ClinicalTrials.Veeva

Menu

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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Withdrawn

Conditions

Stroke

Treatments

Other: physical activity
Other: no physical activity

Study type

Interventional

Funder types

Other

Identifiers

NCT03259932
GREMEAUX PHRC I 2015

Details and patient eligibility

About

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"..

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

usual management
Other group
Treatment:
Other: no physical activity
physical training
Experimental group
Treatment:
Other: physical activity

Trial contacts and locations

1

Loading...

Central trial contact

Vincent GREMEAUX, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems