Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-27 @ 4:51 AM
Study NCT ID:
NCT04628403
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2020-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Clinical Interventions for the Management of Late Start
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008405', 'term': 'Massage'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'the results assessor will not be aware of the subject allocation group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-12', 'studyFirstSubmitDate': '2020-10-26', 'studyFirstSubmitQcDate': '2020-11-12', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAIN', 'timeFrame': '7 days', 'description': 'pain systemic and located in quadriceps, assessed using a visual analog scale (0-10), with 0 indicating no pain and 10 the worst possible pain'}, {'measure': 'SATISFACTION', 'timeFrame': '7 days', 'description': "Brunel's Mood Scale (BRUMS), with ratings from 0 to 4 where, 0 represents nothing; 1 represents a little, 2 indicates moderately; 3 reports a lot; and 4 corresponds to extremely"}], 'secondaryOutcomes': [{'measure': 'MUSCLE STRENGTH', 'timeFrame': '7 days', 'description': 'measured through a functional test entitled sit and stand. It is a test initially developed by researchers at UFRJ that consists of asking the subject to try to sit and stand in sequence, with the guidance of not using any support, for example the help of the hands or knees to obtain additional balance, leaving thus, that the musculature alone performs the function recruited'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lasertherapy', 'Shockwaves', 'Massage', 'Sports Medicine', 'Athletic Performance'], 'conditions': ['Athletes']}, 'descriptionModule': {'briefSummary': 'Introduction: Late-onset muscle pain (DOMS) is characterized by a type of temporary muscle damage, common after high-intensity exercise. In addition to pain, DOMS clinically generates muscle stiffness, reduced joint range of motion, muscle weakness and reduced peak torque. In this regard, in order to accelerate the recovery of body systems and treat symptoms of DOMS, the management of different types of interventions has been observed, supporting the clinical practice, based on evidence. Objectives: To investigate the effect of different types of clinical interventions for the treatment of DOMS. Material and methods: For the clinical trial, 50 ultramarathon and rowing athletes of both sexes, aged between 18 and 60 years old, will be recruited randomly into four possible groups: control (CG), shock waves (G1) , massage (G2) and laser therapy (G3). The evaluation moments will be as follows: minutes before exercise (M1); immediately after exercise (M2); immediately after applying the recovery technique (M3); and 24 hours after exercise (M4) and the evaluated outcomes will be: pain, psychological aspects, functional test and blood markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Professional athletes;\n* Age over 18 years;\n* Both sexes;\n* Not having recent injuries\n\nExclusion Criteria:\n\n* Participants who do not complete all the proposed collection moments\n* who do not agree to participate will be excluded.'}, 'identificationModule': {'nctId': 'NCT04628403', 'briefTitle': 'Effects of Clinical Interventions for the Management of Late Start', 'organization': {'class': 'OTHER', 'fullName': 'São Paulo State University'}, 'officialTitle': 'Effects of Clinical Interventions for the Management of Late Start Muscular Pain (Doms) in the Post-exercise Recovery Process', 'orgStudyIdInfo': {'id': 'UNIRIO_STUDY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control'}, {'type': 'EXPERIMENTAL', 'label': 'shock waves', 'interventionNames': ['Device: shock waves']}, {'type': 'EXPERIMENTAL', 'label': 'massage', 'interventionNames': ['Other: massage']}, {'type': 'EXPERIMENTAL', 'label': 'lasertherapy', 'interventionNames': ['Device: lasertherapy']}], 'interventions': [{'name': 'massage', 'type': 'OTHER', 'description': 'clinical interventions, of mechanophysiological origin for the treatment of symptoms corresponding to DOMS, after exercise', 'armGroupLabels': ['massage']}, {'name': 'lasertherapy', 'type': 'DEVICE', 'description': 'lasertherapy', 'armGroupLabels': ['lasertherapy']}, {'name': 'shock waves', 'type': 'DEVICE', 'description': 'shock waves', 'armGroupLabels': ['shock waves']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78060-900', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'contacts': [{'name': 'Roberto L Nahon, Dr', 'role': 'CONTACT', 'email': 'robertonahon@gmail.com', 'phone': '66999202206'}, {'name': 'Jaqueline S Lopes', 'role': 'CONTACT', 'email': 'jaqueee-santosss@hotmail.com', 'phone': '+5566999202206'}], 'facility': 'Universidade Federal do Estado do Rio de Janeiro', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'centralContacts': [{'name': 'Roberto L Nahon, Dr', 'role': 'CONTACT', 'email': 'robertonahon@gmail.com', 'phone': '+5521981112880'}, {'name': 'Jaqueline S Lopes, Dra', 'role': 'CONTACT', 'email': 'jaqueee-santosss@hotmail.com', 'phone': '+8069221843'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'São Paulo State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}