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Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles

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ClinicalTrials.gov Identifier: NCT03442933
Recruitment Status : Completed
First Posted : February 22, 2018
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Gerson Garrosa Martín, Universidad Europea de Madrid

Brief Summary:

Introduction: Cycling represents a very important level of practice, being among the most practiced sports in Spain. As in any other sport discipline, its practice is associated with the appearance of overloads and sports injuries. Specifically, the 2 most affected areas are the lumbar and knee areas, with an annual prevalence of 58% and 36%, respectively. There is no clear hypothesis to explain the low back pain associated with the practice of cycling, but several authors agree that it may be due to holding an inverted posture of the rachis and the characteristics associated with this sport: long duration, static posture, high intensities, vibrations generated by the terrain, and so forth. The project proposes to analyze the acute effect of a long-lasting 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).

Objectives: 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 (LBP).


Condition or disease Intervention/treatment Phase
Physical Endurance Muscle Fatigue Musculoskeletal Pain Muscle Tightness Other: 3 hours Road Cycling Time Trial Other: 3 hours Mountain Biking Time Trial Not Applicable

Detailed Description:

A crossover randomized controlled trial. The participation in the study requires only 2 assistances to the data takings that will be developed in the training laboratory of the Faculty of Sciences of Physical Activity and Sport of the European University. 40 amateur cyclists will be randomly assigned to carry out each (2) conditions of intervention: a road bike time trial (CA) and a mountain bike time trial (MT) separated by 7 days washout. *Randomization marks the order in which participants are subjected to an intervention condition or other.

These sessions will begin with an initial assessment, which will be carried out: an anthropometric assessment (height and weight), followed to an evaluation of the tensiomyographic variable maximal radial displacement (Dm) over the thigh muscles: vastus medialis (VM), rectus femoris (RF), vastus lateralis (VL), biceps femoris (BF), and erector spinae (EE) at the lumbar level, before and after an acute effort (> 3 hours) in CA and MT bicycle. Respect to pain assessment, it will be measured the intensity pain perception on the lumbar region (LBPP) by using a 0 to 10 numeric pain-rating scale; the pressure pain threshold (PPT) with a manual mechanical algometer; and the functional disability caused by LBP through the Roland-Morris Questionnaire (RMQ).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A cross-over study with a single group (n = 40) of amateur cyclists subjected to each 2 different intervention conditions: a road bike time trial (CA) and a mountain bike time trial (MT).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles
Actual Study Start Date : December 14, 2017
Actual Primary Completion Date : May 5, 2018
Actual Study Completion Date : June 13, 2018

Arm Intervention/treatment
Active Comparator: Road Cycling first, then Mountain Biking
First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking).
Other: 3 hours Road Cycling Time Trial
The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic.

Other: 3 hours Mountain Biking Time Trial
The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.

Active Comparator: Mountain Biking first, then Road Cycling
First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling).
Other: 3 hours Road Cycling Time Trial
The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic.

Other: 3 hours Mountain Biking Time Trial
The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.




Primary Outcome Measures :
  1. Low Back Pain Perception (LBPP) [ Time Frame: Change between Baseline and 3 hours ]
    This variable records the intensity pain perceived on the lumbar region (LBPP) by using a 0 to 10 numeric pain-rating scale (NPRS). This is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). The LBPP was measured before and after completing each time trial.

  2. Maximal Radial Displacement (Dm) [ Time Frame: Baseline and after 3 hours ]
    The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in milimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect.

  3. Pressure Pain Threshold (PPT) [ Time Frame: Baseline and after 3 hours ]
    Measured from 0 to 10kg/cm2 with a manual mechanical algometer (FDK/FDN, Wagner Instruments, 1217 Greenwich, CT 06836), which has bilaterally shown an excellent reliability, reproducibility, and sensitivity on the lumbar erector spinae muscles.


Secondary Outcome Measures :
  1. Roland-Morris Questionnaire (RMQ) [ Time Frame: Baseline ]
    The functional disability caused by LBP through the Roland-Morris Questionnaire (RMQ). The score ranges from 0 to 24, with 0 indicating no disability and 24 maximum disability.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be a man
  • Aged between 18 and 55 years.
  • Minimum experience in the practice of cycling over 3 years
  • Accumulate at least 200 hours of training each year.
  • Not having received specific treatment in the musculature evaluated in the last 4 weeks, or being subjected to any treatment at present.
  • No pathology diagnosed in the anatomical regions interested in the study (lumbar, thigh, hip or knee).
  • Sign the informed consent.

Exclusion criteria

  • Have had strenuous exercise in the previous 48 hours
  • Having taken energy drinks in the last 48 hours
  • Have ingested alcohol or caffeine in the 3 hours prior to taking data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442933


Locations
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Spain
Universidad Europea de Madrid
Villaviciosa De Odón, Madrid, Spain, 28670
Sponsors and Collaborators
Universidad Europea de Madrid
  Study Documents (Full-Text)

Documents provided by Gerson Garrosa Martín, Universidad Europea de Madrid:

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Responsible Party: Gerson Garrosa Martín, Gerson Garrosa Martín, PhD Candidate, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT03442933     History of Changes
Other Study ID Numbers: 2016/UEM18
First Posted: February 22, 2018    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gerson Garrosa Martín, Universidad Europea de Madrid:
Muscle Fatigue
Cycling
MTB
Tensiomiography

Additional relevant MeSH terms:
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Fatigue
Musculoskeletal Pain
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations