Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers
Primary Purpose
Athletic Performance
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Resistive Diathermy (INDIBA® Activ Ct9)
Resistive Diathermy OFF (INDIBA® Activ Ct9)
Control
Sponsored by
About this trial
This is an interventional other trial for Athletic Performance
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.
Sites / Locations
- Universidad Complutense de Madrid
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Sham Comparator
Arm Label
Radio-frequency group
Placebo group
Control Group
Arm Description
The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode on.
The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode off.
NO INTERVENTION athlete's usual pre-competition warming-up
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Age
Birth date collected from the questionaire
Sex
Man or Woman
International Paralympic Committee Classification.
Code between S1-10, S11-13 or S14
Weight.
Weight in kilograms
Height.
Height in centimeters
Daily training time.
Time of training comprehended on the following intervals 0-3 hours/3-6 hours/>6hours
Comorbidity
Presence of different conditions that might interfere with the study.
Best swimming stroke
Choose between breaststroke, butterfly stroke, front crawl or backstroke.
Personal mark 50 mts.
Best time record for 50 meters distance
Personal mark 100 mts.
Best time record for 100 meters distance
Full Information
NCT ID
NCT04336007
First Posted
March 24, 2020
Last Updated
February 8, 2021
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04336007
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Athletic Performance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radio-frequency group
Arm Type
Experimental
Arm Description
The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode on.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode off.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
NO INTERVENTION athlete's usual pre-competition warming-up
Intervention Type
Device
Intervention Name(s)
Resistive Diathermy (INDIBA® Activ Ct9)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Resistive Diathermy OFF (INDIBA® Activ Ct9)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
This group will warm-up as they usually do in competitions, for later time trial measuring.
Primary Outcome Measure Information:
Title
Time-trials (Experimental Group)
Description
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 Frame
through study completion, an average of 4 months
Title
Time-trials (Placebo Group)
Description
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 Frame
through study completion, an average of 4 months
Title
Time-trials (Sham Group)
Description
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 Frame
through study completion, an average of 4 months
Title
Change of Perceived exertion (Experimental Group)
Description
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 Frame
through study completion, an average of 4 months
Title
Change of Perceived exertion (Placebo group)
Description
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 Frame
through study completion, an average of 4 months
Title
Change of Perceived exertion (Sham group)
Description
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 Frame
through study completion, an average of 4 months
Secondary Outcome Measure Information:
Title
Age
Description
Birth date collected from the questionaire
Time Frame
through study completion, an average of 4 months
Title
Sex
Description
Man or Woman
Time Frame
through study completion, an average of 4 months
Title
International Paralympic Committee Classification.
Description
Code between S1-10, S11-13 or S14
Time Frame
through study completion, an average of 4 months
Title
Weight.
Description
Weight in kilograms
Time Frame
through study completion, an average of 4 months
Title
Height.
Description
Height in centimeters
Time Frame
through study completion, an average of 4 months
Title
Daily training time.
Description
Time of training comprehended on the following intervals 0-3 hours/3-6 hours/>6hours
Time Frame
through study completion, an average of 4 months
Title
Comorbidity
Description
Presence of different conditions that might interfere with the study.
Time Frame
through study completion, an average of 4 months
Title
Best swimming stroke
Description
Choose between breaststroke, butterfly stroke, front crawl or backstroke.
Time Frame
through study completion, an average of 4 months
Title
Personal mark 50 mts.
Description
Best time record for 50 meters distance
Time Frame
through study completion, an average of 4 months
Title
Personal mark 100 mts.
Description
Best time record for 100 meters distance
Time Frame
through study completion, an average of 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Garcia Fernández
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Chair
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36361500
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.
Results Reference
derived
Learn more about this trial
Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers
We'll reach out to this number within 24 hrs