Sarcopenia in the Acute Stroke

NCT06603701 | Terminated

• 1 other identifier: CHUO-2023-10
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.).

Conditions

Stroke, Acute

Keywords

Stroke; Body composition; Bioimpedancemetry; Sarcopenia

Outcome Measures

Primary Outcomes (6)

• 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.

  Day 1

• rate of sarcopenia

  The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry

  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.

  Day 5

• rate of sarcopenia

  The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry

  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.

  Day 8

• rate of sarcopenia

  The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry

  Day 8

Secondary Outcomes (7)

• total skeletal muscle mass and per limb segment

  Day 5

• total skeletal muscle mass and per limb segment

  Day 8

• total angle phase and per limb segment

  Day 5

• total angle phase and per limb segment

  Day 8

• Muscular strength of the upper limb deficiency

  Day 1

Study Arms (1)

Impedance measurement for acute stroke patient

OTHER

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

Diagnostic Test: Bioimpedancemetry; Other: Dynamometry

Interventions

Bioimpedancemetry 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)

Impedance measurement for acute stroke patient

Dynamometry OTHER

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

Impedance measurement for acute stroke patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHU d'ORLEANS

Orléans, 45067, France

Location

Related Publications (7)

• 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.

  PMID: 33066891 BACKGROUND

• 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.

  PMID: 3484585 BACKGROUND

• 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.

  PMID: 16904126 BACKGROUND

• 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.

  PMID: 20715381 BACKGROUND

• 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.

  PMID: 35848335 BACKGROUND

• 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.

  PMID: 28918171 BACKGROUND

• 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.

  PMID: 28934920 BACKGROUND

MeSH Terms

Conditions

Stroke; Sarcopenia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Canan OZSANCAK, PH

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: September 19, 2024
• Study Start: June 28, 2024
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

FR (1)