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Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults (CAMUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03336294
Recruitment Status : Terminated
First Posted : November 8, 2017
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

P31 nuclear magnetic resonance (RMN) Spectroscopy (SRM P31) has currently being poorly used in the field of sarcopenia.

The 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.

Level 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).


Condition or disease Intervention/treatment Phase
Sarcopenia Radiation: SRM P31 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Old group
Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.
Radiation: SRM P31
All the volunteers involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.

Young group
Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.
Radiation: SRM P31
All the volunteers involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.




Primary Outcome Measures :
  1. SRM P31 assessment [ Time Frame: Change of SRM P31 between Before and during a standardized physical task ]
    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.

  2. SRM P31 assessment [ Time Frame: Change of SRM P31 between during and after a standardized physical task ]
    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.


Secondary Outcome Measures :
  1. T1; tractography and SRM P31 comparison between young and older sedentary adults [ Time Frame: Change between Before and during a standardized physical task ]
    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.

  2. T1; tractography and SRM P31 comparison between young and older sedentary adults [ Time Frame: Change between during and after a standardized physical task ]
    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.



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Ages Eligible for Study:   25 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Old group : 70+ years males
  • Young group : 25 to 30 years males
  • Sedentary males in the 2 groups
  • Informed consent

Exclusion Criteria:

  • Contraindication to perform a RMN

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336294


Locations
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France
University Hospital Toulouse
Toulouse, France, 31300
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Yves ROLLAND, MD; PHD University Hospital, Toulouse
Publications:
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03336294    
Other Study ID Numbers: RC31/10/159
2012-A01506-37 ( Other Identifier: ID-RCB )
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Sarcopenia
Muscle strength
SRM P31
Phosphocreatine
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms