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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03259932

Acronym

FRAM

Enrollment

Registered

2017-08-24

Start date

2017-10-31

Completion date

2020-10-31

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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..

Interventions

OTHERno physical activity

no physical activity

OTHERphysical 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Fatigue relief (assessed by the Fatigue Severity Scale)	4 months after the stroke

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026