Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-29 @ 6:24 AM
Study NCT ID:
NCT05710757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2023-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Proximal Muscle Strength Effects by Incorporating Proximal Muscle Lengthening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089803', 'term': 'Myofascial Release Therapy'}, {'id': 'D000090003', 'term': 'Blood Flow Restriction Therapy'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The control group will receive a sham intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The control group will receive a sham myofascial release pectoralis minor release intervention. The experimental group will receive a myofascial release pectoralis minor release intervention. Both groups will receive blood flow restriction exercise to strength the scapula retractors.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length for the pectoralis minor', 'timeFrame': '8 weeks', 'description': 'Assess length of the pectoralis minor with a tape measure'}], 'primaryOutcomes': [{'measure': 'Scapular retraction strength', 'timeFrame': '8 weeks', 'description': 'Assess scapular retraction strength with a dynamometer'}], 'secondaryOutcomes': [{'measure': 'One repetition maximum (1RM)', 'timeFrame': '8 weeks', 'description': 'maximum amount of weight that can be lifted one time for scapular retractors on a row machine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['blood flow restriction', 'myofascial release'], 'conditions': ['Proximal Muscle Strength', 'Proximal Muscle Lengthening']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess strength gains of proximal musculature in the nondominant upper extremity after implementing blood flow restriction (BFR) and myofascial release (MFR) with the supplementation of whey protein.', 'detailedDescription': 'The purpose of this study is to assess strength gains of proximal musculature in the nondominant upper extremity after implementing blood flow restriction (BFR) and myofascial release (MFR) with the supplementation of whey protein. Blood flow restricted (BFR) exercise is the brief and non-continuous blockage of venous blood flow using a device that restricts the flow of blood while exercising. This technique is used to produce hypertrophy (muscle growth) and strength responses while exercising at a lighter load than traditionally required to produce a similar response. Myofascial release (MFR) is a technique that involves applying gentle sustained pressure into the myofascial connective tissue restrictions to eliminate pain and restore motion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals between the age of 18 and 30\n\nExclusion Criteria:\n\n* Individuals with uncontrolled high blood pressure\n* Individuals with sickle cell anemia, current pregnancy\n* Individuals with a history of deep vein thrombosis\n* Individuals with diabetes\n* Individuals with active infection\n* Individuals with less than normal range of motion or muscle strength\n* Individuals with moderate to severe upper extremity injury in the past 12 months\n* Individuals with a current diagnosis of cancer.'}, 'identificationModule': {'nctId': 'NCT05710757', 'briefTitle': 'Investigating Proximal Muscle Strength Effects by Incorporating Proximal Muscle Lengthening', 'organization': {'class': 'OTHER', 'fullName': 'University of Tennessee'}, 'officialTitle': 'Investigating Proximal Muscle Strength Effects by Incorporating Proximal Muscle Lengthening', 'orgStudyIdInfo': {'id': '22-08926-XP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myofascial Release', 'description': 'The Experimental group will receive a myofascial release pectoralis minor release intervention.', 'interventionNames': ['Other: myofascial release', 'Device: blood flow restriction']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Myofascial Release', 'description': 'The Control group will receive a sham myofascial release pectoralis minor release intervention.', 'interventionNames': ['Device: blood flow restriction', 'Other: myofascial release']}], 'interventions': [{'name': 'myofascial release', 'type': 'OTHER', 'description': 'Myofascial release (MFR) is a technique that involves applying gentle sustained pressure into the myofascial connective tissue restrictions to eliminate pain and restore motion.', 'armGroupLabels': ['Myofascial Release']}, {'name': 'blood flow restriction', 'type': 'DEVICE', 'description': 'Blood flow restricted (BFR) exercise is the brief and non-continuous blockage of venous blood flow using a device that restricts the flow of blood while exercising. This technique is used to produce hypertrophy (muscle growth) and strength responses while exercising at a lighter load than traditionally required to produce a similar response.', 'armGroupLabels': ['Myofascial Release', 'Sham Myofascial Release']}, {'name': 'myofascial release', 'type': 'OTHER', 'description': 'Sham MFR.', 'armGroupLabels': ['Sham Myofascial Release']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tennessee', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'LaToya Green', 'investigatorAffiliation': 'University of Tennessee'}}}}