Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

Athletic Performance Clinical Trial

Official title:

Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04336007
• Other study ID #: 20/135-E_TFM
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 16, 2020
• Est. completion date: July 2021

Study information

• Verified date: March 2020
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 13
• Est. completion date: July 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Athletic Performance

Intervention

Device:
• 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.
• 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.

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

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Age	Birth date collected from the questionaire	through study completion, an average of 4 months
Secondary	Sex	Man or Woman	through study completion, an average of 4 months
Secondary	International Paralympic Committee Classification.	Code between S1-10, S11-13 or S14	through study completion, an average of 4 months
Secondary	Weight.	Weight in kilograms	through study completion, an average of 4 months
Secondary	Height.	Height in centimeters	through study completion, an average of 4 months
Secondary	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
Secondary	Comorbidity	Presence of different conditions that might interfere with the study.	through study completion, an average of 4 months
Secondary	Best swimming stroke	Choose between breaststroke, butterfly stroke, front crawl or backstroke.	through study completion, an average of 4 months
Secondary	Personal mark 50 mts.	Best time record for 50 meters distance	through study completion, an average of 4 months
Secondary	Personal mark 100 mts.	Best time record for 100 meters distance	through study completion, an average of 4 months