Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles
Phase: NA
Conditions: Physical Endurance, Muscle Fatigue, Musculoskeletal Pain, Muscle Tightness
Sponsor: Universidad Europea de Madrid

 
 
 
 
 
 
Official Title of the study: 
 
 
Assessment of the Acute Effect of 
Cycling Practice in Lumbar and Thigh 
Muscles 
 
NCT number: NCT03442933 
 
 
 
 
Date of the document: 11/03/2019 
 

I. Study Protocol  
 
The main objective of this study is to evaluate the behavior of the mechanical characteristics of 
the lower back and thigh muscles, by means of tensiomyography, in amateur cyclists after an 
acute effort on road and mountain bikes, and to study their possible relationship with low back 
pain. Material and methods: Cross-sectional randomized clinical trial. A single group (n = 40) of 
amateur cyclists was set up and subjected to 2 different intervention conditions: a road bike 
time trial (CA) and a mountain bike time trial (MT). The behavior of the mechanical 
characteristics of the musculature of the lower back and thigh, in amateur cyclists, before and 
after an acute effort (> 3 hours) in CA and MT bicycle, was evaluated using the tensiomyographic 
variables of delay time (Td), contraction time (Tc), maximal radial displacement (Dm), relaxation 
time (Tr) and sustain time (Ts). The thigh muscles selected from the thigh were: vastus medialis 
(VM), rectus femoris (RF), vastus lateralis (VL), biceps femoris (BF), and erector spinae (EE) at 
the lumbar level. Pain assessment was carried out using the perceived pain scale (EVA), the 
pressure pain threshold (UDP) and the Roland-Morris questionnaire (RMQ).  
 
II. Statistical Analysis Plan  
 
The statistical analysis was performed with the SPSS v.21. To assess the effect of cycling practice 
on the mechanical characteristics of the muscles, a multivariate analysis (MANOVA) was 
performed. The level considered significant was established at 0.05 in all the analysis carried 
out. 
 
 

III. Informed Consent Form 
 
FACT SHEET PARTICIPANTS 
 
ESTUDY TITTLE: “Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles”.  
PROMOTER OF THE STUDY: 
 
Name: Gerson Garrosa Martín  
             Telephone: 663 294 774                e-mail: g.garrosa@gmail.com 
 
Through this document the recipient is invited to participate in a research study promoted by the 
European University of Madrid on the acute response of the muscles of the back and thigh in road and 
mountain bikers. Before deciding whether to participate in this study, it is important that you understand 
why this research is necessary, which will involve your participation, how your information will be used 
and its possible benefits, risks and discomforts. Please take the time to read carefully the information 
provided below. 
STUDY SUMMARY: 
The two most important problems of the musculoskeletal system in cyclists are low back pain (60%) and 
knee pain (33%). There is no clear hypothesis about the development of low back pain in cyclists, but 
several authors agree that it may be due to maintaining a maintained posture, with the lumbar spine in 
inversion and the characteristics associated with this sport (long duration, static posture, high intensities 
The project proposes to analyze the acute effect of a long-term bicycle trip (  3 hours) on the muscles 
involved in low back and knee pain, see, lumbar paravertebral, quadriceps and hamstrings, by means of 
tensiomyography (TMG) . 
VOLUNTARY PARTICIPATION AND WITHDRAWAL OF THE STUDY: 
The participation in the study is totally voluntary, being possible to withdraw from it at any time, without 
altering the investigator-participant relationship, nor any damage as a result of that relationship. 
In case you decide to leave the study, the participant may do so by allowing the use of the data obtained 
so far for the purpose of the study or, if it were his will, these data would be erased from the computer 
files. 
 
 

Who can participate? 
 
It is required to meet the following inclusion criteria: be a man, with an age between 18 and 55 years, 
with an experience in the practice of cycling over 3 years, having accumulated at least 200 hours of 
training annually. Not having received specific treatment for the lumbar area in the last 4 weeks, or, being 
subjected to any treatment currently in evaluated musculature, and not suffering from pathology 
diagnosed in the anatomical regions interested in the study. And, finally, sign the informed consent. 
 
Excluded criteria will have been to have performed strenuous exercise in the previous 48 hours, as well 
as having taken energy drinks, alcohol or caffeine in the 3 hours prior to the data collection; Do not 
complete the bike ride due to loss in the course or suffer any mechanical failure that prevents the 
continuity of the same. 
 
What is the participation of each subject? 
The participation in the study requires only 2 assistances to the data takings, separated by a week among 
themselves, that will be developed in the training laboratory of the Faculty of Sciences of Physical Activity 
and Sport of the European University. Each participant will be evaluated under two conditions: road cyclist 
and mountain cyclist. Said sessions will begin with an initial assessment, in which an anthropometric 
assessment (height and weight), an assessment of pain perceived with the EVA scale and the pain 
threshold with algometry will be made. A muscular evaluation with tensiomyography, a non-invasive tool 
that allows us to evaluate the contractile properties of superficial muscles through an isometric 
contraction induced by electrostimulation, and the assessment of mobility and flexibility of the lumbar 
spine. 
Once the initial assessment is complete, participants will perform a brief 5-minute warm-up on a 
stationary bicycle by replicating the measurements of their bicycle. They will repeat, once again, the initial 
evaluations and will make an exit by bicycle through a previously programmed route and of an 
approximate duration of 3 hours. Upon their return, the participants will re-perform all previous 
assessments. 
Requirements to the participants for the day of the evaluation 
Participants are asked to attend the data collection fully rested, having made the trip to the facilities by 
car and never by bicycle. Otherwise, this could affect the initial measurements. Bring your own bicycle 
with you since the weight and height and back of the saddle and handlebars will be recorded. They come 
with shaved legs, and bring a sports shorts and shirt for measurements, because, if for example the 
measurements are made in quadriceps with the rolled up colutte, the pressure exerted by this on the 

musculature would affect the results It is recommended to bring a towel to dry the sweat at the end of 
the exit. All participants can change at the same facilities, as well as take a shower at the end. 
BENEFITS AND RISKS DERIVED FROM PARTICIPATION IN THE STUDY 
 
Your participation in the study can help you to control risk factors associated with sports injuries in the 
practice of cycling and, therefore, to optimize sports performance and maintain a healthy state. It is 
expected that the information obtained may benefit other cyclists in the future and may contribute to a 
better understanding of the muscle contraction process and that this may be related to the presence of 
back pain. 
The assessments of the study will not pose any risk to your health. As for the electrical stimulation of the 
Tensiomyography, it is very low intensity, In any case, the stimulus intensity that can reach the 
electrostimulator does not exceed 110 milliamps, well below the minimum value for this type of current, 
direct current, may cause ventricular fibrillation. It can only be a little unpleasant at the time of muscle 
stimulation. As for the departure by bike, the risks inherent in the practice of cycling are well known: 
injuries, falls, collisions, etc. At the end of the investigation you can be informed, if you wish, about the 
main results and the general conclusions of the study. 
The investigators in charge of performing the tensiomyographic assessments have experience in the use 
of the Tensiomyography. Likewise, one of the members of the research team is a member of the 
International Society of Tensiomyography (ISOT). 
 
CONFIDENTIALITY 
 
The treatment, communication and transfer of personal data of all participating subjects will comply with 
the provisions of Organic Law 15/1999, of December 13, on the Protection of Personal Data. In accordance 
with the aforementioned legislation, you can exercise the rights of access, modification, opposition and 
cancellation of data, for which you should contact the study sponsor. 
 
The data collected for the study will be identified by a code and only the principal investigator of the study 
/ collaborators will be able to relate said data with you. Therefore, your identity will not be disclosed to 
any person except for exceptions of legal requirement. 
 
ECONOMIC COMPENSATION 
 
No type of financial compensation is expected during the study. 
 
 
 

OTHER RELEVANT INFORMATION 
 
If you decide to withdraw your consent to participate in this study, no new data will be added to the 
database and you may demand the destruction of your data and / or all identifiable samples previously 
held to prevent further analysis. 
You should also know that you can be excluded from the study if the investigators consider it appropriate, 
either for security reasons, for any adverse event that occurs or because you believe that you are not 
complying with the established procedures. In either case, you will receive an adequate explanation of 
the reason for your withdrawal from the study. By signing the consent form, you agree to comply with 
the study procedures that have been presented to you. 
 
QUESTIONS 
 
If you have any questions about any aspect of the study or would like to comment on some aspect of this 
information, please do not hesitate to ask the members of the research team. In case after reading this 
information and clarifying the doubts, decide to participate in the study, you must sign your informed 
consent. 
 
 
INFORMED CONSENT OF PARTICIPATION IN THE STUDY  
“Assessment Of The Acute Effect Of Cycling Practice In Lumbar And Thigh Muscles” 
 
Participants name: 
_______________________________________________________________________ 
 
I have read the information sheet, I have understood the explanations given to me, as 
well as the possible complications and risks. Therefore, I declare to be correctly 
informed according to the provisions of article 4 of Law 41/2002, of November 14, and 
I give my consent to participate in the research study. 
 
Place and Date:    _________ in __________ of 20 __ 
Signature: _________________ 
National identity document: _________________ 
 
Informed Consent Template version 4.0 11/03/2019