Condition category
Nervous System Diseases
Date applied
10/07/2013
Date assigned
05/08/2013
Last edited
19/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gert Kwakkel

ORCID ID

Contact details

Department of Rehabilitation Medicine
VU University Medical Center
Amsterdam
1081 HV
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04-553 MS

Study information

Scientific title

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

Acronym

TOF

Study hypothesis

It is hypothesized that individually tailored, multidisciplinary outpatient rehabilitation by paramedical disciplines is more effective in reducing MS related chronic fatigue than consultation by an MS-nurse alone.

Ethics approval

The RCT was approved by the ethics committee of the VU University Medical Centre, Amsterdam (METc VUmc). Registration number 2005/72. date 12-05-2005

Study design

Single centre single blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please contact m.rietberg@vumc.nl to request a patient information sheet

Condition

Multiple sclerosis, fatigue

Intervention

Multidisciplinary paramedical rehabilitation.
Patients assigned to multidisciplinary rehabilitation receive either occupational therapy, physical therapy or social work or any combination of these treatments. The participating disciplines treat MS-related fatigue according to specific treatment programmes.

MS-Nurse consultation
Patients allocated to the control group receive MS–nurse consultation based on the Nursing Intervention Classification (NIC)

Double baseline assessment at week -1 and week 0, one assessment post intervention at 12 weeks and a follow-up assessment at 24 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome 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.

Secondary outcome measures

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 problems for every aspect of participation, reflected in 8 problem experience scores (mobility, selfcare, activities around the house, looking after money, leisure, social life and relations, helping and supporting other people, paid for voluntary work, education and training).

All measures were assessed at baseline, 12 weeks and 24 weeks

Overall trial start date

01/02/2006

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant 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

Recruitment start date

01/02/2006

Recruitment end date

01/11/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Rehabilitation Medicine
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

Stichting MS Research (Netherlands)

Sponsor details

Leidseweg 557
Voorschoten
2250 AE
Netherlands
onderzoek@msresearch.nl

Sponsor type

Research organisation

Website

http://msresearch.nl/

Funders

Funder type

Research organisation

Funder name

Stichting MS Research (Netherlands) (project number 04-553 MS)

Alternative name(s)

Dutch Multiple Sclerosis Research Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25232955

Publication citations

  1. Results

    Rietberg MB, van Wegen EE, Eyssen IC, Kwakkel G, , Effects of multidisciplinary rehabilitation on chronic fatigue in multiple sclerosis: a randomized controlled trial., PLoS ONE, 2014, 9, 9, e107710, doi: 10.1371/journal.pone.0107710.

Additional files

Editorial Notes