Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

NCT ID: NCT04336007

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-16
• Study Completion Date: 2021-07-31

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.

Conditions

Athletic Performance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Radio-frequency group

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

Group Type: EXPERIMENTAL

Resistive Diathermy (INDIBA® Activ Ct9)

Intervention Type: DEVICE

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 group

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

Group Type: PLACEBO_COMPARATOR

Resistive Diathermy OFF (INDIBA® Activ Ct9)

Intervention Type: DEVICE

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.

Control Group

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

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

This group will warm-up as they usually do in competitions, for later time trial measuring.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Control

This group will warm-up as they usually do in competitions, for later time trial measuring.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo Garcia Fernández

Role: STUDY_CHAIR

Universidad Complutense de Madrid

Locations

Universidad Complutense de Madrid

Madrid, , Spain

Countries

Spain

References

De Sousa-De Sousa L, Espinosa HG, Mate-Munoz JL, Lozano-Estevan MDC, Cerrolaza-Tudanca S, Rozalen-Bustin M, Fernandez-Carnero S, Garcia-Fernandez P. Effects of Capacitive-Resistive Electric Transfer on Sports Performance in Paralympic Swimmers: A Stopped Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Nov 7;19(21):14620. doi: 10.3390/ijerph192114620.

Reference Type: DERIVED

PMID: 36361500 (View on PubMed)

Other Identifiers

20/135-E_TFM

Identifier Type: -

Identifier Source: org_study_id