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L'essai clinique NCT06201026 (MovelySEP) pour Sclérose, Fatigue est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis (MovelySEP)
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT06201026 (MovelySEP) est un essai interventionnel pour Sclérose, Fatigue. Son statut actuel est : en recrutement. L'étude a débuté le 12 septembre 2023 et vise à recruter 96 participants. Dirigé par Centre Hospitalier Universitaire de Saint Etienne, l'essai devrait être terminé d'ici le 15 septembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 23 octobre 2024.
Résumé succinct
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 détaillée
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.
Titre officiel
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.
Conditions
ScléroseFatigueAutres identifiants de l'essai
- MovelySEP
- 23CH024
- ANSM (Autre Identifiant) (2023-A00535-40)
Numéro NCT
Date de début (réel)
2023-09-12
Dernière mise à jour publiée
2024-10-23
Date de fin (estimée)
2025-09-15
Inscription (estimée)
96
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Fatigue
Neuromuscular function
Muscle characteristics
Physical capacity
Neuromuscular function
Muscle characteristics
Physical capacity
Objectif principal
Soins de soutien
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifTraditional 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 | Exercice traditionnel Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home |
ExpérimentalIndividualized 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 | 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. |
Comparateur actifTraditional 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 | Exercice traditionnel Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home |
ExpérimentalIndividualized 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. | 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. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
cross sectional area (µm2) of type IIA fibers from the vastus lateralis muscle biopsies | ONLY FOR MS-N PATIENTS | Week 17 |
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 |
Maximal oxygen uptake (VO2max) (ml/min) | Cardiac stress test | Week 15 |
Percentage of voluntary activation (%) | Voluntary Activation of the extensor muscles of the knee by peripheral nerve stimulation | Week 16 |
C-reactive protein (CRP) (mg/l) | Blood sample | Week 15 |
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement | Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle | Week 16 |
Maximal voluntary contraction (MVC) of the hand grip measurement | Week 16 | |
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 |
Quality of life questionnaire (SEP-59) | Scale from 0 (worst quality of life) to 100 (best quality of life) | Week 15 |
Epworth score | From 0 to 24
The higher the score, the greater the degree of drowsiness | Week 15 |
Pittsburgh Sleep Quality Index (PSQI) | From 0 to 21 The higher the score, the worse the quality of sleep | Week 15 |
Hospital Anxiety and Depression scale (HAD) | From 0 to 42 The higher the score, the greater the anxiety and depression | Week 15 |
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
- 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
- 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
Centre Hospitalier Universitaire de Saint EtienneContact central de l'essai
Contact: Jean-Philippe CAMDESSANCHE, PHD, (4)77120559, [email protected]
Contact: Leonard FEASSON, PHD, (4)77120559, [email protected]
1 Centres de l'essai dans 1 pays
Chu de Saint-Etienne, Saint-Etienne, 42055, France
JEAN-PHILIPPE CAMDESSANCHE, PHD, Contact, (4)77120559, [email protected]
En recrutement