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

Study Overview
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Brief Summary
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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..

Official Title
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Personalised Physical Training Associated With Usual Management Versus Usual Management Alone on Fatigue and Recovery After Minor Stroke: Randomised Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Other: no physical activity
* Other: physical activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: usual management<br> | Other: no physical activity<br>* no physical activity<br>|
| Experimental: physical training<br> | Other: physical activity<br>* Rehabilitation program will start 4 weeks after discharge from acute care (S4), for a duration of 8 weeks (3 sessions / week). Physical training will include aerobic exercises 30-60 minutes at 50-80% of HRmax, associated with muscle building exercises in circuit training (20 min), and balance and flexibility exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue relief (assessed by the Fatigue Severity Scale) |  | 4 months after the stroke |