Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, Rehabilitation, Chronic evolutive disease, Physiotherapy, Resistance training, Endurance training
Brief summary
The purpose of this study was to compare the effectiveness of two rehabilitation programs (one month) in patients with multiple sclerosis. The first program is combined with physiotherapy, endurance training and resistance training. The second one is physiotherapy in private practice. Another purpose is to assess the length of the benefits of the combined program.
Detailed description
This study will include 240 patients with a diagnosis of Multiple Sclerosis and with an Expanded Disability Status Scale ≤ 5. Patients will be divided into 2 groups, according to a randomization design. At recruitment (J0), after rehabilitation (M1) and at follow up (M3 and M6) each patient will be tested for the primary and secondary outcomes.
Interventions
BEHAVIORALCombined program
Combined program with physiotherapy, endurance training and resistance training
BEHAVIORALPhysiotherapy in private practice
Physiotherapy in private practice
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 year or over * Able to walk independently without use of assistance 200 meters Expanded Disability Status Scale ≤5 * No relapse within the last three months * No current or recent (six months) participation in intensive rehabilitation * No recent modification (six months) of medications for MS * Patients who received and signed information and informed consent
Exclusion criteria
* Cognitive impairments which could interfere with the ability to fully engage the rehabilitation program. * Recent involvement (three months) in another interventional research study * A complicating medical condition or orthopedic diagnosis that limits rehabilitation * Cardiac or respiratory disease that interfere with endurance training * Patient with safety measure * Pregnant women, breastfeeding * No affiliation to a social security
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test | 6 Minutes | 6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aerobic capacity | 1h | Aerobic capacity (V02 max) |
| Strength and fatigue of the knee flexors and extensors | 45 min | Assessment of maximal voluntary strength using an isokinetic dynamometer or assessment of maximal voluntary strength using the 1-RM estimation |
| Functional tests | 20 Minutes | Functional tests: 10 meters Walk Test, Timed up and go test, Time to ascend and descend stairs, 6 Minute Walk Test Time frame:10 meters walk test = 2 min ; time up and going test= 4 min ; Time to ascend and descend stairs = 4 min ; et 6min walk = 6min |
| Balance (Berg Balance scale) and postural control assessment | 15 min | — |
| Quality of Life assessment | 55 min | Quality of Life assessed by self-reported questionnaire (SEP -59; EQ-5D), mood (HAD), MSIS-29, auto-questionnaire estimating the fatigue (Fatigue Severity Scale, Modified Fatigue Impact Scale) |
| Clinical assessment | 45 min | Spasticity assessment (Modified Ashworth Scale), passive range of motion of lower limb joint, lower limb strength (Medical Research Council scale), self questionnaire of pain. |
Countries
France
Outcome results
None listed