NCT03928990

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

April 24, 2019

Last Update Submit

April 24, 2019

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Experimental arm

EXPERIMENTAL
Device: ActiGraph accelerometer

Interventions

ActiGraph accelerometerDEVICE

ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer

Experimental arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Yoshimasa Sagawa Jr., PhD

CONTACT

00333 81 21 87 51ysagawajunior@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 26, 2019

Study Start

January 15, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations

FR(1)