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Body Composition and Acute Stroke

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06589297
Acronym
PREDISTROKE
Enrollment
250
Registered
2024-09-19
Start date
2024-10-10
Completion date
2028-06-01
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke

Keywords

Stroke, Body composition, Bioimpedancemetry, Temporal muscle, Sarcopenia

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTModified Rankin scale

Acute stroke patients will undergo modified rankin scale

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
phase angle72 hours after stroke
thickness of temporal muscle72 hours after stroke
surface area of temporal muscle72 hours after stroke

Secondary

MeasureTime frameDescription
Modified Rankin Scale (mRS)Month 6The modified Rankin Scale is used to assess the disability of patients in the acute phase of stroke recovery. It consists of a single item, with 5 levels corresponding to no disability, mild disability, moderate disability, moderately severe disability and severe disability.
skeletal muscular Index72 hours after stroke

Countries

France

Contacts

CONTACTMarc VERIN, PUPH
marc.verin@chu-orleans.fr0238651369
PRINCIPAL_INVESTIGATORMarc VERIN, PUPH

CHU ORLEANS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026