Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
Study NCT ID:
NCT03751150
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2018-11-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Injury Prevention Guidelines in Recreational Runners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001265', 'term': 'Athletic Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2018-11-16', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Injury occurence', 'timeFrame': '18 weeks', 'description': 'Incidence of running-related injuries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Running-related injury'], 'conditions': ['Sports Injury']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to investigate the effectiveness of specific training programs on the incidence of injuries in recreational runners. 408 runners between the ages of 18 and 55 years, will be recruited and randomly allocated to either the intervention group or control group. The intervention group will perform the training program twice a week in addition to their regular training. Injury data will be collected as the injuries occur and documentation of injury will follow a predetermined definition of injury. Participants will submit weekly reports of their running distance, frequency, running-related pain, as well as successful performance of the assigned training program for the intervention groups. The primary outcome is the incidence of injuries in all groups.', 'detailedDescription': 'Injuries and especially overuse injuries within recreational running are a common occurrence with higher incidence rates in novice runners but also in recreational runners training for a specific event. The mechanisms behind overuse injury development are thought to be multifactorial and certain parameters have shown to increase injury risk in recreational runners. The aim of this trial is to target these specific parameters and implement training programs to which recreational runners will adhere for a period of 18 weeks. About 408 male and female recreational runners, aged 18-55 years will be randomly allocated to one either the intervention (INT) or Control (CON).The INT group will perform an exercise program containing muscle control and foamrolling exercises in addition to their regular training, twice a week. The CON group will continue as per usual with their training. Training data will be collected on a weekly basis from all groups and pain and injury information will be submitted by the participants upon occurrence. The primary outcome measure is the number of sustained injuries in both groups. Participants will be recruited in December 2018 and the intervention will start in January 2019 for a period of 18 weeks, ending in May 2019. Data analyses are anticipated to be completed in September 2019.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female recreational runners with an average weekly running distance of at least 15km.\n\nExclusion Criteria:\n\n* Injury to the lower extremities during the past 6 months.'}, 'identificationModule': {'nctId': 'NCT03751150', 'briefTitle': 'Effectiveness of Injury Prevention Guidelines in Recreational Runners', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Effectiveness of Injury Prevention Guidelines in Recreational Runners', 'orgStudyIdInfo': {'id': 'SahgrenskaUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Normal training, no intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention INT', 'description': 'The intervention consists of an exercise program developed by a team specialised in orthopaedics, physiotherapy and biomechanics, based on the results from a recent prospective study in Gothenburg, Sweden. The exercises included cover muscle control training for the core, abductors, quadriceps and foot pronators, as well as foamrolling for the abductors, quadriceps, hamstrings, calf muscles and gluteal muscles. The runners will be instructed to perform the training program twice a week for the entire intervention period.', 'interventionNames': ['Other: Exercise program']}], 'interventions': [{'name': 'Exercise program', 'type': 'OTHER', 'description': 'The runners will be asked to perform the training program twice a week. The intervention consist of muscle control and foam rolling exercises for the lower extremities.', 'armGroupLabels': ['Intervention INT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41140', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Cenrte for Health and Performance', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Jòn Karlsson, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Sahlgrenska University Hospital'}, {'name': 'Stefan Grau, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Göteborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral Student', 'investigatorFullName': 'Pia Desai', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}