Body Composition and Acute Stroke

Not Applicable

Recruiting

• Conditions: Acute Stroke
• Interventions: Diagnostic Test: Modified Rankin scale

• Registration Number: NCT06589297
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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.

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-19
• Study Start: 2024-10-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute stroke patients	Modified Rankin scale	Acute stroke patients

Primary Outcome Measures

Name	Time	Method
phase angle	72 hours after stroke
thickness of temporal muscle	72 hours after stroke
surface area of temporal muscle	72 hours after stroke

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS)	Through month 3	The 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 Index	72 hours after stroke

Trial Locations

Locations (1)

CHU d'ORLEANS; 🇫🇷 Orleans, France