SarcopeniaCAMUSNCT03336294
Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults
A study testing SRM P31 in people with Sarcopenia, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- SRM P31
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2013to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Old group : 70+ years males
- Young group : 25 to 30 years males
- Sedentary males in the 2 groups
- Informed consent
Who cannot join
- Contraindication to perform a RMN
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Sarcopenia
- Being tested
- SRM P31
- Keywords
- Sarcopenia, Muscle strength, SRM P31, Phosphocreatine
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRM P31Radiation
All the volunteers involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.
| Study group | Role | What they receive |
|---|---|---|
| Old group | Other | Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM. Receives: Radiation: SRM P31 |
| Young group | Other | Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM. Receives: Radiation: SRM P31 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change of SRM P31 between Before and during a standardized physical task
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.
Measured: Change of SRM P31 between during and after a standardized physical task
Secondary outcomes (2)
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.
Measured: Change between Before and during a standardized physical task
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.
Measured: Change between during and after a standardized physical task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Apr 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves ROLLAND, MD; PHD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336294
- Sponsor's protocol ID
- RC31/10/159
- Other IDs
- 2012-A01506-37
- Acronym
- CAMUS
- Status last verified
- Jul 2019
- First submitted
- 7 Jan 2014
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12890076Bourdel-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.
PubMed 11273861
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults
- ClinicalTrials.gov ID
- NCT03336294
- Acronym / sponsor ID
- CAMUS / RC31/10/159
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Muscle strength, SRM P31, Phosphocreatine
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Old group | Other | Radiation: SRM P31Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM. |
| Young group | Other | Radiation: SRM P31Subjects involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM. |
Who may qualify
- Ages
- 25 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Old group : 70+ years males
- Young group : 25 to 30 years males
- Sedentary males in the 2 groups
- Informed consent
Key exclusion criteria (1 listed)
- Contraindication to perform a RMN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRM P31All the volunteers involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM. | Radiation | Old group, Young group |
Primary outcome
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.
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.
2 secondary outcomes
T1; tractography and SRM P31 comparison between young and older sedentary adults
Time frame: Change between Before and during a standardized physical task
T1; tractography and SRM P31 comparison between young and older sedentary adults
Time frame: Change between during and after a standardized physical task
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 12890076Rolland 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.
- Background: PubMed 11273861Bourdel-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves ROLLAND, MD; PHD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRM P31 in people with Sarcopenia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SRM P31 assessment (time frame: Change of SRM P31 between Before and during a standardized physical task). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03336294, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.