Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-22 @ 4:15 PM
Study NCT ID:
NCT06433856
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2024-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Responses to Recovery Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-16', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle soreness', 'timeFrame': 'Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)', 'description': 'Subjective evalutation of muscle soreness from 0 to 10 with a numeric rating scale (NRS), where 0 is no soreness at all, and 10 is unbearable soreness'}, {'measure': 'Muscle fatigue', 'timeFrame': 'Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)', 'description': 'Subjective evaluation of muscle fatigue from 0 to 10 with a numeric rating scale (NRS), where 0 is no fatigue at all, and 10 is unbearable fatigue'}], 'secondaryOutcomes': [{'measure': 'Isometric muscle strength', 'timeFrame': 'Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)', 'description': 'Isometric knee extension (IKE) and flexion (IKF) strength assessments performed on a treatment bed, with a digital handheld dynamometer'}, {'measure': 'Tensiomyography', 'timeFrame': 'Within 10 minutes from exercise cessation (Post-Exercise); Within 10 minutes after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)', 'description': 'Tensiomyography (TMG) will be performed on anterior and posterior thigh muscles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['recovery', 'team sport', 'cryotherapy', 'massage guns'], 'conditions': ['Muscle Soreness']}, 'descriptionModule': {'briefSummary': 'Cold water immersion (CWI) and percussive massage therapy (PMT) are commonly used re-covery techniques in team sports. In particular, despite its wide use, PMT has been scarcely investigated in the literature, especially regarding neuromuscular measures and in comparison with other techniques. This study aims to evaluate and compare the acute and short-term ef-fects (24 h) of CWI and PMT on muscle strength, contractile properties, and soreness after exercise. A randomized crossover study will be performed on sixteen male soccer players (22 y, 20-27) who participate in three experimental sessions involving high-intensity training and 12-min recovery including CWI (10 °C water), bilateral PMT on the anterior and posterior thigh, or passive resting. Outcomes will be assessed immediately after the exercise protocol, after the recovery intervention, and at 24 h. Isometric knee extension (IKE) and flexion (IKF), and tensiomyography (TMG) will be assessed.Muscle soreness and fatigue will be scored from 0 to 10.', 'detailedDescription': 'Participants will be invited to participate to a cross-over randomized trial, consisting in 3 experimental sessions at 7 days of distance one from another. During each experimental session, participants will be asked to train for about 45 min at a high-intensity protocol (High-Intensity Intermittent Running, plyometric jumps and isometric chair position). After the exercise, participants will be assessed for neuromuscular function (isometric strength and tensiomyography) as well as perceived soreness and fatigue. Then, in a randomized order, participants will receive three different recovery interventions: cold water immersion, percussive massage, or a passive control condition. After the recovery intervention, outcomes are assessed again, as well as at 24 h. Isometric strength is assessed with a dynamometer during knee extension and knee flexion. Tensiomyography is performed on the thigh muscles, and time to contraction and radial displacement are considered as outcomes. Soreness and fatigue are rated by the participant from 0 to 10.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being healthy\n* training in soccer for more than 3 years and with a training frequency \\> 2 times/week\n\nExclusion Criteria:\n\n* reported time-loss injuries\n* using analgesics or other therapies affecting muscle function or pain'}, 'identificationModule': {'nctId': 'NCT06433856', 'briefTitle': 'Neuromuscular Responses to Recovery Techniques', 'organization': {'class': 'OTHER', 'fullName': 'University of Trieste'}, 'officialTitle': 'Effects of Cold Water Immersion and Percussive Gun Massage on Recovery Measures in Soccer Players', 'orgStudyIdInfo': {'id': 'Fisioterapia1705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CWI', 'description': "The CWI protocol consists of participants standing, with only their underwear and a t-shirt, in a portable tub for cold water therapy (Qryo, Italy), with the water to their hips being constantly maintained at 10±0.5 °C by a cooling system that pumped and stirred the water inside the tub and around the participant's lower limbs. Water temperature and the duration of the immersion, which is 12 minutes for all the participants considering they were characterized by similar anthropometrics and body composition, were based on previous literature", 'interventionNames': ['Other: Cold Water Immersion']}, {'type': 'EXPERIMENTAL', 'label': 'PMT', 'description': 'The PMT protocol is performed with the application of a percussive therapy gun (Theragun Elite, Therabody, USA). The participants rests with their underwear and a t-shirt on a treatment bed, and the percussive therapy gun with a "standard ball", 16 mm amplitude of percussions, and a frequency of 30 Hz, is applied to the thigh muscles of both lower limbs, 3 min on the anterior and 3 min on the posterior area of each thigh. The protocol is based on previous literature and adapted to the specific aims of this study.', 'interventionNames': ['Device: Percussive Massage Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'PAS', 'description': 'The control condition (PAS) consists of participants resting on a chair for 12 minutes in a quiet room at 25 °C.'}], 'interventions': [{'name': 'Cold Water Immersion', 'type': 'OTHER', 'description': 'Cold water immersion consists in 12 min standing in 10 °C water', 'armGroupLabels': ['CWI']}, {'name': 'Percussive Massage Therapy', 'type': 'DEVICE', 'description': 'Percussive massage therapy is performed with a massage gun on the thigh muscles for 12 min', 'armGroupLabels': ['PMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34100', 'city': 'Trieste', 'country': 'Italy', 'facility': 'CdL in Fisioterapia', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Trieste', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RTD-A', 'investigatorFullName': 'Alex Buoite Stella', 'investigatorAffiliation': 'University of Trieste'}}}}