- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06603701
Sarcopenia in the Acute Stroke (SARCOSTROKE)
Follow up of Strength and Body Composition With Impedancemeter Device During the First 10 Days After Acute Stroke.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Orléans, France, 45067
- CHU d'Orléans
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Impedance measurement for acute stroke patient
Acute stroke patients will benefit from impedance measurement and dynamometry to determine the evolution of sarcopenia rates.
|
2. Bioimpedancemetry at T1, T2, T3 ; the measurement will be
Dynamometry will be performed to assess the strength of each upper limb (deficient and non deficient) at T1, T2, T3
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day 1
|
|
rate of sarcopenia
Time Frame: Day 1
|
The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry
|
Day 1
|
|
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.
|
Day 5
|
|
rate of sarcopenia
Time Frame: Day 5
|
The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry
|
Day 5
|
|
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.
|
Day 8
|
|
rate of sarcopenia
Time Frame: Day 8
|
The rate of sarcopenia will be define using appendicular muscle mass index (Kg/m2) measured by impedancemetry
|
Day 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total skeletal muscle mass and per limb segment
Time Frame: Day 5
|
total skeletal muscle mass and per limb segment (expressed in kg)
|
Day 5
|
|
total skeletal muscle mass and per limb segment
Time Frame: Day 8
|
total skeletal muscle mass and per limb segment (expressed in kg)
|
Day 8
|
|
total angle phase and per limb segment
Time Frame: Day 5
|
total angle phase and per limb segment expressed in degrees and evaluated at a frequency of 50kHz
|
Day 5
|
|
total angle phase and per limb segment
Time Frame: Day 8
|
total angle phase and per limb segment expressed in degrees and evaluated at a frequency of 50kHz
|
Day 8
|
|
Muscular strength of the upper limb deficiency
Time Frame: Day 1
|
Muscular strength of the upper limb deficiency expressed in Kg
|
Day 1
|
|
Muscular strength of the upper limb deficiency
Time Frame: Day 5
|
Muscular strength of the upper limb deficiency expressed in Kg
|
Day 5
|
|
Muscular strength of the upper limb deficiency
Time Frame: Day 8
|
Muscular strength of the upper limb deficiency expressed in Kg
|
Day 8
|
Collaborators and Investigators
Investigators
- Principal Investigator: Canan OZSANCAK, PH, CHU Orléans
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Sarcopenia
Other Study ID Numbers
- CHUO-2023-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke, Acute
-
University Hospital HeidelbergCompletedAcute Ischemic Stroke | Acute Ischemic Stroke AIS | Acute Ischemic Stroke PatientsGermany
-
Capital Medical UniversityCompletedAcute Ischaemic Stroke | Stroke-associated PneumoniaChina
-
University of CalgaryThe George Institute for Global Health, AustraliaRecruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Chinese University of Hong KongThe Hong Kong Polytechnic University; City University of Hong Kong; Hong Kong... and other collaboratorsRecruitingAcute Ischemic Stroke | Acute Stroke | Acute Stroke InterventionHong Kong
-
Prof. Dr. Jan LimanUniversity Hospital, Basel, Switzerland; Klinikum Nürnberg; Deutsche ForschungegemeinschaftRecruitingHemorrhagic Stroke, Intracerebral | Acute Ischemic Stroke AIS | Stroke AcuteSwitzerland, Germany
-
University of MiamiNo longer availableStroke, Ischemic | Stroke, Acute | Mesenchymal Stem Cells | Acute Ischemic Stroke | Stroke/Brain AttackUnited States
-
Cidat, S.A. de C.V.El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUnknownStroke | Stroke, Acute | Cerebral Stroke | Cerebrovascular Stroke | Cerebrovascular Accident, AcuteMexico
-
Hospital Universitari Vall d'Hebron Research InstituteMethinks Software SLRecruitingStroke | Ischemic Stroke, Acute | Thrombectomy | Stroke AcuteSpain
-
NeurotechnikaSamara State Medical University; Samara Regional Clinical Hospital V.D. SeredavinRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Acute | Stroke, Acute, Ischemic | Stroke with HemiparesisRussian Federation
-
Southwest Hospital, ChinaRecruitingAcute Ischemic Stroke PatientsChina
Clinical Trials on Bioimpedancemetry
-
Esther SolerNot yet recruitingDiabetes Mellitus | Diabetic Foot | Metabolic Syndrome | Sarcopenia | Neuropathy, Diabetic | Vascular Disease, Peripheral