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

Multiple Sclerosis Clinical Trial

— ACTISEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03928990
• Other study ID #: P/2018/376
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: January 2021

Study information

• Verified date: April 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Yoshimasa Sagawa Jr., PhD
• Phone: 00333 81 21 87 51
• Email: ysagawajunior[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• ActiGraph accelerometer
ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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