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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
no physical activity
physical activity
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHu Dijon Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

usual management

physical training

Arm Description

Outcomes

Primary Outcome Measures

Fatigue relief (assessed by the Fatigue Severity Scale)

Secondary Outcome Measures

Full Information

First Posted
August 4, 2017
Last Updated
August 23, 2017
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT03259932
Brief Title
Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without Physical Training
Acronym
FRAM
Official Title
Personalised Physical Training Associated With Usual Management Versus Usual Management Alone on Fatigue and Recovery After Minor Stroke: Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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"..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
usual management
Arm Type
Other
Arm Title
physical training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
no physical activity
Intervention Description
no physical activity
Intervention Type
Other
Intervention Name(s)
physical activity
Intervention Description
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 Measure Information:
Title
Fatigue relief (assessed by the Fatigue Severity Scale)
Time Frame
4 months after the stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent GREMEAUX, MD
Phone
3.80.29.38.15
Ext
+33
Email
vincent.gremeaux@chu-dijon.fr
Facility Information:
Facility Name
CHu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loic FOUCHER, MD
Phone
3.80.29.33.71
Ext
+33
Email
loic.foucher@chu-dijon.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
34695300
Citation
Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
Results Reference
derived

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

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