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

Primary Purpose

Physical Endurance, Muscle Fatigue, Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
3 hours Road Cycling Time Trial
3 hours Mountain Biking Time Trial
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Physical Endurance focused on measuring Muscle Fatigue, Cycling, MTB, Tensiomiography

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad Europea de Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Road Cycling first, then Mountain Biking

Mountain Biking first, then Road Cycling

Arm Description

First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking).

First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Roland-Morris Questionnaire (RMQ)
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.

Full Information

First Posted
December 14, 2017
Last Updated
June 27, 2019
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT03442933
Brief Title
Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles
Official Title
Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
May 5, 2018 (Actual)
Study Completion Date
June 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Endurance, Muscle Fatigue, Musculoskeletal Pain, Muscle Tightness
Keywords
Muscle Fatigue, Cycling, MTB, Tensiomiography

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Road Cycling first, then Mountain Biking
Arm Type
Active Comparator
Arm Description
First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking).
Arm Title
Mountain Biking first, then Road Cycling
Arm Type
Active Comparator
Arm Description
First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling).
Intervention Type
Other
Intervention Name(s)
3 hours Road Cycling Time Trial
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
3 hours Mountain Biking Time Trial
Intervention Description
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 Measure Information:
Title
Low Back Pain Perception (LBPP)
Description
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.
Time Frame
Change between Baseline and 3 hours
Title
Maximal Radial Displacement (Dm)
Description
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.
Time Frame
Baseline and after 3 hours
Title
Pressure Pain Threshold (PPT)
Description
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.
Time Frame
Baseline and after 3 hours
Secondary Outcome Measure Information:
Title
Roland-Morris Questionnaire (RMQ)
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Universidad Europea de Madrid
City
Villaviciosa De Odón
State/Province
Madrid
ZIP/Postal Code
28670
Country
Spain

12. IPD Sharing Statement

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

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