Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 7:27 AM
Study NCT ID:
NCT02984332
Status:
COMPLETED
Last Update Posted:
2019-11-08
First Post:
2016-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timecourse of Immobilization Experiment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle size', 'timeFrame': 'Days 0, 2 and 7', 'description': 'Quadriceps muscle volume measured via MRI'}], 'secondaryOutcomes': [{'measure': 'Muscle protein synthesis', 'timeFrame': 'days 0-2, 2-7 and 0-7', 'description': 'The stable isotope tracer deuterium oxide will be used to assess muscle protein synthesis. In conjunction with bilateral vastus lateralis muscle biopsies before and after 2 and 7 days which allow for the calculation of muscle protein synthesis (fractional synthesis rate) between days 0-2, 2-7 and 0-7.'}, {'measure': 'Muscle strength', 'timeFrame': 'Pre and post immobilization', 'description': 'Skeletal muscle one repetition maximum strength was assessed using standard gym equipment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Muscular Atrophy']}, 'descriptionModule': {'briefSummary': 'The effect of unilateral lower limb immobilisation over one week on muscle atrophy', 'detailedDescription': 'This study aims to assess the effect of one week of unilateral leg immobilization on quadriceps muscle volume and muscle protein synthesis rates. Participants wore a leg brace on one leg and ambulated on crutches during the immobilization period. Thirteen healthy young males were recruited to undertake this study.\n\nIt is currently understood that unilateral leg immobilization will result in a reduction in muscle size (Berg et al., 1996, Wall et al., 2015) and muscle protein synthesis rates after a period of disuse (de Boer et al., 2015, Glover et al., 2008). Recent research in this area has shown that even short term periods of leg immobilization (i.e. \\<1 week) will result in reductions in muscle size and muscle protein synthesis rates after the period of disuse (Wall et al., 2015). However we currently do not have detailed information on how muscle disuse affects muscle size and muscle protein synthesis over time during short term disuse (e.g. the first week).\n\nThe stable isotope tracer deuterium oxide (D2O) will be applied to assess cumulative muscle protein synthesis between days 0-2, 2-7 and 0-7 of the immobilization period in both the immobilized and non immobilized legs. This will be in-conjunction with bilateral vastus lateralis muscle biopsies before and after 2 and 7 days of immobilization. Furthremore, quadriceps muscle volume was assessed via MRI scans that again occured before and after 2 and 7 days of immobilization. To gain a mechanistic insight on the molecular changes during disuse a custom designed 48 well Taqman low density microarray genecard was applied to assess the transcriptional response on genes involved in muscle protein synthesis and breakdown.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBMI \\>18 and \\<28 no prescription medications or current illness -\n\nExclusion Criteria:\n\nBMI \\<18 and \\>28 current prescription medication no history of leg injury'}, 'identificationModule': {'nctId': 'NCT02984332', 'acronym': 'TIME', 'briefTitle': 'Timecourse of Immobilization Experiment', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'Short-term Muscle Disuse Induces a Rapid and Sustained Decline in Daily Myofibrillar Protein Synthesis Rates', 'orgStudyIdInfo': {'id': '650061958'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lower limb immobilisation', 'description': 'All participants will undergo 7 days of unilateral leg immobilization. Participants will wear a leg brace (Donjoy X-ACT, DJO Global, USA) on one of their legs which will fix the leg at 40 degrees of flexion for the 7 days. Participants will not be allowed to remove the brace at any stage and are prohibited from bearing weight on the immobilized leg, and will ambulate on crutches throughout the week of immobilization.', 'interventionNames': ['Other: Lower limb immobilisation (leg brace)']}], 'interventions': [{'name': 'Lower limb immobilisation (leg brace)', 'type': 'OTHER', 'armGroupLabels': ['Lower limb immobilisation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EX1 2LU', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Sport & Health Sciences', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}