Trial Review

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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] 309228 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
impaired muscle activation 329385 0
pain 329386 0
muscle performance 330031 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326326 326326 0 0
Physiotherapy
Musculoskeletal 326937 326937 0 0
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] 325670 0
Treatment: Devices
Intervention code [2] 325671 0
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] 334182 0
quadriceps activation measured with superficial electromyography (Mdurance)
Timepoint [1] 334182 0
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] 334183 0
dynamometry to measure maximum isometric strength in quadriceps,
Measured in kilograms with the device ActiveForce 2 (Activbody, San Diego, CA.
Timepoint [2] 334183 0
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] 334184 0
Algometer to evaluate pain on vastus medalis,
Timepoint [3] 334184 0
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] 419746 0
counter movement jump (CMJ)
measured with the app Myjump2 ( it is a primary outcome)
Timepoint [1] 419746 0
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] 419747 0
30 meters sprint run. Measured with the app Mysprint. Measured in seconds. (This is a primary outcome)
Timepoint [2] 419747 0
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] 419748 0
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] 419748 0
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] 419749 0
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] 419749 0
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] 419750 0
heart rate variability measured with a polar device. (primary outcome)
Timepoint [5] 419750 0
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] 419862 0
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] 419862 0
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
96
Accrual to date
Final
Recruitment outside Australia
Country [1] 25336 0
Spain
State/province [1] 25336 0
MADRID

Funding & Sponsors
Funding source category [1] 313415 0
University
Name [1] 313415 0
Universidad Europea de Madrid
Country [1] 313415 0
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] 315224 0
None
Name [1] 315224 0
Address [1] 315224 0
Country [1] 315224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312631 0
hospital clínico San Carlos
Ethics committee address [1] 312631 0
Profesor Martín Lagos, s/n. - Puerta G - 4a Norte
Madrid 28040 Madrid España
Ethics committee country [1] 312631 0
Spain
Date submitted for ethics approval [1] 312631 0
01/02/2023
Approval date [1] 312631 0
16/02/2023
Ethics approval number [1] 312631 0
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 125350 0
Mr Hugo Keriven
Address 125350 0
Universidad Europea de Madrid
c/ tajo s/n 28670 Villaviciosa de Odón
Madrid
Spain
Country 125350 0
Spain
Phone 125350 0
+33 651896328
Fax 125350 0
Email 125350 0
hugo.keriv@gmail.com
Contact person for public queries
Name 125351 0
Dr Alberto Sánchez SIerra
Address 125351 0
Universidad Europea de Madrid
c/ tajo s/n 28670 Villaviciosa de Odón
Madrid
Spain
Country 125351 0
Spain
Phone 125351 0
+34 608 801238
Fax 125351 0
Email 125351 0
alberto.sanchez@universidadeuropea.es
Contact person for scientific queries
Name 125352 0
Dr Alberto Sánchez SIerra
Address 125352 0
Universidad Europea de Madrid
c/ tajo s/n 28670 Villaviciosa de Odón
Madrid
Spain
Country 125352 0
Spain
Phone 125352 0
+34 608801238
Fax 125352 0
Email 125352 0
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.TypeCitationLinkEmailOther DetailsAttachment
18652Ethical approval  Alberto.sanchez@universidadeuropea.es attached 385573-(Uploaded-22-03-2023-02-07-20)-Study-related document.pdf
18653Study protocol  Alberto.sanchez@universidadeuropea.es 385573-(Uploaded-24-03-2023-00-01-27)-Study-related document.docx
18654Informed 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
SourceTitleYear of PublicationDOI
EmbaseEffects 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.2023https://dx.doi.org/10.3389/fphys.2023.1267315
N.B. These documents automatically identified may not have been verified by the study sponsor.