Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00841-38 | Other Identifier | IDRCB |
Not provided
Not provided
low inclusion rates
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.
Chronic fatigue is a very common symptom reported (80%) by patients with multiple sclerosis (MS), regardless of the type of MS and level of disability. Despite the clinical importance of MS-related fatigue, pharmacological treatments remain quite ineffective in preventing or treating chronic fatigue.
Recently, physical activity has proven to be an effective therapy with benefits on chronic fatigue as well as on different functions (muscular, cardiorespiratory, cognitive, etc.). Nevertheless, the effects of physical exercise may vary between MS patients, as MS is a heterogeneous disease and does not affect each individual in the same way. The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional exercise | Active Comparator | fatigued multiple sclerosis patients with a traditional training program |
|
| Individual exercise | Experimental | tired multiple sclerosis patients with an adapted and individualized training program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted and individualized physical training program | Other | Physical training program adapted and individualized according to each patient in this group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic fatigue score | assessed using the Fatigue Severity Scale (FSS) questionnaire before and after an individualized re-training program compared to a traditional re-training program in MS patients. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| cardiorespiratory fitness | evaluated by measuring the maximum oxygen consumption (VO2max) during an incremental exercise on a cycloergometer. | Month 3 |
| Hematological parameters | red blood cell and hemoglobin levels measured by spectrophotometry. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean Philippe CAMDESSANCHE, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000064 | Acclimatization |
| ID | Term |
|---|---|
| D000222 | Adaptation, Physiological |
| D010829 | Physiological Phenomena |
| D000220 | Adaptation, Biological |
| D001686 | Biological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| traditional training program | Other | Same training program for all patients in this group |
|
| Month 3 |
| Inflammatory parameters | c-reactive protein | Month 3 |
| quality of sleep | actigraphy measurements and sleep diary records | Month 3 |
| cortical activation level | transcranial magnetic stimulation | Month 3 |
| cortico-spinal excitability | transcranial magnetic stimulation | Month 3 |
| neuromuscular fatigue of peripheral function | electrical nerve stimulation | Month 3 |
| Analysis overall quality of life : Fatigue questionnaire | Fatigue questionnaire by Modified Fatigue Impact Scale (MFIS) results | Month 3 |
| Analysis overall quality of life :Quality of Life | Quality of Life Questionnaire by SEP-59 results | Month 3 |
| Analysis overall quality of life :Depression | Depression Questionnaire by Center for Epidemiologic Studies Depression (CES-D) results | Month 3 |
| Analysis overall quality of life : Sleep Quality | Sleep Quality Questionnaire by Pittsburgh Sleep Quality Index (PSQ-I) results | Month 3 |
| Analysis overall quality of life : Physical Activity | Physical Activity Questionnaire by Godin Leisure-Time Exercise Questionnaire (GLTEQ) results | Month 3 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |