Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-25 @ 12:37 PM
Study NCT ID:
NCT04459195
Status:
COMPLETED
Last Update Posted:
2020-12-23
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Effects of Static Stretching Duration on Gastrocnemius Muscle Vascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-22', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle vascularization', 'timeFrame': 'Immediately after the application.', 'description': 'The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.'}, {'measure': 'Muscle vascularization', 'timeFrame': '10 minutes after the application.', 'description': 'The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastrocnemius', 'Static Stretching', 'Muscle Vascularization', 'Superb Microvascular Imaging'], 'conditions': ['Muscle Stretching Exercises']}, 'referencesModule': {'references': [{'pmid': '31063516', 'type': 'BACKGROUND', 'citation': 'Caliskan E, Akkoc O, Bayramoglu Z, Gozubuyuk OB, Kural D, Azamat S, Adaletli I. Effects of static stretching duration on muscle stiffness and blood flow in the rectus femoris in adolescents. Med Ultrason. 2019 May 2;21(2):136-143. doi: 10.11152/mu-1859.'}, {'pmid': '29238251', 'type': 'BACKGROUND', 'citation': 'Maeda N, Urabe Y, Tsutsumi S, Sakai S, Fujishita H, Kobayashi T, Asaeda M, Hirata K, Mikami Y, Kimura H. The Acute Effects of Static and Cyclic Stretching on Muscle Stiffness and Hardness of Medial Gastrocnemius Muscle. J Sports Sci Med. 2017 Dec 1;16(4):514-520. eCollection 2017 Dec.'}, {'pmid': '28988152', 'type': 'BACKGROUND', 'citation': 'Nakamura M, Ikezoe T, Nishishita S, Umehara J, Kimura M, Ichihashi N. Acute effects of static stretching on the shear elastic moduli of the medial and lateral gastrocnemius muscles in young and elderly women. Musculoskelet Sci Pract. 2017 Dec;32:98-103. doi: 10.1016/j.msksp.2017.09.006. Epub 2017 Sep 25.'}, {'pmid': '30953387', 'type': 'BACKGROUND', 'citation': 'Jiang ZZ, Huang YH, Shen HL, Liu XT. Clinical Applications of Superb Microvascular Imaging in the Liver, Breast, Thyroid, Skeletal Muscle, and Carotid Plaques. J Ultrasound Med. 2019 Nov;38(11):2811-2820. doi: 10.1002/jum.15008. Epub 2019 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'Stretching effects skeletal muscle flexibility, vascularity and physical performance. The aim of our study is to examine the acute effects of static stretching duration on gastrocnemius muscle vascularization in healthy participants by superb microvascular imaging (SMI) and to compare the effects of 2 and 5 minutes of static stretching on blood flow.', 'detailedDescription': 'The study will be included 30 healthy volunteers. The participants will be divided into two groups. Static stretching was administered to the gastrocnemius muscle. Stretching applications will be applied to the first group for 2 minutes and to the second group for 5 minutes. Muscle vascularization will be evaluated by a new method, superb microvascular imaging (SMI). SMI is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers between the ages of 18-35,\n* Without knee, hip, ankle and waist pathology,\n* Has not undergone any surgery on the lower extremity.\n\nExclusion Criteria:\n\n* Rheumatic, musculoskeletal, neurological and vestibular problems,\n* Bone pathologies,\n* Joint laxity,\n* Connective tissue disorders\n* Diabetes, metabolic syndrome, arthritic or inflammatory problems'}, 'identificationModule': {'nctId': 'NCT04459195', 'briefTitle': 'Acute Effects of Static Stretching Duration on Gastrocnemius Muscle Vascularization', 'organization': {'class': 'OTHER', 'fullName': 'Yuksek Ihtisas University'}, 'officialTitle': 'An Investigation of Acute Effects of Static Stretching Duration on Gastrocnemius Muscle Vascularization by Superb Microvascular Imaging Method', 'orgStudyIdInfo': {'id': 'Kamile U Akkaya'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 Minute Static stretching', 'description': 'Stretching applications will be applied to the first group for 2 minutes .', 'interventionNames': ['Behavioral: 2 Minute Static Stretching']}, {'type': 'EXPERIMENTAL', 'label': '5 Minute Static stretching', 'description': 'Stretching applications will be applied to the first group for 5 minutes.', 'interventionNames': ['Behavioral: 5 Minute Static Stretching']}], 'interventions': [{'name': '2 Minute Static Stretching', 'type': 'BEHAVIORAL', 'description': 'Stretching applications will be applied to the first group for 2 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.', 'armGroupLabels': ['2 Minute Static stretching']}, {'name': '5 Minute Static Stretching', 'type': 'BEHAVIORAL', 'description': 'Stretching applications will be applied to the first group for 5 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.', 'armGroupLabels': ['5 Minute Static stretching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Yuksek Ihtisas University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuksek Ihtisas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kamile UZUN AKKAYA', 'investigatorAffiliation': 'Yuksek Ihtisas University'}}}}