A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Combined program
* Behavioral: Physiotherapy in private practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined program<br>Combined program with physiotherapy, endurance training and resistance training. 120 patients will receive this combined program | Behavioral: Combined program<br>* Combined program with physiotherapy, endurance training and resistance training<br>|
| Active Comparator: Physiotherapy<br>Active comparator: physiotherapy in private practice 120 patients will receive this usual rehabilitation | Behavioral: Physiotherapy in private practice<br>* Physiotherapy in private practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walk Test | 6 Minute Walk Test (6MWT) at the end of the rehabilitation program (Time Frame : at one month M1) | 6 Minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional tests | 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 | 20 Minutes | 
| Aerobic capacity | Aerobic capacity (V02 max) | 1h | 
| Strength and fatigue of the knee flexors and extensors | Assessment of maximal voluntary strength using an isokinetic dynamometer or assessment of maximal voluntary strength using the 1-RM estimation | 45 min | 
| Clinical assessment | Spasticity assessment (Modified Ashworth Scale), passive range of motion of lower limb joint, lower limb strength (Medical Research Council scale), self questionnaire of pain. | 45 min | 
| Balance (Berg Balance scale) and postural control assessment |  | 15 min | 
| Quality of Life assessment | 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) | 55 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, Rehabilitation, Chronic evolutive disease, Physiotherapy, Resistance training, Endurance training