SarcopeniaSPAMNCT05199207
Sarcopenia Physical Activity and Metabolomic
A study testing Physical activity programm in people with Sarcopenia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Muscle failure (sarcopenia or dynapenia) is a factor of frailty and therefore, ultimately, of loss of autonomy in the elderly. Currently, no biomarker of muscle failure has a high sensitivity, specificity and positive predictive value. Read more about this study
- Who is it for?
- Ages 65 months and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Physical activity programm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2022to 5 Jul 2022
- 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 65 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 65 years;
- Patient affiliated or beneficiary of a social security plan;
- Patient having signed a prior informed consent
Who cannot join
- presence of a physical or cognitive pathology preventing the performance of the physical activity protocol during 3 months
- Patient with legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Muscle failure (sarcopenia or dynapenia) is a factor of frailty and therefore, ultimately, of loss of autonomy in the elderly. Currently, no biomarker of muscle failure has a high sensitivity, specificity and positive predictive value. Several results, although preliminary, suggest that metabolomics could facilitate the early identification of frail patients, allowing the implementation of primary prevention strategies. Untargeted high-resolution metabolomics analysis would identify discriminative biomarkers and biological mechanisms associated with frailty. Finally, the hypothesis that metabolic signatures can be identified as risk factors for the development of age-related dynapenia should be tested in a longitudinal design.
Read the detailed description
Sarcopenia is defined as decreased muscle strength and low muscle quantity or quality. Screening and management of sarcopenia was modified in early 2019 by the European Working Group on Sarcopenia in Older People (EWGSOP) with the creation of the F-A-C-S (Find-Assess-Confirm-Severity) protocol. The search for sarcopenia (Find) is done during the interrogation of the patient expressing symptoms that may be related to the loss of muscle mass, such as falls, asthenia, weight loss, decreased walking speed, or difficulty getting up from a chair. A simple self-report questionnaire (SARC-F) has been created to facilitate screening. Clinical suspicion of sarcopenia requires the performance of a functional assessment (Assess), using for example grip strength.and the chair lift test to look for decreased muscle strength. A pathological result already allows the suspicion of sarcopenia and the introduction of secondary prophylactic measures. Diagnostic confirmation of sarcopenia (Confirm) can be obtained by demonstrating a decrease in muscle mass by one of four validated techniques: magnetic resonance imaging (MRI), computed tomography (CT), dual-energy X-ray absorptiometry (DXA) (Buckinx et al., 2018), or bioimpedancemetry (Rossi et al., 2014). Sarcopenia is considered severe (Severity) if there is a decrease in overall physical performance objectified by physical tests such as the Time Up and Go Test, walking speed, or the Short Physical Performance Battery (SPPB) test.
The development and validation of a single biomarker could be a simple and cost-effective way to diagnose and monitor individuals with sarcopenia. Potential biomarkers could include markers of neuromuscular junction, muscle protein turnover, behaviorally mediated pathways, inflammation-mediated pathways, redox-related factors, and hormones or other anabolic factors (Curcio et al., 2016). However, due to the complex pathophysiology of sarcopenia, it is unlikely that a single biomarker can identify the disease in the heterogeneous population of young and old. Instead, the development of a panel of biomarkers should be considered, including potential serum markers and tissue markers. Implementing a multidimensional methodology for modeling these pathways could provide a means to stratify risk for sarcopenia, facilitate identification of worsening of the condition, and track treatment efficacy.
In the context of physical frailty and sarcopenia, the study of dynamic metabolic responses to stressors and the characterization of the biochemical pathways involved are particularly relevant, as this condition is closely associated with metabolic disorders. Disturbances in protein and amino acid metabolism may contribute substantially to the pathophysiology of sarcopenia.
The hypothesis that metabolic signatures can be identified as risk factors for the development of age-related sarcopenia needs to be tested in a longitudinal design.
The main objective is to Identify metabolomic signatures of muscle failure in the elderly.
- Conditions
- Sarcopenia
- Being tested
- Physical activity programm
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programmBehavioural
adapted physical activity during 3 month
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic patient | Experimental | Patient with sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value) Receives: Behavioral: Physical activity programm |
| Non sarcopenic patient | Active comparator | Patient without sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value) Receives: Behavioral: Physical activity programm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Different metabolomic signature (The amino acid composition) between the sarcopenic group and the control group
Change in the amino acid composition (metabolomic signature) at Day 0 between the sarcopenic group and the control group
Measured: at Day 0
Secondary outcomes (1)
Change in the amino acid composition (metabolomic signature) after 3 month of physical activity
Change in the amino acid composition (metabolomic signature) after 3 month of physical activity for the sarcopenic group compared to the control group
Measured: between Day 0 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start11 Jan 2022
- Primary completion22 Apr 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emeline MICHEL, MD, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199207
- Sponsor's protocol ID
- 20-AOI-11
- Acronym
- SPAM
- Status last verified
- Jul 2022
- First submitted
- 16 Dec 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia Physical Activity and Metabolomic
- ClinicalTrials.gov ID
- NCT05199207
- Acronym / sponsor ID
- SPAM / 20-AOI-11
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 20 Jan 2022 (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.
Muscle failure (sarcopenia or dynapenia) is a factor of frailty and therefore, ultimately, of loss of autonomy in the elderly. Currently, no biomarker of muscle failure has a high sensitivity, specificity and positive predictive value. Several results, although preliminary, suggest that metabolomics could facilitate the early identification of frail patients, allowing the implementation of primary prevention strategies. Untargeted high-resolution metabolomics analysis would identify discriminative biomarkers and biological mechanisms associated with frailty. Finally, the hypothesis that metabolic signatures can be identified as risk factors for the development of age-related dynapenia should be tested in a longitudinal design.
Detailed description
Sarcopenia is defined as decreased muscle strength and low muscle quantity or quality. Screening and management of sarcopenia was modified in early 2019 by the European Working Group on Sarcopenia in Older People (EWGSOP) with the creation of the F-A-C-S (Find-Assess-Confirm-Severity) protocol. The search for sarcopenia (Find) is done during the interrogation of the patient expressing symptoms that may be related to the loss of muscle mass, such as falls, asthenia, weight loss, decreased walking speed, or difficulty getting up from a chair. A simple self-report questionnaire (SARC-F) has been created to facilitate screening. Clinical suspicion of sarcopenia requires the performance of a functional assessment (Assess), using for example grip strength.and the chair lift test to look for decreased muscle strength. A pathological result already allows the suspicion of sarcopenia and the introduction of secondary prophylactic measures. Diagnostic confirmation of sarcopenia (Confirm) can be obtained by demonstrating a decrease in muscle mass by one of four validated techniques: magnetic resonance imaging (MRI), computed tomography (CT), dual-energy X-ray absorptiometry (DXA) (Buckinx et al., 2018), or bioimpedancemetry (Rossi et al., 2014). Sarcopenia is considered severe (Severity) if there is a decrease in overall physical performance objectified by physical tests such as the Time Up and Go Test, walking speed, or the Short Physical Performance Battery (SPPB) test.
The development and validation of a single biomarker could be a simple and cost-effective way to diagnose and monitor individuals with sarcopenia. Potential biomarkers could include markers of neuromuscular junction, muscle protein turnover, behaviorally mediated pathways, inflammation-mediated pathways, redox-related factors, and hormones or other anabolic factors (Curcio et al., 2016). However, due to the complex pathophysiology of sarcopenia, it is unlikely that a single biomarker can identify the disease in the heterogeneous population of young and old. Instead, the development of a panel of biomarkers should be considered, including potential serum markers and tissue markers. Implementing a multidimensional methodology for modeling these pathways could provide a means to stratify risk for sarcopenia, facilitate identification of worsening of the condition, and track treatment efficacy.
In the context of physical frailty and sarcopenia, the study of dynamic metabolic responses to stressors and the characterization of the biochemical pathways involved are particularly relevant, as this condition is closely associated with metabolic disorders. Disturbances in protein and amino acid metabolism may contribute substantially to the pathophysiology of sarcopenia.
The hypothesis that metabolic signatures can be identified as risk factors for the development of age-related sarcopenia needs to be tested in a longitudinal design.
The main objective is to Identify metabolomic signatures of muscle failure in the elderly.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic patient | Experimental | Behavioral: Physical activity programmPatient with sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value) |
| Non sarcopenic patient | Active comparator | Behavioral: Physical activity programmPatient without sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value) |
Who may qualify
- Ages
- 65 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 65 years;
- Patient affiliated or beneficiary of a social security plan;
- Patient having signed a prior informed consent
Key exclusion criteria (2 listed)
- presence of a physical or cognitive pathology preventing the performance of the physical activity protocol during 3 months
- Patient with legal protection
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 |
|---|---|---|
| Physical activity programmadapted physical activity during 3 month | Behavioural | Non sarcopenic patient, Sarcopenic patient |
Primary outcome
Different metabolomic signature (The amino acid composition) between the sarcopenic group and the control group
Time frame: at Day 0
Change in the amino acid composition (metabolomic signature) at Day 0 between the sarcopenic group and the control group
1 secondary outcome
Change in the amino acid composition (metabolomic signature) after 3 month of physical activity
Time frame: between Day 0 and Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Not yet recruitingObservational study
Sarcopenia Risk in Obese T2DM Patients
Sarcopenia, Obesity Type 2 Diabetes Mellitus
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
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.
Emeline MICHEL, MD principal investigator
Nice University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity programm in people with Sarcopenia, run by Centre Hospitalier Universitaire de Nice 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jul 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Different metabolomic signature (The amino acid composition) between the sarcopenic group and the control group (time frame: at Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2022.