Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without Physical Training

Not Applicable

Withdrawn

• Conditions: Stroke
• Interventions: Other: no physical activity; Other: physical activity

• Registration Number: NCT03259932
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

After a minor stroke, patients frequently report complaints such as fatigue and difficulty with certain everyday motor tasks, leading to a marked deterioration in their quality of life. The aim of this study is to show that the implementation of a personalised physical activity programme, starting 1 month after the hospitalisation for minor stroke, significantly decreases the frequency of fatigue in these patients, in comparison with usual management "in real life"..

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-24
• Study Start: 2017-10
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age > 18 years
• National health insurance cover
• 1st minor ischaemic stroke (initial NIH score ≤ 4)
• Satisfactory neurological recovery at discharge from hospital (modified Rankin score ≤2)
• Patient living close to the participating centre (<50 km)
• With early post-stroke fatigue (FFS score ≥ 4 at the definitive inclusion visit (W3))

Exclusion Criteria

• haemorrhagic stroke
• History of ischaemic or haemorrhagic stroke with clinical manifestations
• History of TIA
• MMS ≤ 24
• Pre-existing dementia (defined according to DSM IV criteria)
• Neurosensory or orthopaedic disorders requiring permanent technical support before the stroke and making reconditioning impossible
• Aggravation of the neurological status after the initial hospitalisation (NIH score ≥ 6)
• Recurrence of the cerebrovascular event or onset of an acute cardio-vascular event between the screening and definitive inclusion
• Pre-stroke Rankin score ≥ 3
• Pregnant patient
• Patient under guardianship

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual management	no physical activity	-
physical training	physical activity	-

Primary Outcome Measures

Name	Time	Method
Fatigue relief (assessed by the Fatigue Severity Scale)	4 months after the stroke