Clinical trial NCT01871818: A Trial to Compare the Effectiveness of Two Rehabilitation Programs for Multiple Sclerosis Patients
Official title: A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Rehabilitation
Chronic evolutive disease
Physiotherapy
Resistance training
Endurance training
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: 6 Minutes
Secondary outcomes:
measure: Functional tests
timeFrame: 20 Minutes
measure: Aerobic capacity
timeFrame: 1h
measure: Strength and fatigue of the knee flexors and extensors
timeFrame: 45 min
measure: Clinical assessment
timeFrame: 45 min
measure: Balance (Berg Balance scale) and postural control assessment
timeFrame: 15 min
measure: Quality of Life assessment
timeFrame: 55 min
Other outcomes:
Locations:
city: Garches
country: France
facility: Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE
state: Hauts DE Seine
Study officials:
affiliation: Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
name: Djamel Bensmail, MD
role: PRINCIPAL_INVESTIGATOR
References: