record for 50 meters distance

Sexthrough study completion, an average of 4 months

Man or Woman

International Paralympic Committee Classification.through study completion, an average of 4 months

Code between S1-10, S11-13 or S14

Weight.through study completion, an average of 4 months

Weight in kilograms

Height.through study completion, an average of 4 months

Height in centimeters

Daily training time.through study completion, an average of 4 months

Time of training comprehended on the following intervals 0-3 hours/3-6 hours/\>6hours

Personal mark 100 mts.through study completion, an average of 4 months

Best time record for 100 meters distance

Agethrough study completion, an average of 4 months

Birth date collected from the questionaire

Comorbiditythrough study completion, an average of 4 months

Presence of different conditions that might interfere with the study.

Best swimming strokethrough study completion, an average of 4 months

Choose between breaststroke, butterfly stroke, front crawl or backstroke.

Trial Locations

Locations (1)

Universidad Complutense de Madrid

🇪🇸

Madrid, Spain

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