Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

Conditions
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Athletic Performance

Intervention / Treatment
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* Device: Resistive Diathermy (INDIBA® Activ Ct9)
* Device: Resistive Diathermy OFF (INDIBA® Activ Ct9)
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radio-frequency group<br>The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode on. | Device: Resistive Diathermy (INDIBA® Activ Ct9)<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode off. | Device: Resistive Diathermy OFF (INDIBA® Activ Ct9)<br>* 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.<br>|
| Sham Comparator: Control Group<br>NO INTERVENTION athlete's usual pre-competition warming-up | Other: Control<br>* This group will warm-up as they usually do in competitions, for later time trial measuring.<br>|

What is the study measuring?
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Primary Outcome Measures

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