Clinical trial NCT02352194: Physical Capacity and Rehabilitation of Patients With Multiple Sclerosis
Official title: Observational Study of the Physical Capacity of Patients With Multiple Sclerosis and Evaluation of the Effects of Usual Rehabilitation in the Day Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis (MS)
Keywords: Multiple Sclerosis, Physical therapy, Physical capacity, Fatigue
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with MS since at least 3 months

Brief summary: The purpose of this study is to assess the physical capacity of patients with multiple sclerosis and the effects of rehabilitation, encompassing physical therapy and physical activity as it is carried out in the day hospital of (the Physical and Rehabilitation Medicine department) at Garches Hospital. We will compare the results of assessments carried out before and after a standard rehabilitation program.

Detailed description: Single center, retrospective and prospective study.

In order to assess the efficiency of the of usual rehabilitation proposed to patients in the day hospital, assessments are systematically performed before and after the rehabilitation program:

1. Assessment of muscular strength and fatigue:

   Assessments of voluntary force will be those usually performed in the context of the evaluation of patients. The isokinetic dynamometer CON-TREX ® is a device that provides a quantified result of the torque developed in a predetermined joint area with a constant speed which is also defined in advance.

   The assessment includes an assessment of the strength in isometric contraction (at 40 and 90 degrees of knee flexion) and concentric contraction (30, 60 and 90 degrees per second). Fatigue is evaluated by two self-administered questionnaires: the Fatigue Severity Scale and Modified Fatigue Impact Scale.
2. Effort test:

   The aerobic capacity of patients will be assessed by a triangular maximal exercise test.

   The effort test is performed on a cycle ergometer from a triangular incremental exercise. Beforehand, blood pressure and ECG are recorded to establish that the patient can safely achieve a gradual stress test. Heart rate, blood pressure, oxygen consumption, the feeling (Borg scale) and ECG are recorded immediately before and immediately after the end of the test and every minute for at least 5-10 minutes during the recovery phase.
3. Clinical assessment:

The Timed Up and Go test will be used to assess the patient's capacity of postural transition.

This is a timed quantitative assessment of the duration needed to change from sitting in a chair, get up and walk three meters, make a U-turn and come back to sit down.

The 10 meters test quantifies the walking speed of patients (meters / second) over 10 meters A test of ascending and descending10 stairs is also performed, as well as the 6 minutes walking test.

In addition to these functional assessments, clinical tests are conventionally performed such as the measurement of muscle strength (Medical Research Council scale), range of motion, spasticity (modified Ashworth scale) and an assessment of the balance and posture.

The SEP-59 questionnaire will be used to assess the patients quality of life.

Eligibility criteria: Inclusion Criteria:

* Multiple Sclerosis with EDSS ≤ 6 (Expanded Disability Status Scale)
* Patient ≥ 18 years old
* Patient able to comply with the recommended monitoring
* No relapse within the last three months
* More than six months elapsed since last medical care in day hospital
* No recent modification (six month) of medications for MS
* More than three months elapsed since last change of associated treatments (Fampyra, botulinum toxin)

Exclusion Criteria:

* Patients under any form of guardianship or curatorship
* Breastfeeding
* Orthopedic complications with repercussions on walking activities
* No affiliation to a social security scheme (beneficiary or assignee)

Primary outcomes:
measure: Assessment of the strength and fatigue
timeFrame: Within 10 weeks from the start of the rehabilitation program
Secondary outcomes:
measure: 6 minutes walking test
timeFrame: Within 10 weeks from the start of the rehabilitation program
measure: Evaluation of aerobic capacity during an effort test
timeFrame: Within 10 weeks from the start of the rehabilitation program
measure: Assessment of the balance of patients
timeFrame: Within 10 weeks from the start of the rehabilitation program
measure: Assessment of Spasticity with the Modified Ashworth Scale (MAS),
timeFrame: Within 10 weeks from the start of the rehabilitation program
measure: 10 meters Walk test
timeFrame: Within 10 weeks from the start of the rehabilitation
measure: Timed up and go test
timeFrame: Within 10 weeks from the start of the rehabilitation
measure: Time to ascend and descend stairs
timeFrame: Within 10 weeks from the start of the rehabilitation
measure: Assessment of Strength with the Medical Research Council (MRC),
timeFrame: Within 10 weeks from the start of the rehabilitation
measure: Assessment of Quality of Life with SEP-59 Scale
timeFrame: Within 10 weeks from the start of the rehabilitation
measure: Assessment of the balance of patients
timeFrame: Within 10 weeks from the start of the rehabilitation
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincaré Hospital
Study officials:
affiliation: Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
name: Djamel Bensmail, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: LAMHESS Laboratory, Faculty of Sports Science, 06205 Nice, France
name: Raphael Zory, PhD
role: STUDY_DIRECTOR
affiliation: Physical and Rehabilitation Medicine department, Raymond Poincaré Hospital,
name: Sophie Hameau
role: STUDY_DIRECTOR
References:
citation: Hameau S, Bensmail D, Roche N, Zory R. Fatigability in Patients With Multiple Sclerosis During Maximal Concentric Contractions. Arch Phys Med Rehabil. 2017 Jul;98(7):1339-1347. doi: 10.1016/j.apmr.2016.12.014. Epub 2017 Jan 25.