Sarcopenia in the Acute Stroke

NCT ID: NCT06603701

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-28

Study Completion Date

2024-08-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. Longitudinally determine rates of sarcopenia in the acute phase of stroke during follow-up over the first 10 days after stroke.
2. Determine the factors that predict the occurrence of sarcopenia (age, degree of initial deficiency, lesion volume, etc.)
3. 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).
4. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Acute

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Impedance measurement for acute stroke patient

Acute stroke patients will benefit from impedance measurement and dynamometry to determine the evolution of sarcopenia rates.

Group Type OTHER

Bioimpedancemetry

Intervention Type DIAGNOSTIC_TEST

2\. 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)

Dynamometry

Intervention Type OTHER

Dynamometry will be performed to assess the strength of each upper limb (deficient and non deficient) at T1, T2, T3

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bioimpedancemetry

2\. 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)

Intervention Type DIAGNOSTIC_TEST

Dynamometry

Dynamometry will be performed to assess the strength of each upper limb (deficient and non deficient) at T1, T2, T3

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Canan OZSANCAK, PH

Role: PRINCIPAL_INVESTIGATOR

CHU Orléans

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU d'ORLEANS

Orléans, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33066891 (View on PubMed)

Herman 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.

Reference Type BACKGROUND
PMID: 3484585 (View on PubMed)

Arasaki 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.

Reference Type BACKGROUND
PMID: 16904126 (View on PubMed)

Arasaki 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.

Reference Type BACKGROUND
PMID: 20715381 (View on PubMed)

Beckwee 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.

Reference Type BACKGROUND
PMID: 35848335 (View on PubMed)

Bellelli 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.

Reference Type BACKGROUND
PMID: 28918171 (View on PubMed)

Bernhardt 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.

Reference Type BACKGROUND
PMID: 28934920 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHUO-2023-10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.