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

NCT ID: NCT03259932

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2020-10-31

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"..

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

usual management

Group Type: OTHER

no physical activity

Intervention Type: OTHER

no physical activity

physical training

Group Type: EXPERIMENTAL

physical activity

Intervention Type: OTHER

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.

Interventions

no physical activity

no physical activity

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 34695300 (View on PubMed)

Other Identifiers

GREMEAUX PHRC I 2015

Identifier Type: -

Identifier Source: org_study_id