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

April 24, 2019 updated by: Centre Hospitalier Universitaire de Besancon
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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 Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • CHU de Besançon
        • Contact:
        • Principal Investigator:
          • THIERRY MOULIN, MD phD
        • Sub-Investigator:
          • Pierre Decavel, MD PhD

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Device: ActiGraph accelerometer
ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

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 (Actual)

January 15, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (Actual)

April 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2018/376

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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