Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT04367727
Status:
UNKNOWN
Last Update Posted:
2020-11-25
First Post:
2020-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Light Emitting Diode Therapy on Muscle Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-21', 'studyFirstSubmitDate': '2020-01-24', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isometric peak torque of elbow flexors', 'timeFrame': 'change from before light emitting diode application at 5 minutes, 1 hour and 5 hours', 'description': 'metric unit is Newton'}, {'measure': 'Isometric peak torque of elbow flexors', 'timeFrame': 'change from before light emitting diode application at1 minute', 'description': 'metric unit is Newton'}, {'measure': 'Isokinetic peak torque of elbow flexors', 'timeFrame': 'change from before light emitting diode application at 5 minutes, 1 hour and 5 hours', 'description': 'Metric unit is Newton and at angular velocity 60'}, {'measure': 'Isokinetic peak torque of elbow flexors', 'timeFrame': 'change from before light emitting diode application at 1 minute after light emitting diode application', 'description': 'Metric unit is Newton and at angular velocity 60'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Fatigue']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the optimal time interval between light emitting diode application and exercise to improve fatigue resistance.The results of this study could be useful in planning a rehabilitation program in musculature disorders and also in athletic training.', 'detailedDescription': '1. To determine the effect of light emitting diode applied 5 minutes before exercise on pain, rate of perceived exertion and maximum voluntary contraction.\n2. To determine the effect of light emitting diode applied 1 hour before exercise on pain, rate of perceived exertion and maximum voluntary contraction.\n3. To determine the effect of light emitting diode applied 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.\n4. To determine the difference between light emitting diode applied 5 minutes,1 hour or 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy non athletics subjects.\n* Age ranges from 20-40 years.\n* Body mass index is less than 25 kg/m 2\n\nExclusion Criteria:\n\n* Neurological deficit and recent injury to either upper extremity\n* non diagnosed pain .\n* Contraindications to LED irradiation (such as light hypersensitivity, fluctuating blood pressure, insufficient blood circulation, fever and inflammation of the skin)\n* Conditions in which physical exertion is contraindicated (such as cardiovascular deficits, hypertension and respiratory problems)\n* Restriction in shoulder or elbow range of motion;\n* Neoplasm,\n* Rheumatoid,\n* Strength training in the past 6 months;\n* Previous surgery in the spine or upper extremity;\n* Complaints of pain in the shoulder, elbow,wrist, and trunk musculature system;\n* Use of dietary supplements; and not in any other exercise program for at least the past 3 months.'}, 'identificationModule': {'nctId': 'NCT04367727', 'acronym': 'LED', 'briefTitle': 'Effect of Light Emitting Diode Therapy on Muscle Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Different Pre Application Time Intervals of Light Emitting Diode Therapy on Muscle', 'orgStudyIdInfo': {'id': 'P.T.REC/012/002480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5 minutes before 1', 'description': 'Light emitting diode applied 5 minutes before fatiguing task', 'interventionNames': ['Device: Light emitting diode']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5 minutes before 2', 'description': 'Light emitting diode applied 5 minutes before fatiguing task', 'interventionNames': ['Device: Light emitting diode']}, {'type': 'EXPERIMENTAL', 'label': '1 hour before 1', 'description': 'Light emitting diode applied 1 hour before fatiguing task', 'interventionNames': ['Device: Light emitting diode']}, {'type': 'PLACEBO_COMPARATOR', 'label': '1 hour before 2', 'description': 'Light emitting diode applied 1 hour before fatiguing task', 'interventionNames': ['Device: Light emitting diode']}, {'type': 'EXPERIMENTAL', 'label': '5 hours before 1', 'description': 'Light emitting diode applied 5 hours before fatiguing task', 'interventionNames': ['Device: Light emitting diode']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5 hours before 2', 'description': 'Light emitting diode applied 5 hours before fatiguing task', 'interventionNames': ['Device: Light emitting diode']}], 'interventions': [{'name': 'Light emitting diode', 'type': 'DEVICE', 'description': 'Light emitting diode at a wavelength of 890 nm is produced by an array of 60 gallium aluminum arsenide light-emitting diodes located on flexible pads and the near infrared photo energy is delivered in a noninvasive, drug-free manner', 'armGroupLabels': ['1 hour before 1', '1 hour before 2', '5 hours before 1', '5 hours before 2', '5 minutes before 1', '5 minutes before 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'HAhmed', 'investigatorAffiliation': 'Cairo University'}}}}