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Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04336007
Enrollment
13
Registered
2020-04-07
Start date
2020-03-16
Completion date
2021-07-31
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Athletic Performance

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.

Interventions

DEVICEResistive 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.

DEVICEResistive 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.

OTHERControl

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

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Time-trials (Experimental Group)through study completion, an average of 4 monthsTime 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.
Time-trials (Placebo Group)through study completion, an average of 4 monthsTime 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.
Time-trials (Sham Group)through study completion, an average of 4 monthsTime 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.
Change of Perceived exertion (Experimental Group)through study completion, an average of 4 monthsTo 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.
Change of Perceived exertion (Placebo group)through study completion, an average of 4 monthsTo 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.
Change of Perceived exertion (Sham group)through study completion, an average of 4 monthsTo 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.

Secondary

MeasureTime frameDescription
Comorbiditythrough study completion, an average of 4 monthsPresence of different conditions that might interfere with the study.
Best swimming strokethrough study completion, an average of 4 monthsChoose between breaststroke, butterfly stroke, front crawl or backstroke.
Agethrough study completion, an average of 4 monthsBirth date collected from the questionaire
Personal mark 100 mts.through study completion, an average of 4 monthsBest time record for 100 meters distance
Personal mark 50 mts.through study completion, an average of 4 monthsBest time record for 50 meters distance
Sexthrough study completion, an average of 4 monthsMan or Woman
International Paralympic Committee Classification.through study completion, an average of 4 monthsCode between S1-10, S11-13 or S14
Weight.through study completion, an average of 4 monthsWeight in kilograms
Height.through study completion, an average of 4 monthsHeight in centimeters
Daily training time.through study completion, an average of 4 monthsTime of training comprehended on the following intervals 0-3 hours/3-6 hours/\>6hours

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026