Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2023-A00535-40 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional exercise group in newly diagnosed patients with MS (SEP-R-TEM) | Active Comparator | 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) | Experimental | 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) | Active Comparator | 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) | Experimental | Advanced diagnosed patients with MS who will be part of the group doing individualized exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional exercise | Other | Patients will perform aerobic and resistance exercises that are consistent with the exercise guidelines for MS patients at home |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
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. |
Not provided
Inclusion criteria
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Philippe CAMDESSANCHE, PHD | Contact | (4)77120559 | +33 | j.phillippe.camdessanche@chu-st-etienne.fr |
| Leonard FEASSON, PHD | Contact | (4)77120559 | +33 | leonard.feasson@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe CAMDESSANCHE, PHD | CHU DE SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu de Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012598 | Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Individualized exercise | Other | 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. |
|
| 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 |