Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05985967
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2023-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Modalities on Exercise Performance and Post-exercise Recovery of CrossFit® Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}, {'id': 'D048228', 'term': 'Intermittent Pneumatic Compression Devices'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in functional capacity', 'timeFrame': '1hour, 24 hours and 48 hours after WOD (workout of the day).', 'description': 'The functional capacity will be assessed through the maximum number of free squat repetitions performed within 1 minute.'}], 'secondaryOutcomes': [{'measure': 'Change in the activity of creatine kinase (CK)', 'timeFrame': '1 hour, 24 hours and 48 hours after WOD (workout of the day).', 'description': 'The activity of CK will be analyzed from the blood samples collected from the participants through spectrophotometry and using specific reagent kits.'}, {'measure': 'Change in the levels of interleukin-6 (IL-6)', 'timeFrame': '1 hour, 24 hours and 48 hours after WOD (workout of the day).', 'description': 'The levels of interleukin-6 will be analyzed from the blood samples collected from the participants through enzyme-linked immunosorbent assay (ELISA) and using specific reagent kits.'}, {'measure': "Participants' perceived exercise intensity", 'timeFrame': '1 minute after WOD (workout of the day), 1 minute post-treatment/intervention, 1 hour, 24 hours and 48 hours after WOD.', 'description': 'The perception of exercise intensity will be assessed through a 0-100 Ratings of Perceived Exertion Scale: in this scale lower score, means lower degree of fatigue and higher score, means higher degree of fatigue.'}, {'measure': "Participants' satisfaction regarding the interventions", 'timeFrame': '48 hours after WOD (workout of the day).', 'description': 'The participants satisfaction regarding the interventions will be assessed through the LIKERT scale'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Muscle Strength']}, 'descriptionModule': {'briefSummary': 'Crossfit® is a training modality that consists in functional movements, constantly varied and executed at high intensity. Both training sessions and competitions involve physically demanding activities, which in addition to being performed at very high intensity also involves the aerobic metabolism pathway. These characteristics led to very high metabolic and muscular stress, as well as decrease in physical performance immediately after competitions and training sessions. The cumulative effects of the metabolic and muscular stress can be a precursor of injuries. Studies using different therapeutic modalities aiming to improve post-exercise recovery are needed in order to tackle this issue.\n\nHowever, to the date there are no studies investigating the effects of different therapeutic modalities in an exercise modality such as Crossfit®. Therefore, the aim of this project is to assess the effects of different therapeutic modalities on performance and muscle recovery of Crossfit® athletes.', 'detailedDescription': 'It will be carried out a randomized, crossover, controlled trial.\n\nVolunteers will be allocated to four interventions, and the order of the interventions will be randomized.\n\nThe outcomes will be obtained at baseline (prior to the Workout of the Day - WOD), and in different timepoints after that.\n\nThe WOD will be consisted in finishing as quickly as possible a sequence of three exercises (Calories in Assault AirBike®, Hang Squat Clean and Box Jump Over), in a well-known series model for the athletes, without rest.\n\nThe investigators will analyze: the maximum number of free squats performed in 1 minute; the activity of creatine kinase (CK); the levels of Interleukin-6 (IL-6); the ratings of perceived exertion; and the volunteers satisfaction with the interventions.\n\nAll data will be analyzed both in their absolute values and in relation to their percentage variation from the values obtained in the pre-WOD (baseline) assessments.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Crossfit® amateur male athletes\n* Do not present a history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study;\n* Are not using pharmacological agents;\n* Athletes should have been practicing the sport for at least 1 year;\n* Voluntarily commit to participate in all stages of the study.\n\nExclusion Criteria:\n\n* Present musculoskeletal or joint injuries during data collection.'}, 'identificationModule': {'nctId': 'NCT05985967', 'briefTitle': 'Therapeutic Modalities on Exercise Performance and Post-exercise Recovery of CrossFit® Athletes', 'organization': {'class': 'OTHER', 'fullName': 'University of Nove de Julho'}, 'officialTitle': 'Therapeutic Modalities on Exercise Performance and Post-exercise Recovery of CrossFit® Athletes', 'orgStudyIdInfo': {'id': '3.997.120-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Passive recovery for 30 minutes', 'interventionNames': ['Other: Passive recovery']}, {'type': 'EXPERIMENTAL', 'label': 'PBMT-sMF', 'description': 'Photobiomodulation therapy combined with static magnetic field, with a total treatment duration lasting for around 30 minutes.', 'interventionNames': ['Device: PBMT-sMF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Shock wave', 'description': 'Shock wave therapy applied for 30 minutes.', 'interventionNames': ['Device: Shock wave']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pneumatic compression', 'description': 'Pneumatic compression applied for 30 minutes.', 'interventionNames': ['Device: Pneumatic compression']}], 'interventions': [{'name': 'PBMT-sMF', 'type': 'DEVICE', 'description': 'PBMT-sMF applied in the lower limbs with different doses per muscle group.', 'armGroupLabels': ['PBMT-sMF']}, {'name': 'Shock wave', 'type': 'DEVICE', 'description': 'Shock wave therapy applied in the lower limbs for 30 minutes.', 'armGroupLabels': ['Shock wave']}, {'name': 'Pneumatic compression', 'type': 'DEVICE', 'description': 'Pneumatic compression applied in the lower limbs for 30 minutes.', 'armGroupLabels': ['Pneumatic compression']}, {'name': 'Passive recovery', 'type': 'OTHER', 'description': 'Volunteers laid in supine position resting for 30 minutes.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01504-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Laboratory of Phototherapy and Innovative Technologies in Health', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Ernesto Cesar Pinto Leal Junior, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Full Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'The data will become available six months after the manuscript publication for five years after that.', 'ipdSharing': 'YES', 'description': 'Data will be shared upon request addressed to the principal investigator.', 'accessCriteria': 'All IPD that underlie results in a publication will be available on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nove de Julho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ernesto Cesar Pinto Leal Junior', 'investigatorAffiliation': 'University of Nove de Julho'}}}}