Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT06201260
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2023-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intermittent Pneumatic Compression Following Exercise-induced Muscle Damaged
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-11-24', 'studyFirstSubmitQcDate': '2023-12-29', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal voluntary contraction (knee extension)', 'timeFrame': '10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention', 'description': 'Measures of isometric strength'}, {'measure': 'Countermovement jump', 'timeFrame': '10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention', 'description': 'Jump height'}, {'measure': 'Broad Jump', 'timeFrame': '10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention', 'description': 'Horizontal jump'}, {'measure': 'Soreness scale', 'timeFrame': '10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention', 'description': 'Likert scale of muscle soreness - the scale ranges from from 0 (a complete absence of soreness) to 6 (a severe pain that limits the ability to move)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sports Physical Therapy']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the recovery kinetics following an exercise-induced muscle damage activity (using flywheel) on active healthy university students.\n\nThe main questions are:\n\n\\- Is intermittent pneumatic compression superior to a placebo recovering from EIMD? Participants will perform a fatiguing protocol using flywheel and recover with either intermittent pneumatic compression or with a placebo treatment (micro-current treatment, but the device turned off). They will perform several performance tests before, following the recovery period, and at the 24h and 48h following the intervention'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '27 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male gender', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be eligible for participating in this study, participants should not have been recently injured, and should engage physical activity regularly (\\>3 times/week).\n\nExclusion Criteria:\n\n* Inactive participants\n* Younger than 18 years old or older than 27 years old'}, 'identificationModule': {'nctId': 'NCT06201260', 'acronym': 'IPC4sports', 'briefTitle': 'Effects of Intermittent Pneumatic Compression Following Exercise-induced Muscle Damaged', 'organization': {'class': 'OTHER', 'fullName': 'University of Maia'}, 'officialTitle': 'Effects of Intermittent Pneumatic Compression Following Exercise-induced Muscle Damaged', 'orgStudyIdInfo': {'id': 'PDFM_003'}, 'secondaryIdInfos': [{'id': 'IPC', 'type': 'OTHER', 'domain': 'University of Maia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPC', 'description': 'a 30 min high-pressure IPC protocol', 'interventionNames': ['Other: intermittent pneumatic compression protocol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'A 30 min placebo', 'interventionNames': ['Other: Placebo treatment']}], 'interventions': [{'name': 'intermittent pneumatic compression protocol', 'type': 'OTHER', 'description': 'A 30 min IPC protocol at about 200mmHg', 'armGroupLabels': ['IPC']}, {'name': 'Placebo treatment', 'type': 'OTHER', 'description': "The electrodes of an electrostimulation device (SP 4.0, Compex, Guildford, United Kingdom) will be positioned on participants' quadriceps. Participants will be informed that they are engaging an innovative microcurrent treatment. This procedure will last for 30 min.", 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4475-690', 'city': 'Maia', 'country': 'Portugal', 'facility': 'University of Maia', 'geoPoint': {'lat': 41.23574, 'lon': -8.6199}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Filipe Silvano Pinto Maia', 'investigatorAffiliation': 'University of Maia'}}}}