Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603701
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Sarcopenia in the Acute Stroke
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Follow up of Strength and Body Composition With Impedancemeter Device During the First 10 Days After Acute Stroke
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SARCOSTROKE
Brief Summary:
Regardless of the cause of immobilization within days or weeks there is rapidly a decrease in strength and muscle mass which can lead to sarcopenia In severe strokes immobilization and neurologic damage may be added to promote sarcopenia Several studies in Asian populations confirm rapid increases in sarcopenia rates after stroke but there are only rare data in Western populations The aim of this work is to monitor during the first 10 days after a severe stroke leading to a reduction in ambulation the evolution of muscle strength studied in dynamometry body composition studied by impedance measurement and sarcopenia rates Investigators will also look for factors that predict the occurrence of this sarcopenia such as sex age initial deficiency stroke volume swallowing disorders etc
Detailed Description:
In stroke patients muscle damage combines many mechanisms such as immobilization nutritional disorders sympathetic activity inflammation and denervation These general factors explain that post-stroke sarcopenia is also observed on the side considered healthy
Several meta-analyzes have been carried out on this subject In the study by Inoue et al which brings together 35 studies on the subject the rates of sarcopenia observed were overall of the order of 15 before the stroke of 30 in the 10 days post-stroke and of the order of 50 in the first semester Only about 10 studies have been performed in the acute phase However the majority of these studies were performed in Asian populations 32 of them But this is a population with demographic and physiological characteristics that are different from those in the West Thus body mass indices are lower and the representation of older people is higher in the population the Japanese population is the oldest in the world
Body composition may be a predictor of the course of recovery from stroke In a cohort study it was thus shown by bioimpedance measurements that patients with the lowest muscle mass index had more severe neurological deficits at admission They also had poorer functioning and longer hospital stays Muscle mass is an independent variable in predicting what happens to people who have had a stroke
Strokes cause motor deficits that reduce movement on the deficit side but also on the unaffected side Sarcopenia loss of strength and muscle mass develops in the first few days after a stroke and worsens the consequences of neurologic damage While immobilization rapidly leads to sarcopenia sarcopenia has been poorly studied in acute stroke especially in Asian populations which are unrepresentative of Western populations
The aims of this work are to
1 Longitudinally determine rates of sarcopenia in the acute phase of stroke during follow-up over the first 10 days after stroke
2 Determine the factors that predict the occurrence of sarcopenia age degree of initial deficiency lesion volume etc
3 Track body composition by segment 4 limbs and trunk over time in impedance measurement particularly by distinguishing between deficit and nondeficit Investigators will distinguish the usual parameters skeletal muscle mass angle phase
4 Monitor motor recovery of the deficient upper limb and determine whether muscle mass is a prognostic factor for recovery
Measurement will be done at three time T1 T2 T3 T1 corresponds to the first 72 hours post stroke T2 corresponds at 5 days -1 days T2 corresponds at 8 days -1 days
Several meta-analyzes have been carried out on this subject In the study by Inoue et al which brings together 35 studies on the subject the rates of sarcopenia observed were overall of the order of 15 before the stroke of 30 in the 10 days post-stroke and of the order of 50 in the first semester Only about 10 studies have been performed in the acute phase However the majority of these studies were performed in Asian populations 32 of them But this is a population with demographic and physiological characteristics that are different from those in the West Thus body mass indices are lower and the representation of older people is higher in the population the Japanese population is the oldest in the world
Body composition may be a predictor of the course of recovery from stroke In a cohort study it was thus shown by bioimpedance measurements that patients with the lowest muscle mass index had more severe neurological deficits at admission They also had poorer functioning and longer hospital stays Muscle mass is an independent variable in predicting what happens to people who have had a stroke
Strokes cause motor deficits that reduce movement on the deficit side but also on the unaffected side Sarcopenia loss of strength and muscle mass develops in the first few days after a stroke and worsens the consequences of neurologic damage While immobilization rapidly leads to sarcopenia sarcopenia has been poorly studied in acute stroke especially in Asian populations which are unrepresentative of Western populations
The aims of this work are to
1 Longitudinally determine rates of sarcopenia in the acute phase of stroke during follow-up over the first 10 days after stroke
2 Determine the factors that predict the occurrence of sarcopenia age degree of initial deficiency lesion volume etc
3 Track body composition by segment 4 limbs and trunk over time in impedance measurement particularly by distinguishing between deficit and nondeficit Investigators will distinguish the usual parameters skeletal muscle mass angle phase
4 Monitor motor recovery of the deficient upper limb and determine whether muscle mass is a prognostic factor for recovery
Measurement will be done at three time T1 T2 T3 T1 corresponds to the first 72 hours post stroke T2 corresponds at 5 days -1 days T2 corresponds at 8 days -1 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None