Body Composition and Acute Stroke

Официальное название

Prognostic Value for Predicting Functional Outcome Bioimpedancemetry and Temporal Muscle Measurement in Acute Stroke

Обзор

Body composition appears to be a prognostic factor for the severity and functional outcome of stroke patients. In this study the prognostic value of two bioimpedance parameters will be studied (skeletal mass index and phase angle) and two temporal muscle measurements (thickness and surface area) to predict the functional outcome of patients at discharge and at 6 months

Подробное описание

A stroke commonly causes weakness and loss of independence. Predicting functional outcomes is a major challenge because it guides rehabilitation care or institutionalization choices. Various factors, including the extent of the initial deficit or the size of the lesion, have been shown to play a role in residual disability after stroke. Premorbid physiological status has been less studied in stroke. However, loss of muscle mass and premorbid strength are prognostic factors for poor short- and medium-term functional recovery.

In this work, the body composition of patients in the acute phase of a stroke will be studied to determine whether its alteration is a poor prognostic factor in the short term (discharge from the initial hospitalization) and in the medium term (follow-up visit at 6 months). It will be studied using impedance analysis and morphological measurements on the temporal muscle.

In a cohort study of hospitalized patients in the acute phase of a stroke, measurements using a bioimpedance meter (InBody BWA) will be performed to measure a skeletal mass index (SMI) and phase angle. The properties of the temporal muscle (thickness and surface) will also be measured at T1, within 72 first hours after the stroke. Clinical and morphological data will also be collected (weight, height, initial deficit, lesion volume).

The aim of the work is to determine whether these body composition factors have an impact on the functional outcome of patients assessed at discharge and 6 months later. Functional assessment will be performed with modified Rankin score (mRS).

It is hypothesized that all body composition factors studied will be factors independent of the short- and medium-term functional prognosis.

Вмешательства

• Диагностический тест Modified Rankin scale
  Acute stroke patients will undergo modified rankin scale

Первичные конечные точки

• phase angle [Срок оценки: 72 hours after stroke]
• thickness of temporal muscle [Срок оценки: 72 hours after stroke]
• surface area of temporal muscle [Срок оценки: 72 hours after stroke]

Вторичные конечные точки (3)

• Modified Rankin Scale (mRS) [Срок оценки: Month 6]
• Modified Rankin Scale (mRS) [Срок оценки: Through month 3]
• skeletal muscular Index [Срок оценки: 72 hours after stroke]

Критерии участия

Критерии включения

• volunteer stroke patients in acute phase
• Age ≥ 18 years
• Having had a brain MRI
• Able to understand assessment guidelines
• Not having objected to participate in the study after being duly informed

Критерии исключения

• Person under tutorship or curatorship
• Person under court protection
• Persons deprived of their liberty
• Pregnant or breastfeeding women
• Have a pacemaker or defibrillator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• CHU d'ORLEANS — Orléans

Публикации

• Amir A, Pittel Z, Shahar A, Fisher A, Heldman E. Cholinotoxicity of the ethylcholine aziridinium ion in primary cultures from rat central nervous system. Brain Res. 1988 Jun 28;454(1-2):298-307. doi: 10.1016/0006-8993(88)90830-x. PMID 3409012
• Nozoe M, Kubo H, Kanai M, Yamamoto M, Okakita M, Suzuki H, Shimada S, Mase K. Reliability and validity of measuring temporal muscle thickness as the evaluation of sarcopenia risk and the relationship with functional outcome in older patients with acute stroke. Clin Neurol Neurosurg. 2021 Feb;201:106444. doi: 10.1016/j.clineuro.2020.106444. Epub 2021 Jan 1. PMID 33395619
• Katsuki M, Kakizawa Y, Nishikawa A, Yamamoto Y, Uchiyama T, Agata M, Wada N, Kawamura S, Koh A. Temporal Muscle and Stroke-A Narrative Review on Current Meaning and Clinical Applications of Temporal Muscle Thickness, Area, and Volume. Nutrients. 2022 Feb 6;14(3):687. doi: 10.3390/nu14030687. PMID 35277046
• Li YX, Hou J, Liu WY. Long-term prognostic significance of sarcopenia in acute ischemic stroke. Medicine (Baltimore). 2022 Aug 26;101(34):e30031. doi: 10.1097/MD.0000000000030031. PMID 36042682
• Nagano A, Shimizu A, Maeda K, Ueshima J, Inoue T, Murotani K, Ishida Y, Mori N. Predictive Value of Temporal Muscle Thickness for Sarcopenia after Acute Stroke in Older Patients. Nutrients. 2022 Nov 27;14(23):5048. doi: 10.3390/nu14235048. PMID 36501078
• Dubinski D, Won SY, Mattes I, Trnovec S, Behmanesh B, Cantre D, Baumgarten P, Dinc N, Konczalla J, Wittstock M, Freiman TM, Gessler F. Frailty in cerebellar ischemic stroke-The significance of temporal muscle thickness. Front Neurol. 2023 Sep 26;14:1193685. doi: 10.3389/fneur.2023.1193685. eCollection 2023. PMID 37822528
• Namgung HG, Hong S, Choi YA. Association of Temporalis Muscle Mass with Early Cognitive Impairment in Older Patients with Acute Ischemic Stroke. J Clin Med. 2023 Jun 15;12(12):4071. doi: 10.3390/jcm12124071. PMID 37373767

Идентификаторы

NCT: NCT06589297 · CHUO-2024-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗