Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis (MovelySEP)

March 18, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne

Effects of Individualized, Home-based, Mobile App-guided Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis: a Randomized Controlled Trial.

Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symptom in MS patients (80%). Current pharmacological treatments for MS patients reduce the number of relapses and their severity but do not improve symptoms such as fatigue. Physical activity is a therapy that helps reduce this fatigue, in addition to improving muscular and cardiorespiratory functions. However, the results are not optimal because MS patients remain less active than the general population. The improvement of the benefits of exercise therapy could therefore be based on three approaches: personalization of the training program, home practice and early initiation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study will be to investigate the effects of individualized home-training, guided by a mobile application, to reduce fatigue in patients with newly (N) and advanced (A) diagnosed MS.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Relapsing-remitting MS (RRMS) defined according to the criteria of McDonald
  • MS diagnosed less than 2 years ago or whose first symptoms are estimated to be less than 5 years old OR MS diagnosed more than 2 years ago and whose first symptoms are estimated to be less than 5 years old
  • With a high level of fatigue, corresponding to an FSS score > 4
  • Expanded Disability Status Scale (EDSS) score < 4
  • Medical Research Council (MRC) testing ≥ 4 in all leg muscles
  • Ability to walk for 10 minutes without stopping (self-reported)
  • Have a mobile phone with internet access
  • Affiliated with or benefiting from a social security scheme
  • Have freely given their written consent after being informed of the aim, the procedure and the potential risks involved

Exclusion criteria

  • Spasticity or severe cerebellar ataxia in either leg.
  • Abnormal range of movement of the toes and/or ankle
  • Musculoskeletal injury that impairs pedalling
  • Appearance of a multiple sclerosis attack in the 90 days preceding the study
  • Recent adjustment of any medication or drug that may have an impact on fatigue: treatment of neuropathic pain: anti-epileptic and/or taking stimulants for fatigue (e.g. modafinil, amantadine, fampridine...)
  • History of comorbid illness or conditions that would compromise the subject's safety during the study
  • Participation at the same time in another medical intervention study or having participated in such a study in the 30 days prior to this study
  • Pregnant and breast-feeding women
  • Patients who are unable to understand the purpose of the study and the conditions under which it will be conducted, or who are unable to give their consent.
  • Patients deprived of their liberty or under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional exercise group in newly diagnosed patients with MS (SEP-R-TEM)
Newly diagnosed patients with MS who will be part of the group doing traditional exercises
Other: Traditional exercise
Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home
Experimental: Individualized exercise group in newly diagnosed patients with MS (SEP-R-IND)
Newly diagnosed patients with MS who will be part of the group doing individualized exercises
Other: Individualized exercise
Patients will performed a mobile-app guided program at home designed to address identified individual disabilities such as loss of muscle strength or cardiorespiratory deconditioning.
Active Comparator: Traditional exercise group in advanced diagnosed patients with MS (SEP-A-TEM)
Advanced diagnosed patients with MS who will be part of the group doing traditional exercises
Other: Traditional exercise
Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home
Experimental: Individualized exercise group in advanced diagnosed patients with MS (SEP-A-IND)
Advanced diagnosed patients with MS who will be part of the group doing individualized exercises.
Other: Individualized exercise
Patients will performed a mobile-app guided program at home designed to address identified individual disabilities such as loss of muscle strength or cardiorespiratory deconditioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Severity Scale (FSS)
Time Frame: Week 15

Change in the chronic fatigue score assessed using the FSS questionnaire before and after the training programme. From 1 to 7.

The higher the score, the greater the fatigue
Week 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies
Time Frame: Week 17
ONLY FOR MS-N PATIENTS
Week 17
Maximal oxygen uptake (VO2max) (ml/min)
Time Frame: Week 15
Cardiac stress test
Week 15
Percentage of voluntary activation (%)
Time Frame: Week 16
Voluntary Activation of the extensor muscles of the knee by peripheral nerve stimulation
Week 16
C-reactive protein (CRP) (mg/l)
Time Frame: Week 15
Blood sample
Week 15
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement
Time Frame: Week 16
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle
Week 16
Maximal voluntary contraction (MVC) of the hand grip measurement
Time Frame: Week 16
Week 16
Balance test (s)
Time Frame: Week 16
This test, performed in unipedal support, consists of asking the subject to hold the unipedal position for as long as possible, on the lower limb of his choice.
Week 16
Quality of life questionnaire (SEP-59)
Time Frame: Week 15
Scale from 0 (worst quality of life) to 100 (best quality of life)
Week 15
Epworth score
Time Frame: Week 15

From 0 to 24

The higher the score, the greater the degree of drowsiness
Week 15
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Week 15
From 0 to 21 The higher the score, the worse the quality of sleep
Week 15
Hospital Anxiety and Depression scale (HAD)
Time Frame: Week 15
From 0 to 42 The higher the score, the greater the anxiety and depression
Week 15
Muscle enzymatic activity (UI)
Time Frame: Week 17

ONLY FOR MS-N PATIENTS

The enzymatic activity is measured for the following enzymes :

  • Phosphofructokinase (PFK)
  • lactate dehydrogenase (LDH)
  • citrate synthase (CS)
  • cyclo-oxygenase (COx)

Enzymatic activity is measured in units international (UI) It indicates the rate of enzymatic reaction catalyzed by the enzyme, expressed in micromoles of substrate transformed (or product formed) per minute.
Week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Jean-Philippe CAMDESSANCHE, PHD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23CH024
  • ANSM (Other Identifier: 2024-A00286-41)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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