Multiple sclerosis, fatigue Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 years, either sex 2. Diagnosed with MS according to the criteria of McDonald [Mc Donald 2001] and 3. Suffering from chronic fatigue. Chronic fatigue was defined as ?being present for any amount of time on at least 50 percent of the days, for more than 6 weeks? as agreed on by the Multiple Sclerosis Council for Clinical Practice Guidelines.
Exclusion criteria
Exclusion criteria: Patients were excluded in case of: 1. Current MS relapse 2. Pregnancy 3. Current inflammation (cystitis) 4. Alcohol or substance abuse 5. Physical conditions like muscle spasm or pain, or 6. Depressive symptomatology importantly contributing to fatigue
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue assessed using the self report questionnaire Checklist individual strength (CIS-20R): 20 statements for which the participant has to indicate on a 7 point scale ranging from ?Yes, that is true? to ?No, that is not true? to what extent the particular statement applies to him or her, at baseline, 12 weeks and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Modified Fatigue Impact Scale (MFIS): assesses the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning during the past 4 weeks. Participants rate on a 5-point Likert scale, ranging from ?Never? to ?Almost always?, their agreement with 21 statements. 2. Fatigue Severity Scale (FSS): a nine-item questionnaire to assess the severity of fatigue and its impact on an individual?s daily functioning using a seven-point rating scale. Participants rate their agreement with a statement ranging from one point, reflecting ?strongly disagree? to seven points representing ?strongly agree?, depending on how appropriate they feel the statement applies to them 3. Functional Independence Measure (FIM): measures activities of daily living. It is an 18-item, generic seven-point rating scale to assess physical and cognitive disability in terms of burden of care. 4. Disability and Impact Profile (DIP): is a 39 item self-administered questionnaire regarding activities that may be restricted by a disabling disease. Each item is rated on a 0-10 point scale for its current disability and for the importance of that disability 5. Multiple Sclerosis Impact Scale (MSIS-29): disease-specific measure of the physical (20 items) and psychological (9 items) impact of MS from the patient?s perspective. The self-reported instrument measures disease impact due to limitations in the past 2 weeks, scored on 5 levels from ??not at all?? to ??extremely.?? Scores on the individual items are added and then transformed to a 0?100 scale, thereby generating two summary scores (for physical and psychological impact). 6. Impact on Participation and Autonomy (IPA): measures person-perceived participation. The IPA is a generic questionnaire that addresses 2 different aspects of participation: (1) perceived participation, reflected in 31 items in 5 domains (interior and exterior autonomy, family role, social relations and job and education) , and (2) the experience of p | — |
Countries
Netherlands