Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

NCT04336007 | Unknown DMC

• 1 other identifier: 20/135-E_TFM
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Athletic Performance

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Age

  through study completion, an average of 4 months

• Sex

  through study completion, an average of 4 months

• International Paralympic Committee Classification.

  through study completion, an average of 4 months

• Weight.

  through study completion, an average of 4 months

• Height.

  through study completion, an average of 4 months

Study Arms (3)

Radio-frequency group

EXPERIMENTAL

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

Device: Resistive Diathermy (INDIBA® Activ Ct9)

Placebo group

PLACEBO COMPARATOR

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

Device: Resistive Diathermy OFF (INDIBA® Activ Ct9)

Control Group

SHAM COMPARATOR

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

Other: Control

Interventions

Resistive Diathermy (INDIBA® Activ Ct9) 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.

Radio-frequency group

Resistive Diathermy OFF (INDIBA® Activ Ct9) 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.

Placebo group

Control OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 36361500 DERIVED

Study Officials

• Pablo Garcia Fernández

  Universidad Complutense de Madrid

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 7, 2020
• Study Start: March 16, 2020
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 11, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)