Clinical trial NCT04336007: Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers
Official title: Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Athletic Performance
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Time-trials (Experimental Group)
timeFrame: through study completion, an average of 4 months
measure: Time-trials (Placebo Group)
timeFrame: through study completion, an average of 4 months
measure: Time-trials (Sham Group)
timeFrame: through study completion, an average of 4 months
measure: Change of Perceived exertion (Experimental Group)
timeFrame: through study completion, an average of 4 months
measure: Change of Perceived exertion (Placebo group)
timeFrame: through study completion, an average of 4 months
measure: Change of Perceived exertion (Sham group)
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
measure: Age
timeFrame: through study completion, an average of 4 months
measure: Sex
timeFrame: through study completion, an average of 4 months
measure: International Paralympic Committee Classification.
timeFrame: through study completion, an average of 4 months
measure: Weight.
timeFrame: through study completion, an average of 4 months
measure: Height.
timeFrame: through study completion, an average of 4 months
measure: Daily training time.
timeFrame: through study completion, an average of 4 months
measure: Comorbidity
timeFrame: through study completion, an average of 4 months
measure: Best swimming stroke
timeFrame: through study completion, an average of 4 months
measure: Personal mark 50 mts.
timeFrame: through study completion, an average of 4 months
measure: Personal mark 100 mts.
timeFrame: through study completion, an average of 4 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Pablo Garcia Fernández
role: STUDY_CHAIR
References:
citation: 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.