Study Stopped
The study could not be set up due to recruitment and feasibility problems
Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without Physical Training
FRAM
Personalised Physical Training Associated With Usual Management Versus Usual Management Alone on Fatigue and Recovery After Minor Stroke: Randomised Controlled Trial
1 other identifier
interventional
N/A
0 countries
N/A
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"..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2017
Typical duration for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2017
CompletedFirst Posted
Study publicly available on registry
August 24, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedFebruary 28, 2024
February 1, 2024
3 years
August 4, 2017
February 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Fatigue relief (assessed by the Fatigue Severity Scale)
4 months after the stroke
Study Arms (2)
usual management
OTHERphysical training
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- National health insurance cover
- st 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)
You may not qualify if:
- 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)
- Pre-stroke Rankin score ≥ 3
- Pregnant patient
- Patient under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 34695300DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2017
First Posted
August 24, 2017
Study Start
October 1, 2017
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
February 28, 2024
Record last verified: 2024-02