TREating FAtigue in Multiple Sclerosis: Energy conservation management
Completed
- Conditions
- Multiple SclerosisNervous System Diseases
- Registration Number
- ISRCTN82353628
- Lead Sponsor
- VU University Medical Center (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Ambulatory multiple sclerosis (MS) patients fulfulling the following enrollment criteria:
1. Age between 18-70 years
2. Diagnosis of MS according to the criteria of McDonald
3. Able to walk with no more than one unilateral walking aid i.e. able to walk with no more than one unilateral walking aid
4. Suffering from fatigue, defined as a score higher than 35 on the subscale fatigue of the Checklist Individual Strength (CIS)
Exclusion Criteria
1. Patients using in the last three months prior to inclusion amantadine, modafinil, Ritalin®
or pemoline for their fatigue
2. Major depression
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Fatigue: Checklist Individual Strength (CIS) subscale fatigue <br>2. Participation: Impact on Participation and Autonomy (IPA) <br>The 6 time points are: week-1, week 0, week 8, week 16, week 26 and week 52
- Secondary Outcome Measures
Name Time Method 1. Medical Outcome study Short Form 36 (SF36) <br>2. Rehabilitation Activities Profile (RAP) <br>3. Fatigue Severity Scale (FSS) <br>4. Checklist Individual Strength (CIS) subscales motivation, concentration, activity <br>5. Modified Fatigue Impact Scale (MFIS) <br>The 6 time points are: week-1, week 0, week 8, week 16, week 26 and week 52