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

Stroke Clinical Trial

— FRAM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03259932
• Other study ID #: GREMEAUX PHRC I 2015
• Status: Withdrawn
• Phase: N/A
• Start date: October 2017
• Est. completion date: October 2020

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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"..

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• no physical activity
no physical activity
• physical activity
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue relief (assessed by the Fatigue Severity Scale)		4 months after the stroke