Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-03 @ 9:54 PM
Study NCT ID:
NCT03314428
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-05
First Post:
2017-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Retraining for Runners with Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Data will be analyzed by an assessor blinded to date of data collection for each testing session. Following data collection, a researcher not involved with data collection or analysis will re-code data timepoints to ensure that the assessor is unaware of the timepoint each datapoint was obtained.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group cohort study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2017-10-13', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compliance with gait retraining change', 'timeFrame': 'During Week 1, 2, 3 and 4 of the retraining program', 'description': 'Compliance with instructions on step rate will be measured through data collected with the provided watch and a logbook. We will also monitor weekly running distance during the course of the study.'}, {'measure': 'Numeric pain rating scale for usual pain change', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months', 'description': 'Validated scale ranging from 0 (no pain) to 10 (worst imaginable pain), in which participants rate their level of pain during their usual daily activities over the previous week.'}, {'measure': 'Numeric pain rating scale for worst pain change', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months', 'description': 'Validated scale ranging from 0 (no pain) to 10 (worst imaginable pain), in which participants rate their worst level of pain over the previous week.'}], 'primaryOutcomes': [{'measure': 'Knee Osteoarthritis Outcome Score (KOOS) change', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months', 'description': 'Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis. The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.'}, {'measure': 'Peak knee adduction moment impulse change', 'timeFrame': 'Baseline, 4 weeks, 4 months', 'description': 'Validated surrogate measure of knee joint loading during movement. Expressed as Nm/kg\\*sec'}], 'secondaryOutcomes': [{'measure': 'Numerical pain rating scale for pain during running change', 'timeFrame': 'Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 4 months', 'description': 'Validated scale ranging from 0 (no pain) to 10 (worst imaginable pain), in which participants rate their worst level of pain during running over the previous week.'}, {'measure': 'Step rate change', 'timeFrame': 'Baseline, 4 weeks, 4 months', 'description': 'Number of steps taken during one minute of running.'}, {'measure': 'Peak knee flexion moment impulse change', 'timeFrame': 'Baseline, 4 weeks, 4 months', 'description': 'Validated surrogate measure of knee joint loading during running. Expressed as Nm/kg\\*sec'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Tibiofemoral osteoarthritis (TFOA) is highly prevalent in older adults, and often causes symptoms and functional limitations. Physical activity is widely advocated in people with TFOA, and running is an easy and accessible activity that provides many benefits on general health. However, running induces high knee loads, which could potentially contribute to symptoms of runners with TFOA. Previous studies have suggested that running gait modifications can help in decreasing symptoms and knee loading in runners with knee conditions. Yet, no study has been conducted in runners with TFOA. This intervention study will investigate the effects of a 4-week running gait retraining program on symptoms and running biomechanics in runners with TFOA. We hypothesize that running modifications will decrease symptoms, improve function and reduce knee loading.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TFOA of Grade 2 (mild) or 3 (moderate) on the Kellgren and Lawrence scale\n* report knee pain greater than or equal to 3/10 on a numerical pain rating scale (0-10) during most days of the previous month\n* run at least 10 km per week for a minimum of 6 months\n* declare being comfortable running on a treadmill for at least 30 minutes\n\nExclusion Criteria:\n\n* history of traumatic knee injury\n* neurological or inflammatory arthritic condition\n* cardiovascular or cardiopulmonary disease preventing from safely performing moderate intensity running\n* presence of any lower limb condition affecting running (other than TFOA)\n* use of any oral or injected corticosteroids or viscosupplementation in the previous six months\n* regular use of non-steroidal anti-inflammatory drugs, analgesics or knee unloading bracing devices before, during or after running\n* non-English speaking'}, 'identificationModule': {'nctId': 'NCT03314428', 'briefTitle': 'Gait Retraining for Runners with Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Effects of Gait Retraining in Runners with Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'H17-01228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gait retraining', 'description': 'Runners will be taught how to modify their running gait through multiple laboratory sessions and in-field training.', 'interventionNames': ['Behavioral: Gait retraining']}], 'interventions': [{'name': 'Gait retraining', 'type': 'BEHAVIORAL', 'description': 'Over a 4-week period, runners will be asked to increase their step rate to reduce knee loading during running. Specifically, they will have to increase their preferred step rate by 10% during weekly laboratory running sessions as well as during habitual running training. In the laboratory, runners will be provided with live visual/auditory biofeedback on step rate and asked to target a specific value representing 110% or preferred step rate. During their individual running sessions, runners will be wearing a GPS-enabled watch that will provide feedback on live step rate, and they will be asked to maintain the same value as in the laboratory.', 'armGroupLabels': ['Gait retraining']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'contacts': [{'name': 'Danmei Liu, PhD', 'role': 'CONTACT', 'email': 'danmei.liu@hiphealth.ca'}], 'facility': 'Robert H.N. Ho Research Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Jean-Francois Esculier, PT, PhD', 'role': 'CONTACT', 'email': 'jean-francois.esculier@ubc.ca', 'phone': '604-822-7948'}, {'name': 'Michael A Hunt, PT, PhD', 'role': 'CONTACT', 'email': 'michael.hunt@ubc.ca', 'phone': '604-822-7948'}], 'overallOfficials': [{'name': 'Michael A Hunt, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michael Hunt', 'investigatorAffiliation': 'University of British Columbia'}}}}