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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259932
Recruitment Status : Unknown
Verified August 2017 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
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"..

Condition or disease Intervention/treatment Phase
Stroke Other: no physical activity Other: physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalised Physical Training Associated With Usual Management Versus Usual Management Alone on Fatigue and Recovery After Minor Stroke: Randomised Controlled Trial
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
usual management Other: no physical activity
no physical activity

Experimental: physical training Other: 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.




Primary Outcome Measures :
  1. Fatigue relief (assessed by the Fatigue Severity Scale) [ Time Frame: 4 months after the stroke ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259932


Contacts
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Contact: Vincent GREMEAUX, MD 3.80.29.38.15 ext +33 vincent.gremeaux@chu-dijon.fr

Locations
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France
CHu Dijon Bourgogne
Dijon, France, 21079
Contact: Loic FOUCHER, MD    3.80.29.33.71 ext +33    loic.foucher@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03259932    
Other Study ID Numbers: GREMEAUX PHRC I 2015
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Fatigue
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases