Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 3:46 PM
Study NCT ID:
NCT04972305
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of the Prevention Program Developed for Injuries in Recreational Cyclists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D006804', 'term': 'Ergonomics'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004738', 'term': 'Engineering'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'Body fat percentage will be determined by skinfold measurement'}, {'measure': 'Muscle strength', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'It will be measured with "1 max rep" (1RM).'}, {'measure': 'Flexibility', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'It will be evaluated with sit-reach test and modified ober test.'}, {'measure': 'Aerobic Capacity', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'It will be evaluated by shuttle run.'}, {'measure': 'Functional threshold power test (FTP)', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'It is obtained by calculating the force applied while pedaling for 20 minutes.'}, {'measure': 'Lactate threshold heart rate', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'Average heart rate taken while pedaling for 20 minutes.'}, {'measure': '10-Mile Trial Test', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'The time it takes to complete 10 miles in the fastest possible time is counted.'}, {'measure': 'Critical Power test', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'It is the estimation of the maximum effort that can be sustained for 3 minutes.'}, {'measure': 'Muscle myotonometric properties', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'It will be measured with myoton pro.'}, {'measure': 'Balance', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'It will be measured with Y balance test.'}], 'secondaryOutcomes': [{'measure': 'Perceived pain', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'It will be measured with McGill pain questionnaire'}, {'measure': 'İnjury', 'timeFrame': 'Change from Baseline at 12th weeks and 6th month', 'description': 'It will be measured with The Nordic musculoskeletal questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recreational cyclist', 'exercise', 'physical fitness', 'sports performance'], 'conditions': ['Sports Physical Therapy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the effects of personal ergonomic adaptations of the bicycle on the bicycle performance parameters, together with the exercise program training created to prevent biomechanical problems that cause injuries in recreational cyclist.', 'detailedDescription': "Considering the pandemic period we are living in, people are much more interested in health, sports and nature than they used to be. From this perspective, the interest in cycling, which can accommodate all of these features at the same time, is rapidly increasing. Individuals take bicycle rides in nature in their free time and make this activity a way of life. However, as in every physical activity, factors such as lack of knowledge in cycling, choosing the wrong bike and material, and not knowing the important basics of sports cause non-traumatic injuries in cyclists.\n\nWhile transitioning from the sedentary life brought by the age of technology to the activity, the musculoskeletal systems of individuals are caught unprepared and even exposed to various traumas and biomechanical problems. Because the looping motion of the lower extremities while cycling occurs primarily in the sagittal plane, power imbalances can develop that affect a cyclist's susceptibility to injury elsewhere along the kinetic chain. The most common areas of overuse injury in cycling are the knee, lumbar spine, cervical spine, hip, Achilles tendon, wrists, and forearm."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recreational cycling for at least 1 year\n* body mass index between 18.5-25 kg / m²\n* Obtaining a written health report stating "there is no harm in using a bicycle"\n\nExclusion Criteria:\n\n* History of fracture, trauma or surgery in the last 6 months\n* have any systemic or neurological problems'}, 'identificationModule': {'nctId': 'NCT04972305', 'briefTitle': 'The Impact of the Prevention Program Developed for Injuries in Recreational Cyclists', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'The Effect of the Prevention Program Developed for Injuries in Recreational Cyclists on Physical Performance and Physical Fitness Parameters', 'orgStudyIdInfo': {'id': 'YusufK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': '12 weeks exercise programme, 3 days a week Bicycle ergonomics will be applied.', 'interventionNames': ['Other: Exercise and ergonomics']}, {'type': 'EXPERIMENTAL', 'label': 'Ergonomics group', 'description': 'Bicycle ergonomics will be applied.', 'interventionNames': ['Other: Ergonomics']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No Intervention'}], 'interventions': [{'name': 'Exercise and ergonomics', 'type': 'OTHER', 'description': '12 week exercise and fit bike', 'armGroupLabels': ['Exercise group']}, {'name': 'Ergonomics', 'type': 'OTHER', 'description': 'Fit bike', 'armGroupLabels': ['Ergonomics group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27090', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Yusuf Şinasi Kirmaci', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'overallOfficials': [{'name': 'GÜNSELİ USGU', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hasan Kalyoncu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pt', 'investigatorFullName': 'YUSUF ŞİNASİ KIRMACI', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}