Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

Universidad Complutense de Madrid

Status: Unknown

Conditions: Athletic Performance

Treatments: Other: Control; Device: Resistive Diathermy OFF (INDIBA® Activ Ct9); Device: Resistive Diathermy (INDIBA® Activ Ct9)

Study type: Interventional

Funder types: Other

Identifiers

NCT04336007

20/135-E_TFM

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 3 patient groups, including a placebo group

Radio-frequency group

Experimental group

Description:

The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode on.

Treatment:

Device: Resistive Diathermy (INDIBA® Activ Ct9)

Placebo group

Placebo Comparator group

Description:

The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode off.

Treatment:

Device: Resistive Diathermy OFF (INDIBA® Activ Ct9)

Control Group

Sham Comparator group

Description:

NO INTERVENTION athlete's usual pre-competition warming-up

Treatment:

Other: Control