Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-04 @ 5:32 PM
Study NCT ID:
NCT03281668
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2017-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility of High Intensity Interval Training in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'golight@email.unc.edu', 'phone': '919-966-0566', 'title': 'Yvonne Golightly, PhD', 'organization': 'University of North Carolina at Chapel Hill/Thurston Arthritis Research Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This was a single arm study so it is not known how HIIT compares to other exercise approaches or interventions for the management of knee OA.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from Baseline through the 12 week follow-up visit (an overall total of 12 weeks).', 'description': 'Lab team members who became aware of any adverse event or unanticipated problems related to the study were to notify the PIs immediately. All adverse events and study-related safety events were collected by the study team. Aggregated unanticipated problems and adverse events were reviewed on a monthly basis, or more often if urgent matters arose.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Potential Participants Screened for the Study Who Are Enrolled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Number of participants screened and enrolled divided by the total number of participants screened', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Enrolled Participants Retained at the End of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study completion (12 weeks)', 'description': 'Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Number of Training Sessions Completed Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly measures for 12 consecutive weeks', 'description': 'Up to 2 training sessions were possible each week over the 12 week intervention', 'unitOfMeasure': 'training sessions per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Training Sessions Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '7.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)', 'unitOfMeasure': 'training sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Number of Training Weeks Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '1.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Total number of training weeks (up to 12 weeks possible)', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.2', 'groupId': 'OG000', 'lowerLimit': '-13.6', 'upperLimit': '-4.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,12 weeks', 'description': 'The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.', 'unitOfMeasure': 'percentage change in score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Pain Subscale From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '-0.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,12 weeks', 'description': 'The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.', 'unitOfMeasure': 'percentage change in score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Function Subscale From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'groupId': 'OG000', 'lowerLimit': '-9.6', 'upperLimit': '-3.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.', 'unitOfMeasure': 'percentage change in score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in 20m Fast Paced Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.13', 'groupId': 'OG000', 'lowerLimit': '-1.61', 'upperLimit': '-0.64'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Originally planned to have participants perform 40-meter walk; however, due to lab space constraints, this was altered to a 20-meter walk instead.'}, {'type': 'SECONDARY', 'title': 'Change in Number of Chair Stand Repetitions Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '3.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Number of chair stand repetitions completed in 30 seconds', 'unitOfMeasure': 'number of chair stands', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Stair Climb Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.42', 'groupId': 'OG000', 'lowerLimit': '-2.13', 'upperLimit': '-0.71'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Time in seconds to ascend and descend a flight of stairs', 'unitOfMeasure': 'change in seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Timed Up and Go', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'groupId': 'OG000', 'lowerLimit': '-0.95', 'upperLimit': '-0.22'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down', 'unitOfMeasure': 'change in seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Feet Together Stand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Feet together stand for up to 10 seconds without assistive device', 'unitOfMeasure': 'change in seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were able to complete Feet Together Stand at baseline and 12 weeks (no change).'}, {'type': 'SECONDARY', 'title': 'Change in Semi-tandem Stand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '1.23'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds', 'unitOfMeasure': 'change in seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Tandem Stand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'groupId': 'OG000', 'lowerLimit': '-0.33', 'upperLimit': '1.11'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'One foot in front of the other, heel touching toe, for up to 10 seconds', 'unitOfMeasure': 'change in seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in One Leg Stand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.41', 'groupId': 'OG000', 'lowerLimit': '0.26', 'upperLimit': '6.56'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'One leg stand for up to 30 seconds', 'unitOfMeasure': 'change in seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Cardiorespiratory Fitness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.24'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.', 'unitOfMeasure': 'change in liters/minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Whole Body Fat Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'groupId': 'OG000', 'lowerLimit': '-1.10', 'upperLimit': '0.54'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.12', 'groupId': 'OG000', 'lowerLimit': '-0.56', 'upperLimit': '0.31'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'lean body mass in kilograms, measured with DXA', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Visceral Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000', 'lowerLimit': '-0.40', 'upperLimit': '0.02'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'visceral fat in kilograms, measured with DXA', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Knee Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'classes': [{'title': 'Right knee flexors', 'categories': [{'measurements': [{'value': '3.34', 'groupId': 'OG000', 'lowerLimit': '-0.74', 'upperLimit': '7.41'}]}]}, {'title': 'Left knee flexors', 'categories': [{'measurements': [{'value': '-0.84', 'groupId': 'OG000', 'lowerLimit': '-6.36', 'upperLimit': '4.69'}]}]}, {'title': 'Right knee extensors', 'categories': [{'measurements': [{'value': '9.99', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '18.18'}]}]}, {'title': 'Left knee extensors', 'categories': [{'measurements': [{'value': '9.86', 'groupId': 'OG000', 'lowerLimit': '0.40', 'upperLimit': '19.33'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors', 'unitOfMeasure': 'change in maximum kilograms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'scheduling conflict, family circumstance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.\n\nHigh intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '6.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-08', 'size': 820771, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-01T15:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-04', 'studyFirstSubmitDate': '2017-08-31', 'resultsFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-04', 'studyFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Potential Participants Screened for the Study Who Are Enrolled', 'timeFrame': 'Baseline', 'description': 'Number of participants screened and enrolled divided by the total number of participants screened'}, {'measure': 'Percentage of Enrolled Participants Retained at the End of the Study', 'timeFrame': 'Study completion (12 weeks)', 'description': 'Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments'}], 'secondaryOutcomes': [{'measure': 'Average Number of Training Sessions Completed Per Week', 'timeFrame': 'Weekly measures for 12 consecutive weeks', 'description': 'Up to 2 training sessions were possible each week over the 12 week intervention'}, {'measure': 'Total Number of Training Sessions Completed', 'timeFrame': '12 weeks', 'description': 'Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)'}, {'measure': 'Total Number of Training Weeks Completed', 'timeFrame': '12 weeks', 'description': 'Total number of training weeks (up to 12 weeks possible)'}, {'measure': 'Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks', 'timeFrame': 'Baseline,12 weeks', 'description': 'The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.'}, {'measure': 'Change in WOMAC Pain Subscale From Baseline to 12 Weeks', 'timeFrame': 'Baseline,12 weeks', 'description': 'The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.'}, {'measure': 'Change in WOMAC Function Subscale From Baseline to 12 Weeks', 'timeFrame': 'Baseline, 12 weeks', 'description': 'The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.'}, {'measure': 'Change in 20m Fast Paced Walk Test', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.'}, {'measure': 'Change in Number of Chair Stand Repetitions Completed', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Number of chair stand repetitions completed in 30 seconds'}, {'measure': 'Change in Stair Climb Test', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Time in seconds to ascend and descend a flight of stairs'}, {'measure': 'Change in Timed Up and Go', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down'}, {'measure': 'Change in Feet Together Stand', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Feet together stand for up to 10 seconds without assistive device'}, {'measure': 'Change in Semi-tandem Stand', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds'}, {'measure': 'Change in Tandem Stand', 'timeFrame': 'Baseline, 12 weeks', 'description': 'One foot in front of the other, heel touching toe, for up to 10 seconds'}, {'measure': 'Change in One Leg Stand', 'timeFrame': 'Baseline, 12 weeks', 'description': 'One leg stand for up to 30 seconds'}, {'measure': 'Change in Cardiorespiratory Fitness', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.'}, {'measure': 'Change in Whole Body Fat Mass', 'timeFrame': 'Baseline, 12 weeks', 'description': 'fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)'}, {'measure': 'Change in Lean Body Mass', 'timeFrame': 'Baseline, 12 weeks', 'description': 'lean body mass in kilograms, measured with DXA'}, {'measure': 'Change in Visceral Fat', 'timeFrame': 'Baseline, 12 weeks', 'description': 'visceral fat in kilograms, measured with DXA'}, {'measure': 'Change in Knee Strength', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee osteoarthritis'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based high intensity interval training program (HIIT) to improve physical function in patients with knee osteoarthritis (OA).', 'detailedDescription': 'All participants will be assigned to the single-arm of the study in which all participants will receive 12 weeks of HIIT, delivered twice per week. The primary outcome will examine the feasibility and acceptability of the 12 week HIIT program in patients with knee OA symptoms ranging from mild to severe. The investigators will determine adherence to and tolerability of HIIT, acceptability, and recruitment and retention rates during the 12 week program. Additional outcomes will include physical function, knee OA symptomatic burden (pain), static standing balance, isometric knee extensor and flexor strength, cardiorespiratory fitness, and body composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between the ages of 40 and 75 years old\n* body mass index of 18.5-50 kg/m²\n* exhibits symptomatic knee OA, defined as a diagnosis of knee OA, as identified from University of North Carolina electronic medical records, and current knee symptoms in at least one knee, having a minimum score of 6 out of 20 on the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale.\n\nExclusion Criteria:\n\n* individuals diagnosed with a cardiovascular condition restricting exercise\n* individuals currently meeting Department of Health and Human Services Guidelines for physical activity (≥ 150 minutes per week\n* individuals currently doing HIIT\n* individuals currently participating in physical therapy for knee OA\n* individuals currently participating in another OA intervention study\n* received a corticosteroid or hyaluronic acid intra-articular injection in the knee during the previous 3 weeks or scheduled for during the intervention\n* diagnosis of gout in the knee\n* diagnosis of rheumatoid arthritis\n* diagnosis of fibromyalgia\n* other systemic rheumatic disease\n* severe dementia or other memory loss\n* active diagnosis of psychosis or uncontrolled substance abuse disorder\n* hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months\n* total joint replacement knee surgery, other knee surgery, meniscus tear, or anterior cruciate ligament (ACL) tear in the past 6 months\n* on a waiting list for total joint replacement\n* severely impaired hearing or speech\n* pregnant or planning to become pregnant while enrolled in the study\n* inability to speak English\n* serious or terminal illness as indicated by referral to hospice or palliative care\n* nursing home residence\n* inability to ride a stationary bike\n* any other health problems that would prohibit safe participation in the study\n* EKG results EKG suggesting the individual would not be able to safely participate in this study'}, 'identificationModule': {'nctId': 'NCT03281668', 'briefTitle': 'Feasibility of High Intensity Interval Training in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Feasibility of High Intensity Interval Training in Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '16-2996'}, 'secondaryIdInfos': [{'id': '1R21HD088852-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD088852-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.', 'interventionNames': ['Behavioral: High intensity interval training (HIIT)']}], 'interventions': [{'name': 'High intensity interval training (HIIT)', 'type': 'BEHAVIORAL', 'description': 'Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Yvonne Golightly, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}