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

February 26, 2024 updated by: Centre Hospitalier Universitaire Dijon

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

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"..

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue relief (assessed by the Fatigue Severity Scale)
Time Frame: 4 months after the stroke
4 months after the stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2017

Primary Completion (Estimated)

October 1, 2020

Study Completion (Estimated)

October 1, 2020

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GREMEAUX PHRC I 2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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