Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-26 @ 6:08 AM
Study NCT ID:
NCT05097092
Status:
UNKNOWN
Last Update Posted:
2021-10-27
First Post:
2021-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strength Training Augmenting Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-08-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2021-09-22', 'studyFirstSubmitQcDate': '2021-10-14', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in isometric muscle strength', 'timeFrame': 'Changes from baseline at 5 and 10 weeks', 'description': 'MVC (Newton)'}, {'measure': 'Changes in dynamic muscle strength', 'timeFrame': 'Changes from baseline at 5 and 10 weeks', 'description': '1RM (lbs)'}, {'measure': 'Changes in muscle size', 'timeFrame': 'Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks', 'description': 'Ultrasound muscle thickness of biceps brachii and triceps brachii'}, {'measure': 'Changes in lean mass', 'timeFrame': 'Changes from baseline at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 weeks', 'description': 'DEXA'}, {'measure': 'Changes in EMG amplitude', 'timeFrame': 'Changes from baseline at 5 and 10 weeks', 'description': 'Surface EMG'}, {'measure': 'Changes in action potential amplitude', 'timeFrame': 'Changes from baseline at 5 and 10 weeks', 'description': 'Surface EMG Decomposition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Disuse Atrophy']}, 'descriptionModule': {'briefSummary': 'This project aims to determine whether a novel strength training rehabilitation protocol can diminish the negative consequences of limb immobilization and expedite the restoration of muscle function during retraining in healthy individuals.', 'detailedDescription': 'The present study will examine the time course of muscle strength and size adaptations in two groups of volunteers during immobilization and retraining. Both groups will undergo temporary muscle disuse by wearing a shoulder sling and swathe on their non-dominant arm for \\~≥10 hours/day for four weeks. One group (immobilization + unilateral training) will perform progressive unilateral strength training of the free limb throughout the immobilization period. The other group (immobilization control) will not undergo any training during the immobilization period. Following immobilization, both groups will undergo four weeks of bilateral strength training to retrain the immobilized arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a body mass index between 18 - 35 kg/m2\n* 18-35 years of age\n* right-hand dominant\n* willingness to comply with the immobilization requirements\n* willingness to refrain from strength training outside of the study\n* willingness to comply with the strength training procedures of the study\n\nExclusion Criteria:\n\n* a personal or family history of blood clots\n* a personal or family history of thyroid disorders\n* previous orthopedic surgeries to the upper limbs and/or joint pain of the upper limbs in the last 6 months\n* neuromuscular or metabolic disorders\n* osteoarthritis\n* use of hormone replacement therapy (ie., testosterone, estrogen, and/or growth hormone pharmaceuticals)\n* pregnancy and/or nursing'}, 'identificationModule': {'nctId': 'NCT05097092', 'acronym': 'STAR', 'briefTitle': 'Strength Training Augmenting Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Texas Christian University'}, 'officialTitle': 'Strength Training Augmenting Rehabilitation - 1', 'orgStudyIdInfo': {'id': '2021-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immobilization control', 'description': 'The immobilization control group will undergo arm immobilization. Immobilization will be implemented with four weeks of muscle unloading with a sling and swathe on the nondominant arm. The sling will suspend the arm at the elbow joint with the elbow in a flexed position at 90°, the swathe will then wrap around the participant to fix the arm against the body.', 'interventionNames': ['Procedure: Orthopedic immobilization', 'Other: Bilateral resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'Immobilization with unilateral training', 'description': 'The immobilization with unilateral training group will undergo arm immobilization for four with a sling and swathe on the nondominant arm. The sling will suspend the arm at the elbow joint with the elbow in a flexed position at 90°, the swathe will then wrap around the participant to fix the arm against the body. The free (non-immobilzed) arm of this group will undergo heavy strength training twice per week throughout the immobilization period. The training will consist of unilateral dumbbell shoulder press and biceps curl.', 'interventionNames': ['Procedure: Orthopedic immobilization', 'Other: Unilateral resistance training', 'Other: Bilateral resistance training']}], 'interventions': [{'name': 'Orthopedic immobilization', 'type': 'PROCEDURE', 'description': 'Orthopedic immobilization will be performed with a sling and swathe.', 'armGroupLabels': ['Immobilization control', 'Immobilization with unilateral training']}, {'name': 'Unilateral resistance training', 'type': 'OTHER', 'description': 'Unilateral resistance training will be performed by the dominant arm of the immobilization + unilateral resistance training group during Phase 1.', 'armGroupLabels': ['Immobilization with unilateral training']}, {'name': 'Bilateral resistance training', 'type': 'OTHER', 'description': 'Bilateral resistance training will be performed by both arms in both groups during Phase 2.', 'armGroupLabels': ['Immobilization control', 'Immobilization with unilateral training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76126', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'TCU Neuromuscular Physiology Laboratory', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '76126', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joshua C Carr', 'role': 'CONTACT', 'email': 'joshua.carr@tcu.edu', 'phone': '917-257-6867'}], 'facility': 'TCU RIC', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Christian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Joshua Carr', 'investigatorAffiliation': 'Texas Christian University'}}}}