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

NCT ID: NCT03928990

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental arm

Group Type EXPERIMENTAL

ActiGraph accelerometer

Intervention Type DEVICE

ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer

Interventions

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ActiGraph accelerometer

ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Besançon

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Yoshimasa Sagawa Jr., PhD

Role: CONTACT

00333 81 21 87 51

Facility Contacts

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Yoshimasa Sagawa, PhD

Role: primary

0033 3 81 21 87 51

Other Identifiers

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P/2018/376

Identifier Type: -

Identifier Source: org_study_id

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