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Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life (ACTISEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03928990
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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Brief Summary:
This study aims to assess the feasibility of a protocol determining individual moderate-to-vigorous physical activity (MVPA) thresholds, among multiple sclerosis patients, in routine medical practice.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: ActiGraph accelerometer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental arm Device: ActiGraph accelerometer
ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer


Outcome Measures
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Primary Outcome Measures :
  1. Patient's feeling [ Time Frame: Day 1 ]
    Patient's feeling measured at each step of the procedure, measured with Visual Analogique Scale (scored from 0 = not painful to 10 = extremely painful)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 to 80 years old
  • Multiple sclerosis according to McDonald criteria ;
  • Expanded Disability Status Scale (EDSS) between 0 and 6.5 ;
  • Patient able to move with or without mechanical assistance.

Exclusion Criteria:

  • Deterioration of neurological symptomatology within 60 day before enrollment ;
  • Changes brought to the multiple sclerosis treatment within 6 months before enrollment ;
  • Introduction of a treatment acting on spasticity or fatigue within 30 day before enrollment
  • Changes brought to reeducation protocol throughout the duration of the study
  • Patient unable to provide an effort equivalent to 3 times the resting metabolic value = 3 Metabolic Equivalent of Task (METs).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928990


Contacts
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Contact: Yoshimasa Sagawa Jr., PhD 00333 81 21 87 51 ysagawajunior@chu-besancon.fr

Locations
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France
CHU de Besançon Recruiting
Besançon, France, 25000
Contact: Yoshimasa Sagawa, PhD    0033 3 81 21 87 51    ysagawajunior@chu-besancon.fr   
Principal Investigator: Thierry Moulin, MD PhD         
Sub-Investigator: Pierre Decavel, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03928990    
Other Study ID Numbers: P/2018/376
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases