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

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: Multiple Sclerosis
• Intervention / Treatment: Device: ActiGraph accelerometer

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CHU de Besançon
    • Contact: Yoshimasa Sagawa, PhD; Phone Number: 0033 3 81 21 87 51; Email: ysagawajunior@chu-besancon.fr
    • Principal Investigator: THIERRY MOULIN, MD phD
    • Sub-Investigator: Pierre Decavel, MD PhD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

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: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• 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