Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-02-27 @ 4:09 PM
Study NCT ID:
NCT02076334
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2014-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise
Sponsor:
Organization:
Raw JSON
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{'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of study enrollment (3 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Compression + Normal Garment', 'description': 'Far Infrared Fabric during exercise + Spandex at night\n\nFar Infrared Fabric\n\nSpandex', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Normal Garment + Test Garment at Night', 'description': 'Spandex during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric\n\nSpandex', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Normal Garment + Normal Garment', 'description': 'Spandex during exercise + Spandex at night\n\nSpandex', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Test Garment + Test Garment', 'description': 'Far Infrared Fabric during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximal Voluntary Contraction (MVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compression + Normal Garment', 'description': 'Far Infrared Fabric during exercise + Spandex at night\n\nFar Infrared Fabric\n\nSpandex'}, {'id': 'OG001', 'title': 'Normal Garment + Test Garment at Night', 'description': 'Spandex during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric\n\nSpandex'}, {'id': 'OG002', 'title': 'Normal Garment + Normal Garment', 'description': 'Spandex during exercise + Spandex at night\n\nSpandex'}, {'id': 'OG003', 'title': 'Test Garment + Test Garment', 'description': 'Far Infrared Fabric during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric'}], 'classes': [{'categories': [{'measurements': [{'value': '182.4', 'spread': '45.7', 'groupId': 'OG000'}, {'value': '198.7', 'spread': '56.2', 'groupId': 'OG001'}, {'value': '208', 'spread': '70.5', 'groupId': 'OG002'}, {'value': '186.4', 'spread': '44.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 72 hours', 'unitOfMeasure': 'Newton-meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Creatine Kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Compression + Normal Garment', 'description': 'Far Infrared Fabric during exercise + Spandex at night\n\nFar Infrared Fabric\n\nSpandex'}, {'id': 'OG001', 'title': 'Normal Garment + Test Garment at Night', 'description': 'Spandex during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric\n\nSpandex'}, {'id': 'OG002', 'title': 'Normal Garment + Normal Garment', 'description': 'Spandex during exercise + Spandex at night\n\nSpandex'}, {'id': 'OG003', 'title': 'Test Garment + Test Garment', 'description': 'Far Infrared Fabric during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '140.6', 'spread': '40.4', 'groupId': 'OG000'}, {'value': '158.2', 'spread': '41.5', 'groupId': 'OG001'}, {'value': '181.2', 'spread': '40.4', 'groupId': 'OG002'}, {'value': '108.2', 'spread': '41.5', 'groupId': 'OG003'}]}]}, {'title': '24 H post', 'categories': [{'measurements': [{'value': '277.1', 'spread': '102.6', 'groupId': 'OG000'}, {'value': '458.5', 'spread': '105.2', 'groupId': 'OG001'}, {'value': '516.2', 'spread': '102.6', 'groupId': 'OG002'}, {'value': '332.8', 'spread': '105.2', 'groupId': 'OG003'}]}]}, {'title': '48 H post', 'categories': [{'measurements': [{'value': '225.8', 'spread': '127.3', 'groupId': 'OG000'}, {'value': '355.8', 'spread': '130.6', 'groupId': 'OG001'}, {'value': '542.9', 'spread': '127.3', 'groupId': 'OG002'}, {'value': '263.6', 'spread': '130.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 24 hrs and 48 hrs post', 'unitOfMeasure': 'u/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Compression + Normal Garment', 'description': 'Far Infrared Fabric during exercise + Spandex at night\n\nFar Infrared Fabric\n\nSpandex'}, {'id': 'FG001', 'title': 'Normal Garment + Test Garment at Night', 'description': 'Spandex during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric\n\nSpandex'}, {'id': 'FG002', 'title': 'Normal Garment + Normal Garment', 'description': 'Spandex during exercise + Spandex at night\n\nSpandex'}, {'id': 'FG003', 'title': 'Test Garment + Test Garment', 'description': 'Far Infrared Fabric during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'muscle soreness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Compression + Normal Garment', 'description': 'Far Infrared Fabric during exercise + Spandex at night\n\nFar Infrared Fabric\n\nSpandex'}, {'id': 'BG001', 'title': 'Normal Garment + Test Garment at Night', 'description': 'Spandex during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric\n\nSpandex'}, {'id': 'BG002', 'title': 'Normal Garment + Normal Garment', 'description': 'Spandex during exercise + Spandex at night\n\nSpandex'}, {'id': 'BG003', 'title': 'Test Garment + Test Garment', 'description': 'Far Infrared Fabric during exercise + Far Infrared Fabric at night\n\nFar Infrared Fabric'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '20.9', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '22.1', 'spread': '3.2', 'groupId': 'BG002'}, {'value': '21.0', 'spread': '2.5', 'groupId': 'BG003'}, {'value': '21', 'spread': '2.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-13', 'studyFirstSubmitDate': '2014-02-24', 'resultsFirstSubmitDate': '2017-01-19', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-13', 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Voluntary Contraction (MVC)', 'timeFrame': 'up to 72 hours'}], 'secondaryOutcomes': [{'measure': 'Creatine Kinase', 'timeFrame': 'baseline, 24 hrs and 48 hrs post'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['compression, isokinetic, far-infrared'], 'conditions': ['Muscle Damage']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/19222900', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To examine the influence of compression garments manufactured with Far-Infrared technology on exercise performance during and after repeated eccentric isokinetic muscle actions of the leg extensors.', 'detailedDescription': 'Participants: Eighty recreationally active (1-5 hrs per week) healthy participants between the ages of 18 - 35 will visit the Neuromuscular Research Laboratory on 6 separate occasions, with 4 of those occasions also requiring a visit to Health services for a blood draw.\n\nProcedures (methods): During pre-screening, each participant will complete an informed consent document, a health history questionnaire, and have their stature and body mass assessed. A familiarization session will then be conducted on a separate day where all participants will practice the strength assessment, eccentric isokinetic protocol, and ultrasound assessments. Participants will be assigned to 1 of the 4 treatment groups based on their initial maximal isometric strength values using a matched-participants design. The first experimental session will then begin 2-10 days later, where the participants will perform the repeated eccentric exercise protocol (10 sets of 15 eccentric contractions 210 deg/sec with 3 min of rest between sets) with the non-dominant leg following a 60 min rest period where they will wear the apparel and perform a 5 min warm-up on a cycle ergometer. Follow-up blood draws and strength and ultrasound assessments will be obtained at 24 and 48 hours post-exercise. Each participant will also complete a visual analog scale at baseline, 24, 48, and 72 hours post-exercise to examine perceived muscle soreness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cohort of Adult Males \\& Females\n* Participant is between the ages of 18-35\n* Healthy, Recreationally Active (1-5 hours per week)\n* Participant has provided written and dated informed consent to participate in the study\n* Participant is apparently healthy and free from disease, as determined by a health history questionnaire\n* Participant agrees to abstain from smoking, caffeine (4hrs prior), tobacco (24hrs prior), and alcohol (24 hrs) before testing days\n* Participant agrees to abstain from exercise 24 hours prior to each testing visit and after 72 hours of the induced exercise damage\n* Participant will refrain from the use of non-steroidal anti-inflammatory drugs (NSAIDs) and protein supplementation 24 hours before the exercise testing protocol, as well as for the 72 hour period following the exercise testing protocol.\n\nExclusion Criteria:\n\n* Participant is using, or has used one of the following dietary supplements within 12 weeks prior to enrollment: beta-alanine, creatine, taurine, or any supplemental antioxidants (Acai, pomegranate, beet juice).\n* Participant is in, or has participated in another clinical trial within 6 weeks prior to enrollment\n* Participant has a known allergy or sensitivity to test product (determined from health history questionnaire and consent form)'}, 'identificationModule': {'nctId': 'NCT02076334', 'briefTitle': 'Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Effect of Compression Garments on Exercise Performance Following Acute High Intensity Exercise', 'orgStudyIdInfo': {'id': '13-3101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Compression + normal garment', 'description': 'Far Infrared Fabric during exercise + Spandex at night', 'interventionNames': ['Other: Far Infrared Fabric', 'Other: Spandex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Garment + Test garment at night', 'description': 'Spandex during exercise + Far Infrared Fabric at night', 'interventionNames': ['Other: Far Infrared Fabric', 'Other: Spandex']}, {'type': 'SHAM_COMPARATOR', 'label': 'Normal Garment + normal garment', 'description': 'Spandex during exercise + Spandex at night', 'interventionNames': ['Other: Spandex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test garment + Test garment', 'description': 'Far Infrared Fabric during exercise + Far Infrared Fabric at night', 'interventionNames': ['Other: Far Infrared Fabric']}], 'interventions': [{'name': 'Far Infrared Fabric', 'type': 'OTHER', 'armGroupLabels': ['Compression + normal garment', 'Normal Garment + Test garment at night', 'Test garment + Test garment']}, {'name': 'Spandex', 'type': 'OTHER', 'armGroupLabels': ['Compression + normal garment', 'Normal Garment + Test garment at night', 'Normal Garment + normal garment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Exercise and Sport Science (University of North Carolina)', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Abbie Smith-Ryan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rhodia, Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}