Stroke, AcuteSARCOSTROKENCT06603701
Sarcopenia in the Acute Stroke
A study testing Bioimpedancemetry and Dynamometry in people with Stroke, Acute, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Regardless of the cause of immobilization, within days or weeks there is rapidly a decrease in strength and muscle mass, which can lead to sarcopenia. In severe strokes, immobilization and neurologic damage may be added to promote sarcopenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Bioimpedancemetry and Dynamometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2024to 6 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute stroke patient
- Over 18 years of age
- Functional Ambulation Categories (FAC) < 3
- NIHSS upper limb score ≥ 1
- Able to understand assessment instructions
- Non-objection to the study
- Affiliated with a social security scheme
Who cannot join
- Person under guardianship or curatorship.
- Person deprived of liberty
- Person under court protection
- Other neurological or rheumatological pathology limiting mobility
- Presence of a pacemaker or defibrillator.
- Pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow up of Strength and Body Composition With Impedancemeter Device During the First 10 Days After Acute Stroke.
Regardless of the cause of immobilization, within days or weeks there is rapidly a decrease in strength and muscle mass, which can lead to sarcopenia. In severe strokes, immobilization and neurologic damage may be added to promote sarcopenia. Several studies in Asian populations confirm rapid increases in sarcopenia rates after stroke, but there are only rare data in Western populations. The aim of this work is to monitor during the first 10 days after a severe stroke leading to a reduction in ambulation, the evolution of muscle strength (studied in dynamometry), body composition (studied by impedance measurement) and sarcopenia rates. Investigators will also look for factors that predict the occurrence of this sarcopenia (such as sex, age, initial deficiency, stroke volume, swallowing disorders, etc.).
Read the detailed description
In stroke patients, muscle damage combines many mechanisms such as immobilization, nutritional disorders , sympathetic activity, inflammation and denervation . These general factors explain that post-stroke sarcopenia is also observed on the side considered healthy .
Several meta-analyzes have been carried out on this subject . In the study by Inoue et al., which brings together 35 studies on the subject, the rates of sarcopenia observed were overall of the order of 15% before the stroke, of 30% in the 10 days post-stroke and of the order of 50% in the first semester . Only about 10 studies have been performed in the acute phase . However, the majority of these studies were performed in Asian populations (32 of them). But this is a population with demographic and physiological characteristics that are different from those in the West. Thus, body mass indices are lower and the representation of older people is higher in the population (the Japanese population is the oldest in the world).
Body composition may be a predictor of the course of recovery from stroke. In a cohort study it was thus shown by bioimpedance measurements that patients with the lowest muscle mass index had more severe neurological deficits at admission. They also had poorer functioning and longer hospital stays. Muscle mass is an independent variable in predicting what happens to people who have had a stroke.
Strokes cause motor deficits that reduce movement on the deficit side but also on the unaffected side. Sarcopenia (loss of strength and muscle mass) develops in the first few days after a stroke and worsens the consequences of neurologic damage. While immobilization rapidly leads to sarcopenia, sarcopenia has been poorly studied in acute stroke, especially in Asian populations, which are unrepresentative of Western populations.
The aims of this work are to:
- Longitudinally determine rates of sarcopenia in the acute phase of stroke during follow-up over the first 10 days after stroke.
- Determine the factors that predict the occurrence of sarcopenia (age, degree of initial deficiency, lesion volume, etc.)
- Track body composition by segment (4 limbs and trunk) over time in impedance measurement, particularly by distinguishing between deficit and nondeficit. Investigators will distinguish the usual parameters (skeletal muscle mass, angle phase).
- Monitor motor recovery of the deficient upper limb and determine whether muscle mass is a prognostic factor for recovery.
Measurement will be done at three time (T1, T2, T3) T1 corresponds to the first 72 hours post stroke T2 corresponds at 5 days (+/-1 days) T2 corresponds at 8 days (+/-1 days)
- Conditions
- Stroke, Acute
- Being tested
- Bioimpedancemetry, Dynamometry
- Keywords
- Stroke, Body composition, Bioimpedancemetry, Sarcopenia
- Medical subject headings
- Stroke, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioimpedancemetryDiagnostic test
- Bioimpedancemetry at T1, T2, T3 ; the measurement will be
- Squeletic mass (total and for each of the 4 limbs)
- Angle phase (total and for each of the 4 limbs)
DynamometryOther
Dynamometry will be performed to assess the strength of each upper limb (deficient and non deficient) at T1, T2, T3
| Study group | Role | What they receive |
|---|---|---|
| Impedance measurement for acute stroke patient | Other | Acute stroke patients will benefit from impedance measurement and dynamometry to determine the evolution of sarcopenia rates. Receives: Diagnostic Test: Bioimpedancemetry; Other: Dynamometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of sarcopenia
The rate of sarcopenia will be defined using the maximum flexion force of the fingers measured on a digital Jamar dynamometer in the healthy upper limb.
Measured: Day 1
rate of sarcopenia
The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry
Measured: Day 1
rate of sarcopenia
The rate of sarcopenia will be defined using the maximum flexion force of the fingers measured on a digital Jamar dynamometer in the healthy upper limb.
Measured: Day 5
rate of sarcopenia
The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry
Measured: Day 5
rate of sarcopenia
The rate of sarcopenia will be defined using the maximum flexion force of the fingers measured on a digital Jamar dynamometer in the healthy upper limb.
Measured: Day 8
rate of sarcopenia
The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry
Measured: Day 8
Secondary outcomes (7)
total skeletal muscle mass and per limb segment
total skeletal muscle mass and per limb segment (expressed in kg)
Measured: Day 5
total skeletal muscle mass and per limb segment
total skeletal muscle mass and per limb segment (expressed in kg)
Measured: Day 8
total angle phase and per limb segment
total angle phase and per limb segment expressed in degrees and evaluated at a frequency of 50kHz
Measured: Day 5
total angle phase and per limb segment
total angle phase and per limb segment expressed in degrees and evaluated at a frequency of 50kHz
Measured: Day 8
Muscular strength of the upper limb deficiency
Muscular strength of the upper limb deficiency expressed in Kg
Measured: Day 1
Muscular strength of the upper limb deficiency
Muscular strength of the upper limb deficiency expressed in Kg
Measured: Day 5
Muscular strength of the upper limb deficiency
Muscular strength of the upper limb deficiency expressed in Kg
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Jun 2024
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Why it stopped: Departure of the principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan OZSANCAK, PH, Principal investigator, CHU Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603701
- Sponsor's protocol ID
- CHUO-2023-10
- Acronym
- SARCOSTROKE
- Status last verified
- Nov 2025
- First submitted
- 16 Aug 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abe T, Iwata K, Yoshimura Y, Shinoda T, Inagaki Y, Ohya S, Yamada K, Oyanagi K, Maekawa Y, Honda A, Kohara N, Tsubaki A. Low Muscle Mass is Associated with Walking Function in Patients with Acute Ischemic Stroke. J Stroke Cerebrovasc Dis. 2020 Nov;29(11):105259. doi: 10.1016/j.jstrokecerebrovasdis.2020.105259. Epub 2020 Aug 28.
PubMed 33066891Herman SD, Friedman AC, Radecki PD, Caroline DF. Incidental prostatic carcinoma detected by MRI and diagnosed by MRI/CT-guided biopsy. AJR Am J Roentgenol. 1986 Feb;146(2):351-2. doi: 10.2214/ajr.146.2.351. No abstract available.
PubMed 3484585Arasaki K, Igarashi O, Ichikawa Y, Machida T, Shirozu I, Hyodo A, Ushijima R. Reduction in the motor unit number estimate (MUNE) after cerebral infarction. J Neurol Sci. 2006 Dec 1;250(1-2):27-32. doi: 10.1016/j.jns.2006.06.024. Epub 2006 Aug 9.
PubMed 16904126Arasaki K, Igarashi O, Machida T, Hyodo A, Ushijima R. Reduction in the motor unit number estimate (MUNE) after cerebral infarction. Suppl Clin Neurophysiol. 2009;60:189-95. doi: 10.1016/s1567-424x(08)00019-6.
PubMed 20715381Beckwee D, Cuypers L, Lefeber N, De Keersmaecker E, Scheys E, Van Hees W, Perkisas S, De Raedt S, Kerckhofs E, Bautmans I, Swinnen E. Skeletal Muscle Changes in the First Three Months of Stroke Recovery: A Systematic Review. J Rehabil Med. 2022 Oct 4;54:jrm00308. doi: 10.2340/jrm.v54.573.
PubMed 35848335Bellelli G, Zambon A, Volpato S, Abete P, Bianchi L, Bo M, Cherubini A, Corica F, Di Bari M, Maggio M, Manca GM, Rizzo MR, Rossi A, Landi F; GLISTEN Group Investigators. The association between delirium and sarcopenia in older adult patients admitted to acute geriatrics units: Results from the GLISTEN multicenter observational study. Clin Nutr. 2018 Oct;37(5):1498-1504. doi: 10.1016/j.clnu.2017.08.027. Epub 2017 Sep 5.
PubMed 28918171Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed Definitions and a Shared Vision for New Standards in Stroke Recovery Research: The Stroke Recovery and Rehabilitation Roundtable Taskforce. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.
PubMed 28934920
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Strength and Body Composition With Impedancemeter Device During the First 10 Days After Acute Stroke.
- ClinicalTrials.gov ID
- NCT06603701
- Acronym / sponsor ID
- SARCOSTROKE / CHUO-2023-10
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Body composition, Bioimpedancemetry, Sarcopenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of the principal investigator
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (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.
Regardless of the cause of immobilization, within days or weeks there is rapidly a decrease in strength and muscle mass, which can lead to sarcopenia. In severe strokes, immobilization and neurologic damage may be added to promote sarcopenia. Several studies in Asian populations confirm rapid increases in sarcopenia rates after stroke, but there are only rare data in Western populations. The aim of this work is to monitor during the first 10 days after a severe stroke leading to a reduction in ambulation, the evolution of muscle strength (studied in dynamometry), body composition (studied by impedance measurement) and sarcopenia rates. Investigators will also look for factors that predict the occurrence of this sarcopenia (such as sex, age, initial deficiency, stroke volume, swallowing disorders, etc.).
Detailed description
In stroke patients, muscle damage combines many mechanisms such as immobilization, nutritional disorders , sympathetic activity, inflammation and denervation . These general factors explain that post-stroke sarcopenia is also observed on the side considered healthy .
Several meta-analyzes have been carried out on this subject . In the study by Inoue et al., which brings together 35 studies on the subject, the rates of sarcopenia observed were overall of the order of 15% before the stroke, of 30% in the 10 days post-stroke and of the order of 50% in the first semester . Only about 10 studies have been performed in the acute phase . However, the majority of these studies were performed in Asian populations (32 of them). But this is a population with demographic and physiological characteristics that are different from those in the West. Thus, body mass indices are lower and the representation of older people is higher in the population (the Japanese population is the oldest in the world).
Body composition may be a predictor of the course of recovery from stroke. In a cohort study it was thus shown by bioimpedance measurements that patients with the lowest muscle mass index had more severe neurological deficits at admission. They also had poorer functioning and longer hospital stays. Muscle mass is an independent variable in predicting what happens to people who have had a stroke.
Strokes cause motor deficits that reduce movement on the deficit side but also on the unaffected side. Sarcopenia (loss of strength and muscle mass) develops in the first few days after a stroke and worsens the consequences of neurologic damage. While immobilization rapidly leads to sarcopenia, sarcopenia has been poorly studied in acute stroke, especially in Asian populations, which are unrepresentative of Western populations.
The aims of this work are to:
- Longitudinally determine rates of sarcopenia in the acute phase of stroke during follow-up over the first 10 days after stroke.
- Determine the factors that predict the occurrence of sarcopenia (age, degree of initial deficiency, lesion volume, etc.)
- Track body composition by segment (4 limbs and trunk) over time in impedance measurement, particularly by distinguishing between deficit and nondeficit. Investigators will distinguish the usual parameters (skeletal muscle mass, angle phase).
- Monitor motor recovery of the deficient upper limb and determine whether muscle mass is a prognostic factor for recovery.
Measurement will be done at three time (T1, T2, T3) T1 corresponds to the first 72 hours post stroke T2 corresponds at 5 days (+/-1 days) T2 corresponds at 8 days (+/-1 days)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impedance measurement for acute stroke patient | Other | Diagnostic Test: Bioimpedancemetry, Other: DynamometryAcute stroke patients will benefit from impedance measurement and dynamometry to determine the evolution of sarcopenia rates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute stroke patient
- Over 18 years of age
- Functional Ambulation Categories (FAC) < 3
- NIHSS upper limb score ≥ 1
- Able to understand assessment instructions
Key exclusion criteria (6 listed)
- Person under guardianship or curatorship.
- Person deprived of liberty
- Person under court protection
- Other neurological or rheumatological pathology limiting mobility
- Presence of a pacemaker or defibrillator.
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 |
|---|---|---|
| Bioimpedancemetry2. Bioimpedancemetry at T1, T2, T3 ; the measurement will be 1. Squeletic mass (total and for each of the 4 limbs) 2. Angle phase (total and for each of the 4 limbs) | Diagnostic test | Impedance measurement for acute stroke patient |
| DynamometryDynamometry will be performed to assess the strength of each upper limb (deficient and non deficient) at T1, T2, T3 | Other | Impedance measurement for acute stroke patient |
Primary outcome
rate of sarcopenia
Time frame: Day 1
The rate of sarcopenia will be defined using the maximum flexion force of the fingers measured on a digital Jamar dynamometer in the healthy upper limb.
rate of sarcopenia
Time frame: Day 1
The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry
rate of sarcopenia
Time frame: Day 5
The rate of sarcopenia will be defined using the maximum flexion force of the fingers measured on a digital Jamar dynamometer in the healthy upper limb.
rate of sarcopenia
Time frame: Day 5
The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry
rate of sarcopenia
Time frame: Day 8
The rate of sarcopenia will be defined using the maximum flexion force of the fingers measured on a digital Jamar dynamometer in the healthy upper limb.
rate of sarcopenia
Time frame: Day 8
The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry
7 secondary outcomes
total skeletal muscle mass and per limb segment
Time frame: Day 5
total skeletal muscle mass and per limb segment
Time frame: Day 8
total angle phase and per limb segment
Time frame: Day 5
total angle phase and per limb segment
Time frame: Day 8
Muscular strength of the upper limb deficiency
Time frame: Day 1
Muscular strength of the upper limb deficiency
Time frame: Day 5
Muscular strength of the upper limb deficiency
Time frame: Day 8
Results and safety
The study was stopped early (reason given: Departure of the principal investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 33066891Abe T, Iwata K, Yoshimura Y, Shinoda T, Inagaki Y, Ohya S, Yamada K, Oyanagi K, Maekawa Y, Honda A, Kohara N, Tsubaki A. Low Muscle Mass is Associated with Walking Function in Patients with Acute Ischemic Stroke. J Stroke Cerebrovasc Dis. 2020 Nov;29(11):105259. doi: 10.1016/j.jstrokecerebrovasdis.2020.105259. Epub 2020 Aug 28.
- Background: PubMed 3484585Herman SD, Friedman AC, Radecki PD, Caroline DF. Incidental prostatic carcinoma detected by MRI and diagnosed by MRI/CT-guided biopsy. AJR Am J Roentgenol. 1986 Feb;146(2):351-2. doi: 10.2214/ajr.146.2.351. No abstract available.
- Background: PubMed 16904126Arasaki K, Igarashi O, Ichikawa Y, Machida T, Shirozu I, Hyodo A, Ushijima R. Reduction in the motor unit number estimate (MUNE) after cerebral infarction. J Neurol Sci. 2006 Dec 1;250(1-2):27-32. doi: 10.1016/j.jns.2006.06.024. Epub 2006 Aug 9.
- Background: PubMed 20715381Arasaki K, Igarashi O, Machida T, Hyodo A, Ushijima R. Reduction in the motor unit number estimate (MUNE) after cerebral infarction. Suppl Clin Neurophysiol. 2009;60:189-95. doi: 10.1016/s1567-424x(08)00019-6.
- Background: PubMed 35848335Beckwee D, Cuypers L, Lefeber N, De Keersmaecker E, Scheys E, Van Hees W, Perkisas S, De Raedt S, Kerckhofs E, Bautmans I, Swinnen E. Skeletal Muscle Changes in the First Three Months of Stroke Recovery: A Systematic Review. J Rehabil Med. 2022 Oct 4;54:jrm00308. doi: 10.2340/jrm.v54.573.
- Background: PubMed 28918171Bellelli G, Zambon A, Volpato S, Abete P, Bianchi L, Bo M, Cherubini A, Corica F, Di Bari M, Maggio M, Manca GM, Rizzo MR, Rossi A, Landi F; GLISTEN Group Investigators. The association between delirium and sarcopenia in older adult patients admitted to acute geriatrics units: Results from the GLISTEN multicenter observational study. Clin Nutr. 2018 Oct;37(5):1498-1504. doi: 10.1016/j.clnu.2017.08.027. Epub 2017 Sep 5.
- Background: PubMed 28934920Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed Definitions and a Shared Vision for New Standards in Stroke Recovery Research: The Stroke Recovery and Rehabilitation Roundtable Taskforce. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.
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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.
Canan OZSANCAK, PH principal investigator
CHU Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioimpedancemetry and Dynamometry in people with Stroke, Acute, run by Centre Hospitalier Régional d'Orléans 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 7 inclusion and 6 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 4 Dec 2025. 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 (reason given: Departure of the principal investigator). 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?
rate of sarcopenia (time frame: Day 1). The study lists 6 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 NCT06603701, which also lists 7 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 4 Dec 2025.