search
Back to results

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

Primary Purpose

Sarcopenia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SRM P31
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcopenia focused on measuring Sarcopenia, Muscle strength, SRM P31, Phosphocreatine

Eligibility Criteria

25 Years - 99 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Old group

Young group

Arm Description

Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.

Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.

Outcomes

Primary Outcome Measures

SRM P31 assessment
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.
SRM P31 assessment
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

T1; tractography and SRM P31 comparison between young and older sedentary adults
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.
T1; tractography and SRM P31 comparison between young and older sedentary adults
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.

Full Information

First Posted
January 7, 2014
Last Updated
July 15, 2019
Sponsor
University Hospital, Toulouse
search

1. Study Identification

Unique Protocol Identification Number
NCT03336294
Brief Title
Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults
Acronym
CAMUS
Official Title
Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Muscle strength, SRM P31, Phosphocreatine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Old group
Arm Type
Other
Arm Description
Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.
Arm Title
Young group
Arm Type
Other
Arm Description
Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.
Intervention Type
Radiation
Intervention Name(s)
SRM P31
Intervention Description
All the volunteers involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.
Primary Outcome Measure Information:
Title
SRM P31 assessment
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.
Time Frame
Change of SRM P31 between Before and during a standardized physical task
Title
SRM P31 assessment
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.
Time Frame
Change of SRM P31 between during and after a standardized physical task
Secondary Outcome Measure Information:
Title
T1; tractography and SRM P31 comparison between young and older sedentary adults
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.
Time Frame
Change between Before and during a standardized physical task
Title
T1; tractography and SRM P31 comparison between young and older sedentary adults
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.
Time Frame
Change between during and after a standardized physical task

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves ROLLAND, MD; PHD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31300
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12890076
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.
Results Reference
background
PubMed Identifier
11273861
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs