跳至主要内容
临床试验/NCT04336007
NCT04336007Unknown不适用

Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers

Universidad Complutense de Madrid2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2020年3月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
13
试验地点
2
主要终点
Time-trials (Experimental Group)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Time-trials (Experimental Group)

时间窗: through study completion, an average of 4 months

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.

Change of Perceived exertion (Placebo group)

时间窗: through study completion, an average of 4 months

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.

Change of Perceived exertion (Experimental Group)

时间窗: through study completion, an average of 4 months

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.

Change of Perceived exertion (Sham group)

时间窗: through study completion, an average of 4 months

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.

Time-trials (Placebo Group)

时间窗: through study completion, an average of 4 months

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.

Time-trials (Sham Group)

时间窗: through study completion, an average of 4 months

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.

次要结局

  • Weight.(through study completion, an average of 4 months)
  • Personal mark 50 mts.(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)
  • Height.(through study completion, an average of 4 months)
  • Daily training time.(through study completion, an average of 4 months)
  • Personal mark 100 mts.(through study completion, an average of 4 months)
  • Age(through study completion, an average of 4 months)
  • Comorbidity(through study completion, an average of 4 months)
  • Best swimming stroke(through study completion, an average of 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验