Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-18 @ 9:21 AM
Study NCT ID:
NCT06458166
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-06-01', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in Low frequency fatigue measured using Myocene (eletrical stimulus and force measurement)', 'timeFrame': '2 hours before the match; 30 minutes following the match, 24 hours following the match; 48 hours following the match', 'description': 'Assessment using myocene. Muscles are stimulated with low-frequency electrical pulses. The response of the muscle (force or torque) output, is recorded. A decrease in force output compared to baseline levels indicates fatigue.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sports', 'soccer', 'low frequency fatigue'], 'conditions': ['Fatigue', 'Physical Exercise']}, 'descriptionModule': {'briefSummary': 'Over the recent years, the increased competitive demands in elite competitive athletes has sparked a heightened interest in monitoring fatigue. Given the nature of the soccer game, athletes may experience low-frequency fatigue. Until recently, this assessment was restricted to in-lab. However, the emergence of new instruments aiming to allow low-frequency assessment to be carried out on a daily basis, in the context of professional teams. This study aimed to analyze the recovery of low-frequency fatigue, jump height and perceptual responses following competition and investigate possible associations between the objective and subjective parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Players at the highest division of the portuguese national championships in their respective age group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elite level youth soccer players, competing in the highest portuguese division\n\nExclusion Criteria:\n\n* Older adults\n* none elite soccer player\n* Play less than 70 minutes of match'}, 'identificationModule': {'nctId': 'NCT06458166', 'briefTitle': 'Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery', 'organization': {'class': 'OTHER', 'fullName': 'University of Maia'}, 'officialTitle': 'Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery in Youth Elite Soccer Players', 'orgStudyIdInfo': {'id': 'ST_S_'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Assessment of low frequency fatigue using low frequency eletrical stimulation', 'type': 'OTHER', 'description': 'Pre-programmed muscle electrical stimuli will be applied via Myocene® software using 3 electrodes: 1 cathode (5 x 10 cm) placed transversely over the proximal quadriceps femoris, and 2 anodes (5 x 5 cm) over the distal vastus medialis and vastus lateralis. Sixteen sets of stimuli will be administered with 5 seconds between sets. Each set consists of a single pulse, a train of 5 stimuli at 20 Hz, and a train of 18 stimuli at 120 Hz, with 1-second intervals between. The stimulation intensity starts at 25 mA and increases by 1 mA per set, reaching 40 mA in the final set. The Myocene® software calculates the ratio of low- to high-frequency evoked forces within each set. The outcome (Powerdex) is the median value of these 16 ratios for each leg. This evaluation will be conducted on both legs, taking 2 minutes per leg.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maia', 'state': 'Porto District', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Filipe Maia', 'role': 'CONTACT', 'email': 'fm.filipemaia@gmail.com', 'phone': '914957798'}], 'facility': 'University of Maia', 'geoPoint': {'lat': 41.23574, 'lon': -8.6199}}], 'centralContacts': [{'name': 'Filipe Maia', 'role': 'CONTACT', 'email': 'FMAIA.dcd@umaia.pt', 'phone': '22 986 6000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Filipe Silvano Pinto Maia', 'investigatorAffiliation': 'University of Maia'}}}}