Effects of multidisciplinary paramedic rehabilitation on chronic fatigue in multiple sclerosis: A randomised controlled trial

Completed (inferred)Not a drug-phase studyMS (type not specified)ISRCTN05017507

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main measures

  • 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.

    FatiguePhysical function

Other measures (1)

  • 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 imp

    Thinking and memoryFatigueWalking and mobilityQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

Inclusion: 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: 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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background and study aims Fatigue is a common and disabling symptom in people with multiple sclerosis (MS), and is considered to be one of the main causes of reduced daily activities and quality of life. Due to the multidimensional character of fatigue in MS it seems obvious to manage fatigue in a tailored, multidisciplinary way. To optimize the management of chronic fatigue in MS, a paramedical multidisciplinary rehabilitation program has been developed. The study's findings should help to optimize the management of fatigue in people with MS. Who can participate? The study aims to recruit 48 patients diagnosed with MS and suffering from chronic fatigue. What does the study involve? The patients will be randomly allocated to either receive multidisciplinary rehabilitation or a consultation with the MS nurse. Multidisciplinary rehabilitation consists of occupational therapy, physical therapy or social work or any combination of these treatments. Participants who are allocated to the MS nurse consultation are offered the opportunity to receive multidisciplinary rehabilitation once the study is completed. What are the possible benefits and risks of participating? Both interventions may have a positive effect on dealing with fatigue in MS, of which the effect of multidisciplinary rehabilitation is expected to be larger. Information obtained from this study may be beneficial for future fatigue management of people with MS suffering from fatigue. No harmful effects are expected for either treatment. Where is the study run from? The study was set up by the multidisciplinary care team of the MS centre Amsterdam, VU University Medical Centre Amsterdam. When is the study starting and how long is it expected to run for? Patient were recruited between February 2006 and November 2010. Who is funding the study? Stichting MS Research, Netherlands. Who is the main contact? Dr M. Rietberg, m.rietberg@vumc.nl Professor Dr. G. Kwakkel

Papers

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History

    1. Started

      Feb 2006

    2. Finished

      Nov 2010

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