Athletic PerformanceNCT04336007
Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers
A study testing Resistive Diathermy (INDIBA® Activ Ct9) and Resistive Diathermy OFF (INDIBA® Activ Ct9) in people with Athletic Performance, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Resistive Diathermy (INDIBA® Activ Ct9) and Resistive Diathermy OFF (INDIBA® Activ Ct9)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- 16 Mar 2020to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- Present feverish process
- Elimination criteria:
- Revocation of inform consent.
- Attend to less than three visits.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the potential benefits of Monopolar Capacitive Resistive Radio-frequency (448 kHz) on the sports performance of Paralympic swimmers.
Read the 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.
- Conditions
- Athletic Performance
- Being tested
- Resistive Diathermy (INDIBA® Activ Ct9), Resistive Diathermy OFF (INDIBA® Activ Ct9), Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistive Diathermy (INDIBA® Activ Ct9)Device
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)Device
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.
ControlOther
This group will warm-up as they usually do in competitions, for later time trial measuring.
| Study group | Role | What they receive |
|---|---|---|
| Radio-frequency group | Experimental | The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode on. Receives: Device: Resistive Diathermy (INDIBA® Activ Ct9) |
| Placebo group | Placebo comparator | The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode off. Receives: Device: Resistive Diathermy OFF (INDIBA® Activ Ct9) |
| Control Group | Sham comparator | NO INTERVENTION athlete's usual pre-competition warming-up Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 4 months
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.
Measured: through study completion, an average of 4 months
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.
Measured: through study completion, an average of 4 months
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.
Measured: through study completion, an average of 4 months
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.
Measured: through study completion, an average of 4 months
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.
Measured: through study completion, an average of 4 months
Secondary outcomes (10)
Age
Birth date collected from the questionaire
Measured: through study completion, an average of 4 months
Sex
Man or Woman
Measured: through study completion, an average of 4 months
International Paralympic Committee Classification.
Code between S1-10, S11-13 or S14
Measured: through study completion, an average of 4 months
Weight.
Weight in kilograms
Measured: through study completion, an average of 4 months
Height.
Height in centimeters
Measured: through study completion, an average of 4 months
Daily training time.
Time of training comprehended on the following intervals 0-3 hours/3-6 hours/>6hours
Measured: through study completion, an average of 4 months
Comorbidity
Presence of different conditions that might interfere with the study.
Measured: through study completion, an average of 4 months
Best swimming stroke
Choose between breaststroke, butterfly stroke, front crawl or backstroke.
Measured: through study completion, an average of 4 months
Personal mark 50 mts.
Best time record for 50 meters distance
Measured: through study completion, an average of 4 months
Personal mark 100 mts.
Best time record for 100 meters distance
Measured: through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start16 Mar 2020
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Athletic PerformanceStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Garcia Fernández, Study chair, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336007
- Sponsor's protocol ID
- 20/135-E_TFM
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36361500
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diathermy Application on Immediate Sports Performance of Paralympic Swimmers
- ClinicalTrials.gov ID
- NCT04336007
- Acronym / sponsor ID
- 20/135-E_TFM
- Conditions
- Athletic Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radio-frequency group | Experimental | Device: Resistive Diathermy (INDIBA® Activ Ct9)The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode on. |
| Placebo group | Placebo comparator | Device: Resistive Diathermy OFF (INDIBA® Activ Ct9)The equipment used, INDIBA® Activ Ct9, (448kHz), with the switch-mode off. |
| Control Group | Sham comparator | Other: ControlNO INTERVENTION athlete's usual pre-competition warming-up |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Radio-frequency group |
| 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. | Device | Placebo group |
| ControlThis group will warm-up as they usually do in competitions, for later time trial measuring. | Other | Control Group |
Primary outcome
Time-trials (Experimental Group)
Time frame: 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 (Placebo Group)
Time frame: 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)
Time frame: 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 (Experimental Group)
Time frame: 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 (Placebo group)
Time frame: 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)
Time frame: 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.
10 secondary outcomes
Age
Time frame: through study completion, an average of 4 months
Sex
Time frame: through study completion, an average of 4 months
International Paralympic Committee Classification.
Time frame: through study completion, an average of 4 months
Weight.
Time frame: through study completion, an average of 4 months
Height.
Time frame: through study completion, an average of 4 months
Daily training time.
Time frame: through study completion, an average of 4 months
Comorbidity
Time frame: through study completion, an average of 4 months
Best swimming stroke
Time frame: through study completion, an average of 4 months
Personal mark 50 mts.
Time frame: through study completion, an average of 4 months
Personal mark 100 mts.
Time frame: through study completion, an average of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 36361500De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Garcia Fernández study chair
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistive Diathermy (INDIBA® Activ Ct9) and Resistive Diathermy OFF (INDIBA® Activ Ct9) in people with Athletic Performance, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-trials (Experimental Group) (time frame: through study completion, an average of 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.