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

Not Applicable

Recruiting

• Conditions: Fatigue; Sclerosis
• Interventions: Other: Traditional exercise; Other: Individualized exercise

• Registration Number: NCT06201026
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

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 Timeline

• Study Start: 2023-09-12
• Study First Submitted: 2023-12-12
• Study First Submitted QC: 2023-12-29
• Study First Posted: 2024-01-11
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-07-01
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional exercise group in newly diagnosed patients with MS (SEP-R-TEM)	Traditional exercise	Newly diagnosed patients with MS who will be part of the group doing traditional exercises
Individualized exercise group in newly diagnosed patients with MS (SEP-R-IND)	Individualized exercise	Newly diagnosed patients with MS who will be part of the group doing individualized exercises
Traditional exercise group in advanced diagnosed patients with MS (SEP-A-TEM)	Traditional exercise	Advanced diagnosed patients with MS who will be part of the group doing traditional exercises
Individualized exercise group in advanced diagnosed patients with MS (SEP-A-IND)	Individualized exercise	Advanced diagnosed patients with MS who will be part of the group doing individualized exercises.

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale (FSS)	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chu de Saint-Etienne; 🇫🇷 Saint-Étienne, France