Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT03442933
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2017-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'g.garrosa@gmail.com', 'phone': '+34 663 294 774', 'title': 'Gerson Garrosa Martín', 'phoneExt': '0034', 'organization': 'Universidad Europea de Madrid'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.', 'description': 'All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Road Cycling First, Then Mountain Biking', '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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mountain Biking First, Then Road Cycling', 'description': '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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Low Back Pain Perception (LBPP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Road Cycling First, Then Mountain Biking', 'description': 'First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking).\n\n3 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.\n\n3 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.'}, {'id': 'OG001', 'title': 'Mountain Biking First, Then Road Cycling', 'description': 'First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling).\n\n3 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.\n\n3 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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'After 3 hours', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between Baseline and 3 hours', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Amateur males from mixed cycling modalities with an experience in the practice of cycling greater than 3 years'}, {'type': 'PRIMARY', 'title': 'Maximal Radial Displacement (Dm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Road Cycling First, Then Mountain Biking', '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.'}, {'id': 'OG001', 'title': 'Mountain Biking First, Then Road Cycling.', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.6', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'After 3 hours', 'categories': [{'measurements': [{'value': '9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 3 hours', '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.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pressure Pain Threshold (PPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Road Cycling First, Then Mountain Biking', '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.'}, {'id': 'OG001', 'title': 'Mountain Biking First, Then Road Cycling.', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5', 'spread': '2', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'After 3 hours', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and after 3 hours', '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.', 'unitOfMeasure': 'kg/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Roland-Morris Questionnaire (RMQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants', '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.'}], 'classes': [{'categories': [{'title': 'Score of 0', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Score of 1', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Score of 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Score of 3', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Score of 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Score of 5', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Score of 6', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Score of more than 6', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Road Cycling First, Then Mountain Biking', '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.'}, {'id': 'FG001', 'title': 'Mountain Biking First, Then Road Cycling.', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': 'They were required to attend on 2 different occasions to our installation, both spaced a week apart as washout.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '177', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'spread': '8.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'spread': '1.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Amateur males from mixed cycling modalities with an experience in the practice of cycling greater than 3 years.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-11', 'size': 317451, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-03-12T12:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-27', 'studyFirstSubmitDate': '2017-12-14', 'resultsFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2018-02-21', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-27', 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Low Back Pain Perception (LBPP)', 'timeFrame': 'Change between Baseline and 3 hours', '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.'}, {'measure': 'Maximal Radial Displacement (Dm)', 'timeFrame': 'Baseline and after 3 hours', '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.'}, {'measure': 'Pressure Pain Threshold (PPT)', 'timeFrame': 'Baseline and after 3 hours', '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.'}], 'secondaryOutcomes': [{'measure': 'Roland-Morris Questionnaire (RMQ)', 'timeFrame': 'Baseline', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle Fatigue', 'Cycling', 'MTB', 'Tensiomiography'], 'conditions': ['Physical Endurance', 'Muscle Fatigue', 'Musculoskeletal Pain', 'Muscle Tightness']}, 'descriptionModule': {'briefSummary': '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).\n\nObjectives: 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).', 'detailedDescription': '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.\n\nThese 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).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be a man\n* Aged between 18 and 55 years.\n* Minimum experience in the practice of cycling over 3 years\n* Accumulate at least 200 hours of training each year.\n* Not having received specific treatment in the musculature evaluated in the last 4 weeks, or being subjected to any treatment at present.\n* No pathology diagnosed in the anatomical regions interested in the study (lumbar, thigh, hip or knee).\n* Sign the informed consent.\n\nExclusion criteria\n\n* Have had strenuous exercise in the previous 48 hours\n* Having taken energy drinks in the last 48 hours\n* Have ingested alcohol or caffeine in the 3 hours prior to taking data.'}, 'identificationModule': {'nctId': 'NCT03442933', 'briefTitle': 'Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': 'Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles', 'orgStudyIdInfo': {'id': '2016/UEM18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Road Cycling first, then Mountain Biking', 'description': 'First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking).', 'interventionNames': ['Other: 3 hours Road Cycling Time Trial', 'Other: 3 hours Mountain Biking Time Trial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mountain Biking first, then Road Cycling', 'description': 'First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling).', 'interventionNames': ['Other: 3 hours Road Cycling Time Trial', 'Other: 3 hours Mountain Biking Time Trial']}], 'interventions': [{'name': '3 hours Road Cycling Time Trial', 'type': 'OTHER', '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.', 'armGroupLabels': ['Mountain Biking first, then Road Cycling', 'Road Cycling first, then Mountain Biking']}, {'name': '3 hours Mountain Biking Time Trial', 'type': 'OTHER', '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.', 'armGroupLabels': ['Mountain Biking first, then Road Cycling', 'Road Cycling first, then Mountain Biking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28670', 'city': 'Villaviciosa de Odón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Europea de Madrid', 'geoPoint': {'lat': 40.3581, 'lon': -3.9043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gerson Garrosa Martín, PhD Candidate', 'investigatorFullName': 'Gerson Garrosa Martín', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}