Body Composition and Acute Stroke

NCT ID: NCT06589297

Last Updated: 2025-01-23

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2028-06-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Acute Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Acute stroke patients

Acute stroke patients

Group Type OTHER

Modified Rankin scale

Intervention Type DIAGNOSTIC_TEST

Acute stroke patients will undergo modified rankin scale

Interventions

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Modified Rankin scale

Acute stroke patients will undergo modified rankin scale

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Person under tutorship or curatorship
* Person under court protection
* Persons deprived of their liberty
* Pregnant or breastfeeding women
* Have a pacemaker or defibrillator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Canan OZSANCAK, PH

Role: PRINCIPAL_INVESTIGATOR

CHU ORLEANS

Locations

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CHU d'ORLEANS

Orléans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Canan OZSANCAK, PH

Role: CONTACT

0033238229971

Facility Contacts

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Canan OZSANCAK, Ph

Role: primary

+33238229971

References

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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.

Reference Type BACKGROUND
PMID: 3409012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33395619 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35277046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36042682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36501078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37822528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37373767 (View on PubMed)

Other Identifiers

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CHUO-2024-04

Identifier Type: -

Identifier Source: org_study_id

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