Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-30 @ 8:09 PM
Study NCT ID:
NCT04367532
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foam Rolling and Tissue Flossing of the Cuff Muscles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be allocated to intervention (foam rolling, tissue flossing) or control group (without any intervention) using a randomized list of allocated numbers generated by a computer program. Investigator and Outcomes Assessor will be blinded to the allocation process.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in counter-movement jump (CMJ)', 'timeFrame': 'Baseline, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes', 'description': 'A maximum vertical jump with counter-movement.'}, {'measure': 'Change in 15-meter sprint run', 'timeFrame': 'Baseline, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes', 'description': 'The 15-meter sprint involves a participant starting behind a timing gate and running through a second timing gate 15 meters away.'}, {'measure': 'Change in viscoelastic properties of the Achilles tendon.', 'timeFrame': 'Baseline, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes', 'description': 'Stiffness measured on (1) Achilles tendon origin, (2) Achilles tendon on the center ankle joint, and (3) intermuscular septum between medial and lateral head of the gastrocnemius muscle.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['self myofascial release', 'injury prevention', 'performance', 'athletic training'], 'conditions': ['Ankle Injuries', 'Ankle Sprains']}, 'referencesModule': {'references': [{'pmid': '25883869', 'type': 'BACKGROUND', 'citation': 'Skarabot J, Beardsley C, Stirn I. Comparing the effects of self-myofascial release with static stretching on ankle range-of-motion in adolescent athletes. Int J Sports Phys Ther. 2015 Apr;10(2):203-12.'}, {'pmid': '29621115', 'type': 'BACKGROUND', 'citation': 'Smith JC, Pridgeon B, Hall MC. Acute Effect of Foam Rolling and Dynamic Stretching on Flexibility and Jump Height. J Strength Cond Res. 2018 Aug;32(8):2209-2215. doi: 10.1519/JSC.0000000000002321.'}, {'pmid': '28950149', 'type': 'BACKGROUND', 'citation': 'Driller M, Mackay K, Mills B, Tavares F. Tissue flossing on ankle range of motion, jump and sprint performance: A follow-up study. Phys Ther Sport. 2017 Nov;28:29-33. doi: 10.1016/j.ptsp.2017.08.081. Epub 2017 Aug 24.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis is that self-myofascial release (SMR) intervention on the cuff muscles would affect positively sprint performance and jump height, as well as, decrease Achilles tendon stiffness. The second hypothesis is that tissue flossing would be more effective than foam rolling.\n\nThe participants will be randomly assigned to foam rolling, tissue flossing, and control group (without any intervention). After the intervention, repeated measures will be performed (15m sprint, countermovement jump (CMJ) and Achilles tendon stiffness). This will aim to improve sprint time, jump height and decrease tendon stiffness.', 'detailedDescription': 'Foam rolling provides beneficial results in ankle range of motion, muscle flexibility or muscle sourness. Tissue flossing is popular in athletic training and physical therapy, as an effective strategy for ankle range of motion or performance. However, there is a lack of knowledge about the use of foam rolling and tissue flossing during a 60 minutes post-intervention examination on the performance and soft tissue stiffness.\n\nThe main aim of this study is to investigate the effect of foam rolling and tissue flossing of the cuff on sprint performance, jump height and Achilles tendon stiffness at different time points. The second aim is to assess the effectiveness of those self-myofascial release methods (SMR).\n\nThis study will include healthy, recreational active subjects aged between 20 and 25 years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Regular physical exercise activity (\\~3 times per week).\n\nExclusion Criteria:\n\n* Experience with the application of foam rolling and tissue flossing.\n* Current or prior pain or injury in the lower extremity.\n* Previous history of surgery in the lower extremity.\n* Cardiovascular disabilities.'}, 'identificationModule': {'nctId': 'NCT04367532', 'briefTitle': 'Foam Rolling and Tissue Flossing of the Cuff Muscles', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw University of Health and Sport Sciences'}, 'officialTitle': 'Foam Rolling and Tissue Flossing of the Cuff Muscles: Acute Effect on Jump Height, Sprint Performance and Achilles Tendon Stiffness', 'orgStudyIdInfo': {'id': 'USPEWroclaw'}, 'secondaryIdInfos': [{'id': '26/2016', 'type': 'OTHER', 'domain': 'University School of Physical Education in Wroclaw'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foam rolling', 'description': 'Foam rolling of cuff muscles.', 'interventionNames': ['Other: Foam rolling']}, {'type': 'EXPERIMENTAL', 'label': 'Tissue flossing', 'description': 'Tissue flossing of cuff muscles.', 'interventionNames': ['Other: Tissue flossing']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Without any intervention.'}], 'interventions': [{'name': 'Foam rolling', 'type': 'OTHER', 'description': 'Foam rolling performed on cuff muscles in 3 sets of 30 seconds per each muscle part in duration with a 15-second rest between sets. The first sets on the central part of the cuff muscles, the second on the medial and third on the lateral side of the cuff.', 'armGroupLabels': ['Foam rolling']}, {'name': 'Tissue flossing', 'type': 'OTHER', 'description': 'A standard cuff muscle bandaging technique on cuff muscle. After the application, each participant is asked to perform a 2 min ankle-exercise program.', 'armGroupLabels': ['Tissue flossing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51-612', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'University Team Sport Hall', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Adam Kawczyński, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University School of Physical Education in Wrocław'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw University of Health and Sport Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University', 'class': 'OTHER'}, {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Sebastian Klich', 'investigatorAffiliation': 'Wroclaw University of Health and Sport Sciences'}}}}