Body Composition and Acute Stroke (PREDISTROKE)

January 29, 2026 updated by: Centre Hospitalier Régional d'Orléans

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Orléans, France, 45067
        • Recruiting
        • CHU d'Orléans
        • Contact:
        • Principal Investigator:
          • Marc VERIN, PUPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Acute stroke patients
Diagnostic test: Modified Rankin scale
Acute stroke patients will undergo modified rankin scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
phase angle
Time Frame: 72 hours after stroke
72 hours after stroke
thickness of temporal muscle
Time Frame: 72 hours after stroke
72 hours after stroke
surface area of temporal muscle
Time Frame: 72 hours after stroke
72 hours after stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRS)
Time Frame: Month 6
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.
Month 6
Modified Rankin Scale (mRS)
Time Frame: 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.
Through month 3
skeletal muscular Index
Time Frame: 72 hours after stroke
72 hours after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Marc VERIN, PUPH, CHU Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 5, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUO-2024-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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