Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2017
CompletedStudy Start
First participant enrolled
December 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2018
CompletedResults Posted
Study results publicly available
August 12, 2019
CompletedAugust 12, 2019
June 1, 2019
5 months
December 14, 2017
July 27, 2018
June 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Low Back Pain Perception (LBPP)
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.
Change between Baseline and 3 hours
Maximal Radial Displacement (Dm)
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.
Baseline and after 3 hours
Pressure Pain Threshold (PPT)
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.
Baseline and after 3 hours
Secondary Outcomes (1)
Roland-Morris Questionnaire (RMQ)
Baseline
Study Arms (2)
Road Cycling first, then Mountain Biking
ACTIVE COMPARATORFirst Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking).
Mountain Biking first, then Road Cycling
ACTIVE COMPARATORFirst Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Europea de Madrid
Villaviciosa de Odón, Madrid, 28670, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerson Garrosa Martín
- Organization
- Universidad Europea de Madrid
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gerson Garrosa Martín, PhD Candidate
Study Record Dates
First Submitted
December 14, 2017
First Posted
February 22, 2018
Study Start
December 14, 2017
Primary Completion
May 5, 2018
Study Completion
June 13, 2018
Last Updated
August 12, 2019
Results First Posted
August 12, 2019
Record last verified: 2019-06