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, Ritalin® 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
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
-
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.
-
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.