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Trial registered on ANZCTR

Registration number

ACTRN12623000677606

Ethics application status

Approved

Date submitted

22/03/2023

Date registered

23/06/2023

Date last updated

23/06/2023

Date data sharing statement initially provided

23/06/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of transcranial and peripheral magnetic stimulation on quadriceps strength,muscle activation and pain recovery after and intense eccentric exercise causing delayed onset muscle soreness to young athletes

Scientific title

“Effects of combined treatment with peripheral electromagnetic stimulation and transcranial electromagnetic stimulation on recovery from late-onset muscle damage induced by eccentric exercise in young athletes. A randomized clinical trial”

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

impaired muscle activation

pain

muscle performance

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The subjects will have to undergo a common and generalized warm-up before starting the eccentric exercises. The warm-up is comprised of standing hip and knee mobility along with ballistic stretches for the quadriceps and hamstrings. Then, one set of skipping followed by one set of 10 reps of bodyweight squats and one set of bodyweight lunges. The protocol is based on the study by (Howatson et al., 2012).
Once the warm-up is done, the subjects will have to perform 3 eccentric exercises focused on the quadriceps within which there will be:

- 10 series of 10 repetitions of squats at 60% of the 1 RM. Said load was calculated before the study to facilitate the performance and understanding of the procedure by the subjects. Which series will be performed with the help of a Smith Multipower Bar guide machine so that there are no parasitic movements and focus the work on the quadriceps.
- 3 series of 10 repetitions per leg of the Bulgarian squat. Subjects may add up to 10 kilos depending on how they will feel after squats, this possible change will have to be specified before the start of the exercise.
- 3 series of 10 repetitions per leg of Strides, likewise with possible added load by prior request of the subject depending on how he will be after the first 2 exercises.

The rest times will always be the same, that is, 2 minute rest between series and series. As for the rest between exercises, they will be left 4 minutes so that they have enough strength to finish the entire session. All the exercises and the warm up will be supervised by a strength and condition trainer and a sports physical therapy expert. Afterwards, once they have finished the eccentric protocol they will go to the group they belong to.

-The first group will be treated just after they finished the eccentric exercise circuit,24,48 and 72 hours after the exercises, with transcranial magnetic stimulation (MAGREX)on Motor cortex (2000 pulses at 10 hz, 90% of the motor threshold calculated after finding the motor threshold which is an evoke potencial over 50 microvolts repeated at least 5. out of 10 times) (ARM 1).The treatment will be delivered by an expert physical therapist with more than 10 years of experience in this technique.
-second group will be treated after they finished the eccentric exercise circuit,24,48 and 72 hours after the exercises, with a peripheral magnetic stimulation (MAGREX). 5 stimulations at a sensitive threshold (subject must report that he feels the current) over the femoral nerve of the dominant leg the athlete. Each stimulation will last 5 seconds with a 55 second period rest. (ARM2). The treatment will be delivered by an expert physical therapist with more than 10 years of experience in this technique.
- third group will be treated with the combination of both techniques after they finished the eccentric exercise circuit,24,48 and 72 hours after the exercises. First the trancranial magnetic stimulation protocol followed by the peripheral stimulation.(arm3). The treatment will be delivered by an expert physical therapist with more than 10 years of experience in this technique.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Rehabilitation

Comparator / control treatment

We will use a placebo group.
We will repeat the same protocol as in the intervention 3, combination of peripheral and transcranial magnetic stimulation. but we will apply the coils 15 cm over the stimulation point. This it has been demonstrated that it has no effect.

Control group

Placebo

Outcomes

Primary outcome [1]

quadriceps activation measured with superficial electromyography (Mdurance)

Timepoint [1]

before the intensive exercise
right after the intensive exercise (primary endpoint)
24 hours after intensive exercise
48 hours after intensive exercise
72 hours after intensive exercise

Primary outcome [2]

dynamometry to measure maximum isometric strength in quadriceps,
Measured in kilograms with the device ActiveForce 2 (Activbody, San Diego, CA.

Timepoint [2]

before the intensive exercise
right after the intensive exercise (primary endpoint)
24 hours after intensive exercise
48 hours after intensive exercise
72 hours after intensive exercise

Primary outcome [3]

Algometer to evaluate pain on vastus medalis,

Timepoint [3]

before the intensive exercise
right after the intensive exercise (primary endpoint)
24 hours after intensive exercise
48 hours after intensive exercise
72 hours after intensive exercise

Secondary outcome [1]

counter movement jump (CMJ)
measured with the app Myjump2 ( it is a primary outcome)

Timepoint [1]

before the intensive exercise
right after the intensive exercise (primary endpoint)
24 hours after intensive exercise
48 hours after intensive exercise
72 hours after intensive exercise

Secondary outcome [2]

30 meters sprint run. Measured with the app Mysprint. Measured in seconds. (This is a primary outcome)

Timepoint [2]

before the intensive exercise
right after the intensive exercise (primary endpoint)
24 hours after intensive exercise
48 hours after intensive exercise
72 hours after intensive exercise

Secondary outcome [3]

creatine kinase. Blood concentrations will be analyzed by electroenzymatic analysis (Lactate Scout Pro, Musimedic S.L Donostia, Spain). Subjects will be asked not to perform activities 2 days prior to the study due to the fact that this enzyme can rise up to days after having performed physical exercise.

Timepoint [3]

before the intensive exercise
right after the intensive exercise
24 hours after intensive exercise
48 hours after intensive exercise
72 hours after intensive exerrcise

Secondary outcome [4]

Lactate.
Lactate will also be collected by venous blood by puncture in the ear. This parameter will also be studied by electroenzymatic analysis (Lactate Scout Pro, Musimedic S.L Donostia, Spain). It will be collected before and after the intervention to induce the expected DOMS. Lactate allows obtaining more information regarding the basal state of the subject and the load that the work demanded and his subsequent recovery through the application of the treatment developed in our study.

Timepoint [4]

before the intensive exercise
right after the intensive exercise
24 hours after intensive exercise
48 hours after intensive exercise
72 hours after intensive exerrcise

Secondary outcome [5]

heart rate variability measured with a polar device. (primary outcome)

Timepoint [5]

before the intensive exercise
right after the intensive exercise (primary endpoint)
24 hours after intensive exercise
48 hours after intensive exercise
72 hours after intensive exercise

Secondary outcome [6]

HALF SQUAT, we will measure the speed developed while doing a half squat at a maximum speed in it concentric phase with an 80% of the weight of the sample subject, measured with an encoder (primary outcome)

Timepoint [6]

before the intensive exercise
right after the intensive exercise (primary endpoint)
24 hours after intensive exercise
48 hours after intensive exercise
72 hours after intensive exercise

Eligibility

Key inclusion criteria

Men between 18-35 years old.
• Practice sports activity at least 3 times a week for at least a year.
• Not having undergone surgery on the lower limb during the past 12 months.
• Not be a smoker.
• Not suffer a desensitization of the areas that will be treated with peripheral stimulation.
• Not having a pathology diagnosed as a chronic disease.
• Not having had a musculoskeletal injury in the lower extremities in the last 6 months.

Minimum age

18 Years

Maximum age

35 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Suffer desensitization in treatment areas with both peripheral and transcranial electromagnetic stimulation.
• Having some pathology that prevents physical activity.
• Subjects who would not have full cognitive abilities.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation was concealed by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomization of the groups will be carried out using the randomization function of Microsoft Office Excel (Microsoft Corporation, Redmond, Washington, USA).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The sample size was calculated using the G*Power 3.1.9.2 software (G*Power©, University of Dusseldorf. Germany) determining an effect size f = 0.20 with the error-a adjusted probability at 0.05, the power (the error-ß) at 20%, 4 groups and 5 measurements over time, a correlation level between repeated measurements of 0.3 and a sphericity correction of 0.5, resulting in a sample size of 96 subjects (N=96) with an equal distribution of 24 subjects for each study group.
Statistical tests will be carried out using the SPSS v.25 program (IBM, Armonk, NY, USA), Estudio v 4.0.3 package, and QIIME2 (R Core Team, 2020). To determine the normal distribution of the data, the Kolmogorov-Smirnov test will be used. For the quantitative variables, t tests will be carried out to compare the means of independent groups, to verify the homogeneity of the sample, the Mann-Whitney U test will be implemented to determine if there are significant differences in the sample and to observe its homogeneity. Initially, the groups will be described based on the group they belong to.
To study the effectiveness of the intervention, mixed multivariate analyzes of variance (Mauchly Sphericity) will be carried out, in which the independent variables will be the time of the study (T1, T2, T3, T4, T5) and the group. Mauchly's sphericity jointly assesses the mean differences of the dependent variables for the various categories of independent variables. Since sphericity will include two independent variables, the relationship of their main effects (time and group) separated, but also their interaction (time x group) will be studied.
The Mauchly sphericity test will be carried out on the dependent variables: Half Squat, force dynamometry, electromyography, visual analogue scale, algometer, counter movement jump, 30-meter run and heart rate variability. An analysis of variance (ANOVA) of repeated measures (5x6) will be performed to analyze the statistically significant intra- and inter-group differences. The effect size is estimated with partial eta squared, interpreting values of .01, .06, .14 as small, medium and large, respectively. The significance level of the study will be set at p < 0.05.
The results will be analyzed by means of a blind evaluator who will not participate in the data collection during the study, and who will not have information about the assignment of the subjects to each group.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

10/07/2023

Actual

Date of last participant enrolment

Anticipated

17/07/2023

Actual

Date of last data collection

Anticipated

10/08/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

MADRID

Funding & Sponsors

Funding source category [1]

University

Name [1]

Universidad Europea de Madrid

Address [1]

Universidad Europea de Madrid
calle tajo s/n Villaviciosa de Odón
28670 Madrid
Spain

Country [1]

Spain

Primary sponsor type

University

Name

Universidad Europea de Madrid

Address

Universidad Europea de Madrid
calle tajo s/n Villaviciosa de Odón
28670 Madrid
Spain

Country

Spain

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

hospital clínico San Carlos

Ethics committee address [1]

Profesor Martín Lagos, s/n. - Puerta G - 4a Norte
 Madrid 28040 Madrid España

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

01/02/2023

Approval date [1]

16/02/2023

Ethics approval number [1]

23/048-E

Summary

Brief summary

Delayed Onset Muscle Soreness (DOMS) is a recurring problem in sports, coaches and clinicians investigate its origin and try to find strategies to improve DOMS symptoms. Regarding the symptoms described DOMS can lead to a loss of joint amplitude up to 50%, as well as the force generated by the muscle,pain that is related to micro damage to muscle fibers induced by eccentric exercise. They also usually report a feeling of weakness that comes from the inflammation that appeared in the second phase. The most common is that they appear in a return to activity or in front of an unusual exercise, which generates a feeling of discomfort that can go as far as a decrease in performance, even the loss of the athlete. These symptoms usually lasts around 72 hours.
Due to the new theories about DOMS an it relationship with the peripheral and central nervous system, our hypothesis is that The combination of Peripheral Electromagnetic Stimulation therapy and Transcranial Electromagnetic Stimulation could improve performance through peripheral and central nervous system recovery in young athletes suffering from late-onset muscle soreness induced by eccentric exercise. After a protocol of eccentric exercise perform by healthy male athletes we will check the DOMS measuring the levels of creatinkinase and lactate in blood. The athletes will perform a dynamometric strength test, a CMJ test, a Half squat test, 30 meter sprint and we will record the EMG of the quadriceps to check activation and the heart rate variability. The athletes will be treated daily using peripheral or transcranial magnetic stimulation, a combination of both or a placebo. 
they will also be measured daily to see how the outcomes behave during the 3 days recovery period. We will have 4 groups measured 5 times

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Hugo Keriven

Address

Universidad Europea de Madrid
c/ tajo s/n 28670 Villaviciosa de Odón
Madrid
Spain

Country

Spain

Phone

+33 651896328

Fax

hugo.keriv@gmail.com

Contact person for public queries

Name

Alberto Sánchez SIerra

Address

Universidad Europea de Madrid
c/ tajo s/n 28670 Villaviciosa de Odón
Madrid
Spain

Country

Spain

Phone

+34 608 801238

Fax

alberto.sanchez@universidadeuropea.es

Contact person for scientific queries

Name

Alberto Sánchez SIerra

Address

Universidad Europea de Madrid
c/ tajo s/n 28670 Villaviciosa de Odón
Madrid
Spain

Country

Spain

Phone

+34 608801238

Fax

alberto.sanchez@universidadeuropea.es

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial

When will data be available (start and end dates)?

Immediately following publication, no end date

Available to whom?

any purpose,

Available for what types of analyses?

any purpose,

How or where can data be obtained?

by Principal Investigator
hugo.keriv@gmail.com

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details	Attachment
18652	Ethical approval	Alberto.sanchez@universidadeuropea.es	attached	385573-(Uploaded-22-03-2023-02-07-20)-Study-related document.pdf
18653	Study protocol	Alberto.sanchez@universidadeuropea.es		385573-(Uploaded-24-03-2023-00-01-27)-Study-related document.docx
18654	Informed consent form	Alberto.sanchez@universidadeuropea.es		385573-(Uploaded-24-03-2023-00-01-44)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of combined treatment with transcranial and peripheral electromagnetic stimulation on performance and pain recovery from delayed onset muscle soreness induced by eccentric exercise in young athletes. A randomized clinical trial.	2023	https://dx.doi.org/10.3389/fphys.2023.1267315

N.B. These documents automatically identified may not have been verified by the study sponsor.

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