Condition category
Nervous System Diseases
Date applied
13/07/2011
Date assigned
19/07/2011
Last edited
11/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heleen Beckerman

ORCID ID

Contact details

Dept Rehabilitation Medicine
VU University Medical Center
PO Box 7057
Amsterdam
1007 MB
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw 60-61300-98-024; CCMO NL33451.029.10

Study information

Scientific title

Disabling fatigue in multiple sclerosis occurs frequently: how should it be treated? A randomized clinical trial

Acronym

TREFAMS-E

Study hypothesis

What is the effect of Energy Conservation Management (ECM) advices on fatigue and participation in patients with Multiple Sclerosis? Can this effect be attributed to the use of ergonomic advices given or adhering to altered time-schedules?

Ethics approval

1. The Medical Ethics Committee of the VU University Medical Center (2010/289), 05/04/2011
2. The Board of the Erasmus Medical Center Rotterdam, 27/06/2011

Study design

Randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multiple Sclerosis

Intervention

1. Energy Conservation Management consists of 12 individual therapist-supervised 45-minute sessions, in which energy-management and ergonomic advices are given, in a period of 4 months; in the first 8 weeks one occupational therapist-supervised session will be given per week, in the subsequent 8 weeks one therapist-supervised session will be given every other week. In addition, individualized home-assignments are given.
2. Control treatment for each RCT of the TREFAMS-ACE research programme consists of currently available standardized written patient information and will be provided in a standardized manner by an MS nurse. Patients receive this information package personally in the first week. In week 6 and 16, 45-minute appointments with the MS nurse will be scheduled in order to ask questions about the information package. This control treatment covers two important aspects that we want to control for:
2.1. Good information about MS related fatigue, and
2.2. Attention of a professional who has experience in MS in order to reassure the patient that his concerns or questions will be taken seriously. The MS nurses will receive instructions on how to provide the information without additional therapeutic interventions or specific personal advises

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Fatigue: Checklist Individual Strength (CIS) subscale fatigue
2. Participation: Impact on Participation and Autonomy (IPA)
The 6 time points are: week-1, week 0, week 8, week 16, week 26 and week 52

Secondary outcome measures

1. Medical Outcome study Short Form 36 (SF36)
2. Rehabilitation Activities Profile (RAP)
3. Fatigue Severity Scale (FSS)
4. Checklist Individual Strength (CIS) subscales motivation, concentration, activity
5. Modified Fatigue Impact Scale (MFIS)
The 6 time points are: week -1, week 0, week 8, week 16, week 26 and week 52

Overall trial start date

15/09/2011

Overall trial end date

01/04/2014

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Patients using in the last three months prior to inclusion amantadine, modafinil, RitalinĀ® or pemoline for their fatigue
2. Major depression

Recruitment start date

15/09/2011

Recruitment end date

01/04/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Center (Netherlands)

Sponsor details

Dept Rehabilitation Medicine
PO Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.com/patientcare/

Funders

Funder type

Government

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ZonMw 60-61300-98-024)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fonds NutsOhra (Netherlands)

Alternative name(s)

Stichting Nuts Ohra, NutsOhra Foundation, NutsOhra Fund

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23938046
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25239283

Publication citations

  1. Protocol

    Beckerman H, Blikman LJ, Heine M, Malekzadeh A, Teunissen CE, Bussmann JB, Kwakkel G, van Meeteren J, de Groot V, , The effectiveness of aerobic training, cognitive behavioural therapy, and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme., Trials, 2013, 14, 250, doi: 10.1186/1745-6215-14-250.

  2. Results

    Blikman LJ, van Meeteren J, Horemans HL, Kortenhorst IC, Beckerman H, Stam HJ, Bussmann JB, Is physical behavior affected in fatigued persons with multiple sclerosis?, Arch Phys Med Rehabil, 2015, 96, 1, 24-29, doi: 10.1016/j.apmr.2014.08.023.

Additional files

Editorial Notes