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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ActiGraph accelerometer
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU de BesançonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental arm

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
April 24, 2019
Last Updated
April 24, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03928990
Brief Title
Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life
Acronym
ACTISEP
Official Title
Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ActiGraph accelerometer
Intervention Description
ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer
Primary Outcome Measure Information:
Title
Patient's feeling
Description
Patient's feeling measured at each step of the procedure, measured with Visual Analogique Scale (scored from 0 = not painful to 10 = extremely painful)
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoshimasa Sagawa Jr., PhD
Phone
00333 81 21 87 51
Email
ysagawajunior@chu-besancon.fr
Facility Information:
Facility Name
CHU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshimasa Sagawa, PhD
Phone
0033 3 81 21 87 51
Email
ysagawajunior@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Thierry Moulin, MD PhD
First Name & Middle Initial & Last Name & Degree
Pierre Decavel, MD PhD

12. IPD Sharing Statement

Learn more about this trial

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

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