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

Fatigue Clinical Trial

— MovelySEP  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201026
• Other study ID #: 23CH024
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: September 15, 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Jean-Philippe CAMDESSANCHE, PHD
• Phone: (4)77120559
• Email: j.phillippe.camdessanche[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 15, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Traditional exercise
Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home
• 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.

Locations

Country	Name	City	State
France	Chu de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale (FSS)	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	cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies	ONLY FOR MS-N PATIENTS	Week 17
Secondary	Muscle enzymatic activity (UI)	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
Secondary	Maximal oxygen uptake (VO2max) (ml/min)	Cardiac stress test	Week 15
Secondary	Percentage of voluntary activation (%)	Voluntary Activation of the extensor muscles of the knee by peripheral nerve stimulation	Week 16
Secondary	C-reactive protein (CRP) (mg/l)	Blood sample	Week 15
Secondary	Maximal voluntary contraction (MVC) of the knee extensor muscle measurement	Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle	Week 16
Secondary	Maximal voluntary contraction (MVC) of the hand grip measurement		Week 16
Secondary	Balance test (s)	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
Secondary	Quality of life questionnaire (SEP-59)	Scale from 0 (worst quality of life) to 100 (best quality of life)	Week 15
Secondary	Epworth score	From 0 to 24; The higher the score, the greater the degree of drowsiness	Week 15
Secondary	Pittsburgh Sleep Quality Index (PSQI)	From 0 to 21 The higher the score, the worse the quality of sleep	Week 15
Secondary	Hospital Anxiety and Depression scale (HAD)	From 0 to 42 The higher the score, the greater the anxiety and depression	Week 15