Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 11:18 AM
Study NCT ID:
NCT03336294
Status:
TERMINATED
Last Update Posted:
2019-07-16
First Post:
2014-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2017-11-05', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SRM P31 assessment', 'timeFrame': 'Change of SRM P31 between Before and during a standardized physical task', 'description': 'Feasibility of a protocol of SRM P31 at rest, during and after a standardized physical task defined by a composite criteria : the rate of valuable variables recorded (\\>90%) inorganic phosphate (iP), phosphocreatine (PCr) and isoform of ATP (alfa, beta, gamma) on the spectre.'}, {'measure': 'SRM P31 assessment', 'timeFrame': 'Change of SRM P31 between during and after a standardized physical task', 'description': 'Feasibility of a protocol of SRM P31 at rest, during and after a standardized physical task defined by a composite criteria : the rate of valuable variables recorded (\\>90%) inorganic phosphate (iP), phosphocreatine (PCr) and isoform of ATP (alfa, beta, gamma) on the spectre.'}], 'secondaryOutcomes': [{'measure': 'T1; tractography and SRM P31 comparison between young and older sedentary adults', 'timeFrame': 'Change between Before and during a standardized physical task', 'description': 'To compare the RMN (T1; tractography and SRM P31) at rest, during and after an exhausting muscle task at 70% 1-RM between young and older sedentary adults.'}, {'measure': 'T1; tractography and SRM P31 comparison between young and older sedentary adults', 'timeFrame': 'Change between during and after a standardized physical task', 'description': 'To compare the RMN (T1; tractography and SRM P31) at rest, during and after an exhausting muscle task at 70% 1-RM between young and older sedentary adults.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'Muscle strength', 'SRM P31', 'Phosphocreatine'], 'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '12890076', 'type': 'BACKGROUND', 'citation': 'Rolland Y, Lauwers-Cances V, Cournot M, Nourhashemi F, Reynish W, Riviere D, Vellas B, Grandjean H. Sarcopenia, calf circumference, and physical function of elderly women: a cross-sectional study. J Am Geriatr Soc. 2003 Aug;51(8):1120-4. doi: 10.1046/j.1532-5415.2003.51362.x.'}, {'pmid': '11273861', 'type': 'BACKGROUND', 'citation': 'Bourdel-Marchasson I, Joseph PA, Dehail P, Biran M, Faux P, Rainfray M, Emeriau JP, Canioni P, Thiaudiere E. Functional and metabolic early changes in calf muscle occurring during nutritional repletion in malnourished elderly patients. Am J Clin Nutr. 2001 Apr;73(4):832-8. doi: 10.1093/ajcn/73.4.832.'}]}, 'descriptionModule': {'briefSummary': 'P31 nuclear magnetic resonance (RMN) Spectroscopy (SRM P31) has currently being poorly used in the field of sarcopenia.\n\nThe aim of the CAMUS study is to investigate the feasibility a protocol of SRM P31 at rest, during and after a standardized physical task. The secondary objective is to compare the metabolism of tyhe skeletal muscle tissue assessed by SRM P31 in young and older individuals. A pilot study, cross-sectional study will be conducted. Ten healthy sedentary 70+ years males and 10 sedentary 25 to 30 years old male will be included.\n\nLevel of physical activity, physical performances, will be assessed at baseline. RMN (T1; tractography and SRM P31) will be performed. SRM P31 will be performed at rest, during and after an exhausting muscle task at 70% 1-RM. Feasibility will be judged on the rate of valuable variables recorded (\\>90%) inorganic phosphate (iP), phosphocreatine (PCr) and isoform of adenosine triphosphate (ATP : alfa, beta, gamma).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Old group : 70+ years males\n* Young group : 25 to 30 years males\n* Sedentary males in the 2 groups\n* Informed consent\n\nExclusion Criteria:\n\n* Contraindication to perform a RMN'}, 'identificationModule': {'nctId': 'NCT03336294', 'acronym': 'CAMUS', 'briefTitle': 'Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults', 'orgStudyIdInfo': {'id': 'RC31/10/159'}, 'secondaryIdInfos': [{'id': '2012-A01506-37', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Old group', 'description': 'Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.', 'interventionNames': ['Radiation: SRM P31']}, {'type': 'OTHER', 'label': 'Young group', 'description': 'Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.', 'interventionNames': ['Radiation: SRM P31']}], 'interventions': [{'name': 'SRM P31', 'type': 'RADIATION', 'description': 'All the volunteers involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.', 'armGroupLabels': ['Old group', 'Young group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Yves ROLLAND, MD; PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}