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

• Sponsor: Universidad Europea de Madrid (Other)
• Overall Status: Completed
• CT.gov ID: NCT03442933
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 6.7

Study Details

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).

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	N/A

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).

Study Design

• Study Type: Interventional
• 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).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: Dec 14, 2017
• Actual Primary Completion Date: May 5, 2018
• Actual Study Completion Date: Jun 13, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Low Back Pain Perception (LBPP) [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) [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) [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Europea de Madrid	Villaviciosa De Odón	Madrid	Spain	28670

Sponsors and Collaborators

• Universidad Europea de Madrid

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Mar 11, 2019

More Information

Publications

None provided.

• Responsible Party: Gerson Garrosa Martín, Gerson Garrosa Martín, PhD Candidate, Universidad Europea de Madrid
• ClinicalTrials.gov Identifier: NCT03442933
• Other Study ID Numbers: 2016/UEM18
• First Posted: Feb 22, 2018
• Last Update Posted: Aug 12, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gerson Garrosa Martín, Gerson Garrosa Martín, PhD Candidate, Universidad Europea de Madrid: Muscle Fatigue; Cycling; MTB; Tensiomiography
• Additional relevant MeSH terms: Musculoskeletal Pain; Fatigue

Study Results

Participant Flow

Recruitment Details	In total, 40 participants were randomly assigned to their Arm/Group, in which the intervention was administered in 2 different sequences of intervention: 1) Road Cycling first, then Mountain Biking; and 2) Mountain Biking first, then Road Cycling.
Pre-assignment Detail	They were required to attend on 2 different occasions to our installation, both spaced a week apart as washout.

Arm/Group Title	Road Cycling First, Then Mountain Biking	Mountain Biking First, Then Road Cycling.
Arm/Group Description	They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT.	They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT.
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Regardless of the Arm/Group in which the participants were initially assigned, all participants received all interventions. Therefore they are represented combined into one single Arm/Group.
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35 (8)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	40 100%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	40 100%
Region of Enrollment (Count of Participants)
Spain	40 100%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	177 (7)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	74.4 (8.9)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23.9 (1.9)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Amateur males from mixed cycling modalities with an experience in the practice of cycling greater than 3 years

Arm/Group Title	Road Cycling First, Then Mountain Biking	Mountain Biking First, Then Road Cycling
Arm/Group Description	First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking). 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. 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.	First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling). 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. 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.
Measure Participants	20	20
Baseline	1 (1.4)	0.8 (1.2)
After 3 hours	3.4 (2.2)	3.3 (2)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Road Cycling First, Then Mountain Biking	Mountain Biking First, Then Road Cycling.
Arm/Group Description	They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT.	They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT.
Measure Participants	20	20
Baseline	7.6 (2.1)	7.2 (2.2)
After 3 hours	9 (2.1)	8.8 (2.3)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Road Cycling First, Then Mountain Biking	Mountain Biking First, Then Road Cycling.
Arm/Group Description	They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT.	They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT.
Measure Participants	20	20
Baseline	5 (2)	4.7 (1.9)
After 3 hours	4.6 (1.9)	4.5 (1.8)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Study Participants
Arm/Group Description	Regardless of the Arm/Group in which the participants were initially assigned, all participants received all interventions. Therefore they are represented combined into one single Arm/Group.
Measure Participants	40
Score of 0	22 55%
Score of 1	9 22.5%
Score of 2	3 7.5%
Score of 3	2 5%
Score of 4	0 0%
Score of 5	1 2.5%
Score of 6	3 7.5%
Score of more than 6	0 0%

Adverse Events

Time Frame	All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.
Adverse Event Reporting Description	All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.
Arm/Group Title	Road Cycling First, Then Mountain Biking		Mountain Biking First, Then Road Cycling
Arm/Group Description	They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT.		They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT.
All Cause Mortality
	Road Cycling First, Then Mountain Biking		Mountain Biking First, Then Road Cycling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Road Cycling First, Then Mountain Biking		Mountain Biking First, Then Road Cycling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Road Cycling First, Then Mountain Biking		Mountain Biking First, Then Road Cycling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.