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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03928990

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted April 26, 2019

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.

  • Condition or Disease:Multiple Sclerosis
  • Intervention/Treatment: Device: ActiGraph accelerometer
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Assesment of Physical Activity Level of Patients With Multiple Sclerosis: From Laboratory to Real Life
  • Actual Study Start Date: January 2019
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: January 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Experimental arm
Device: ActiGraph accelerometer
ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer
Outcome Measures
  • Primary Outcome Measures: 1. 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)
Eligibility Criteria
  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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).

Contacts and Locations
Contacts

Contact: Yoshimasa Sagawa Jr., PhD 00333 81 21 87 51 ysagawajunior@chu-besancon.fr

Locations

France
CHU de Besançon
Besançon

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

More Information
  • Responsible Party: Centre Hospitalier Universitaire de Besancon
  • ClinicalTrials.gov Identifier: NCT03928990 History of Changes
  • Other Study ID Numbers: P/2018/376
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: April 26, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Sclerosis Multiple Sclerosis