Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-03 @ 11:46 PM
Study NCT ID:
NCT03170856
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2017-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'william.meehan@childrens.harvard.edu', 'phone': '781-216-1328', 'title': 'Dr. William Meehan', 'organization': "Boston Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Adverse event data were collected throughout each participant's enrollment in the study. This included at their initial visit, 4-weeks post injury, and 8-weeks post injury.", 'eventGroups': [{'id': 'EG000', 'title': 'Exercise Intervention Group', 'description': 'Thse patients will undergo a sub-maximal exercise training as treatment for concussion.\n\nSub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care Group', 'description': 'These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Concussed Participant Group', 'description': 'Participants who were enrolled in the study who were diagnosed with a sports-related concussion by a board certified sports medicine physician.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.031', 'spread': '0.013', 'groupId': 'OG000'}]}]}, {'title': '8-week', 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.010', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at initial visit and 8-weeks.', 'description': 'Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer.', 'unitOfMeasure': 'cm s-1 mmHg-1/mmHg CO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Concussed participants who completed exercise testing at baseline and 8-week visits.'}, {'type': 'PRIMARY', 'title': 'Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Intervention Group', 'description': 'These patients will undergo a sub-maximal exercise training as treatment for concussion.\n\nSub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.'}], 'classes': [{'title': 'Initial', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '42'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '35.5'}]}]}, {'title': '4weeks post injury', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '21.5'}]}]}, {'title': '8weeks post injury', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '27.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study.', 'description': 'Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem).', 'unitOfMeasure': 'score on the PSCI scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who reported sufficient exercise volume information during the duration of the study.'}, {'type': 'SECONDARY', 'title': 'End-tidal CO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Concussed Participant Group', 'description': 'Participants who were enrolled in the study who were diagnosed with a sports-related concussion by a board certified sports medicine physician.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '33.4', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': '8-week', 'categories': [{'measurements': [{'value': '33.2', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at initial visit and 8-week post injury visit.', 'description': 'Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits.', 'unitOfMeasure': 'mmHG', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants enrolled in the study who completed exercise testing sessions at baseline and 8-week post injury.'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Intervention Group', 'description': 'These patients will undergo a sub-maximal exercise training as treatment for concussion.\n\nSub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.'}], 'classes': [{'title': 'Baseline Baseline', 'categories': [{'measurements': [{'value': '162.5', 'spread': '19', 'groupId': 'OG000'}, {'value': '164.5', 'spread': '14.9', 'groupId': 'OG001'}]}]}, {'title': '4-Week', 'categories': [{'measurements': [{'value': '171.1', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '170', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': '8-Week', 'categories': [{'measurements': [{'value': '170.2', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '167.4', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.', 'description': 'Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed exercise testing at baseline, 4-week, and 8-week follow-up visits.'}, {'type': 'SECONDARY', 'title': 'Volume of Self-reported Exercise Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Intervention Group', 'description': 'These patients will undergo a sub-maximal exercise training as treatment for concussion.\n\nSub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '225'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '230'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Average volume of exercise (min) that was self-reported by participants over the 8-week study period.', 'description': 'Volume exercise was monitored by self-reported exercise diary. All participants were asked to track their exercise and complete weekly exercise logs for the 8-week study duration. The participants randomized into the Exercise Intervention Group were prescribed a specific heart rate to exercise 5x/week for 8-weeks. Heart rate was determined by their performance from the corresponding exercise testing visit. Participants enrolled in the Usual Care Group were not prescribed any specific exercise. These participants were instructed to follow their Doctors requests. Values are presented as average minutes of exercise throughout the 8-week study period.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who reported sufficient exercise volume information during the duration of the study.'}, {'type': 'SECONDARY', 'title': 'Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Intervention Group', 'description': 'Thse patients will undergo a sub-maximal exercise training as treatment for concussion.\n\nSub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.'}, {'id': 'OG001', 'title': 'Usual Care Group', 'description': 'These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '15.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': '4-Week', 'categories': [{'measurements': [{'value': '16.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': '8-Week', 'categories': [{'measurements': [{'value': '16.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic', 'description': 'Using the Borg Scale. The Borg scale is a way of measuring physical intensity level. The scale ranges from 6- no exertion at all, to 20- maximal exertion. The higher the RPE reported, the harder the participant perceives themselves to be physically working.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who reported RPE during initial, 4-week, and 8-week exercise tests.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exercise Intervention Group', 'description': 'Thse patients will undergo a sub-maximal exercise training as treatment for concussion.\n\nSub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.'}, {'id': 'FG001', 'title': 'Usual Care Group', 'description': 'These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment period: September 1, 2018 - November 1, 2020'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise Intervention Group', 'description': 'Thse patients will undergo a sub-maximal exercise training as treatment for concussion.\n\nSub-maximal exercise: Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.'}, {'id': 'BG001', 'title': 'Usual Care Group', 'description': 'These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '16.6', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '16.9', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who were enrolled in the study and randomized into the 2 intervention groups.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-16', 'size': 349379, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-30T08:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly assigned to either the exercise intervention group or the usual care group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2017-05-25', 'resultsFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2017-05-26', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-06', 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.', 'timeFrame': 'Measured at initial visit and 8-weeks.', 'description': 'Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer.'}, {'measure': 'Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.', 'timeFrame': 'The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study.', 'description': 'Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem).'}], 'secondaryOutcomes': [{'measure': 'End-tidal CO2', 'timeFrame': 'Measured at initial visit and 8-week post injury visit.', 'description': 'Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits.'}, {'measure': 'Heart Rate', 'timeFrame': 'Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.', 'description': 'Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits.'}, {'measure': 'Volume of Self-reported Exercise Per Week', 'timeFrame': 'Average volume of exercise (min) that was self-reported by participants over the 8-week study period.', 'description': 'Volume exercise was monitored by self-reported exercise diary. All participants were asked to track their exercise and complete weekly exercise logs for the 8-week study duration. The participants randomized into the Exercise Intervention Group were prescribed a specific heart rate to exercise 5x/week for 8-weeks. Heart rate was determined by their performance from the corresponding exercise testing visit. Participants enrolled in the Usual Care Group were not prescribed any specific exercise. These participants were instructed to follow their Doctors requests. Values are presented as average minutes of exercise throughout the 8-week study period.'}, {'measure': 'Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.', 'timeFrame': 'Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic', 'description': 'Using the Borg Scale. The Borg scale is a way of measuring physical intensity level. The scale ranges from 6- no exertion at all, to 20- maximal exertion. The higher the RPE reported, the harder the participant perceives themselves to be physically working.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Concussion, Mild', 'Concussion, Brain', 'Concussion, Severe', 'Exertion; Excess']}, 'referencesModule': {'references': [{'pmid': '30376513', 'type': 'BACKGROUND', 'citation': 'Howell DR, Taylor JA, Tan CO, Orr R, Meehan WP 3rd. The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Med Sci Sports Exerc. 2019 Apr;51(4):647-652. doi: 10.1249/MSS.0000000000001829.'}, {'pmid': '31198074', 'type': 'BACKGROUND', 'citation': 'Howell DR, Lugade V, Taksir M, Meehan WP 3rd. Determining the utility of a smartphone-based gait evaluation for possible use in concussion management. Phys Sportsmed. 2020 Feb;48(1):75-80. doi: 10.1080/00913847.2019.1632155. Epub 2019 Jun 26.'}, {'pmid': '31522997', 'type': 'BACKGROUND', 'citation': 'Howell DR, Brilliant AN, Oldham JR, Berkstresser B, Wang F, Meehan WP 3rd. Exercise in the first week following concussion among collegiate athletes: Preliminary findings. J Sci Med Sport. 2020 Feb;23(2):112-117. doi: 10.1016/j.jsams.2019.08.294. Epub 2019 Sep 7.'}, {'pmid': '31985574', 'type': 'BACKGROUND', 'citation': 'Howell DR, Oldham J, Lanois C, Koerte I, Lin AP, Berkstresser B, Wang F, Meehan WP 3rd. Dual-Task Gait Recovery after Concussion among Female and Male Collegiate Athletes. Med Sci Sports Exerc. 2020 May;52(5):1015-1021. doi: 10.1249/MSS.0000000000002225.'}, {'pmid': '31657636', 'type': 'BACKGROUND', 'citation': 'Howell DR, Brilliant AN, Meehan WP 3rd. Tandem Gait Test-Retest Reliability Among Healthy Child and Adolescent Athletes. J Athl Train. 2019 Dec;54(12):1254-1259. doi: 10.4085/1062-6050-525-18. Epub 2019 Oct 28.'}, {'pmid': '34320557', 'type': 'DERIVED', 'citation': 'Howell DR, Hunt DL, Oldham JR, Aaron SE, Meehan WP 3rd, Tan CO. Postconcussion Exercise Volume Associations With Depression, Anxiety, and Dizziness Symptoms, and Postural Stability: Preliminary Findings. J Head Trauma Rehabil. 2022 Jul-Aug 01;37(4):249-257. doi: 10.1097/HTR.0000000000000718. Epub 2021 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.', 'detailedDescription': 'There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment\n* Low or moderate cardiac risk according to American College of Sports Medicine\n* Post-Concussion Symptom Scale (PCSS) score greater than 9\n\nExclusion Criteria:\n\n* History of neurological surgery\n* Seizure disorder\n* Use of medication or medical device that would alter heart rate, blood pressure or autonomic function\n* Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity\n* Unable or unwilling to provide informed consent"}, 'identificationModule': {'nctId': 'NCT03170856', 'briefTitle': 'The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion', 'orgStudyIdInfo': {'id': 'P00024907'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Intervention Group', 'description': 'Thse patients will undergo a sub-maximal exercise training as treatment for concussion.', 'interventionNames': ['Other: Sub-maximal exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Group', 'description': 'These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician.'}], 'interventions': [{'name': 'Sub-maximal exercise', 'type': 'OTHER', 'description': 'Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.', 'armGroupLabels': ['Exercise Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'William Meehan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'William Meehan III', 'investigatorAffiliation': "Boston Children's Hospital"}}}}