Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-03-21 @ 8:36 AM
Study NCT ID:
NCT03082651
Status:
COMPLETED
Last Update Posted:
2018-01-04
First Post:
2017-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternate Run Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-11-19', 'releaseDate': '2019-10-29'}], 'estimatedResultsFirstSubmitDate': '2019-10-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}], 'ancestors': [{'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-03', 'studyFirstSubmitDate': '2017-03-13', 'studyFirstSubmitQcDate': '2017-03-13', 'lastUpdatePostDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Running injuries', 'timeFrame': '13-weeks', 'description': 'When an participant misses 3 consecutive assigned running workouts.'}], 'secondaryOutcomes': [{'measure': 'Running-related pain', 'timeFrame': '13-weeks', 'description': '11-point numerical rating scale of overall pain associated with running'}, {'measure': 'Region specific running-related pain', 'timeFrame': '13-weeks', 'description': 'Numerical rating scale for pain at selected anatomical locations: gluteal, low back, groin, thigh, hamstring, knee, calf, Achilles, ankle, foot.'}, {'measure': 'Footwear comfort', 'timeFrame': '13-weeks', 'description': '11-point rating of footwear comfort'}, {'measure': 'Run Quality', 'timeFrame': '13-weeks', 'description': "Study specific 11-point measure of how the footwear used affected each run's quality"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Running injuries, footwear, alternating load'], 'conditions': ['Overuse Injury']}, 'descriptionModule': {'briefSummary': 'The proposed study will investigate the effect of alternating footwear model and workout-type on the occurrence of running-related pain. To achieve this goal participants will be randomly assigned into one of four different groups who will perform: 1) the same workout throughout a week in the same running shoe model, 2) alternating workout-types throughout the week in the same shoe model, 3) the same workout throughout a week in alternating shoe models, and 4) alternating workouts in alternating shoes. Participants will be characterized based on body alignment, strength, injury and training history. Pain and injury status will be monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects in this study will include adults (men and women) between the ages of 19 and 60, have been running on a regular basis (minimum once per week) over the past 6 months, are able to run for 60 minutes continuously, could tolerate 20-40km per week in training, and have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months. Only neutral and pronated foot postures (Foot Posture Index between -2 and 8) will be recruited\n\nExclusion Criteria:\n\n* have a history of surgery to their plantar fascia or Achilles tendon,\n* have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity,\n* take analgesic or anti-inflammatory medication 2 or more times per week over the past 4 weeks,\n* take part in high impact activities 2 or more times per week during the study period'}, 'identificationModule': {'nctId': 'NCT03082651', 'briefTitle': 'Alternate Run Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Investigating the Effect of Alternating Training Load and Footwear Singly or in Combination in Runners: The Alternate Run Study', 'orgStudyIdInfo': {'id': 'H16-00858'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Constant training/Constant footwear', 'description': 'Group 1 - Runners will be assigned identical training sessions over a 7-day period and will perform these runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus). The weekly training volume will increase on a weekly basis in order to progressively increase training load in preparation for the half-marathon event.', 'interventionNames': ['Other: Constant training', 'Other: Constant footwear']}, {'type': 'EXPERIMENTAL', 'label': 'Alternate training/Constant footwear', 'description': 'Group 2 - Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period. As with Group 1, weekly training volume will increase on a weekly basis. Runners in Group 2 will perform these runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).', 'interventionNames': ['Other: Alternating run training load', 'Other: Constant footwear']}, {'type': 'EXPERIMENTAL', 'label': 'Constant training/Alternating footwear', 'description': 'Group 3 - Runners will be assigned identical training sessions over a 7-day period but will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). The Zoom Streak has 10mm less midsole material, a less supportive heel counter and more flexible forefoot providing a more responsive feel to the runner.', 'interventionNames': ['Other: Alternating footwear', 'Other: Constant training']}, {'type': 'EXPERIMENTAL', 'label': 'Alternating training/Alternating footwear', 'description': 'Group 4 - Runners will be assigned a variation of workouts throughout each 7-day period and will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak).', 'interventionNames': ['Other: Alternating run training load', 'Other: Alternating footwear']}], 'interventions': [{'name': 'Alternating run training load', 'type': 'OTHER', 'description': 'Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period', 'armGroupLabels': ['Alternate training/Constant footwear', 'Alternating training/Alternating footwear']}, {'name': 'Alternating footwear', 'type': 'OTHER', 'description': 'Runners will be assigned identical training sessions over a 7-day period but will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). The Zoom Streak has 10mm less midsole material, a less supportive heel counter and more flexible forefoot providing a more responsive feel to the runner.', 'armGroupLabels': ['Alternating training/Alternating footwear', 'Constant training/Alternating footwear']}, {'name': 'Constant training', 'type': 'OTHER', 'description': 'Runners will be assigned identical training sessions over a 7-day period.', 'armGroupLabels': ['Constant training/Alternating footwear', 'Constant training/Constant footwear']}, {'name': 'Constant footwear', 'type': 'OTHER', 'description': 'Runners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).', 'armGroupLabels': ['Alternate training/Constant footwear', 'Constant training/Constant footwear']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T 1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Division of Sports Medicine', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Columbia Sports Medicine Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jack Taunton', 'investigatorAffiliation': 'University of British Columbia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-10-29', 'type': 'RELEASE'}, {'date': '2019-11-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jack Taunton, Professor, University of British Columbia'}}}}