TREating FAtigue in Multiple Sclerosis: Energy conservation management

ISRCTN	ISRCTN82353628
DOI	https://doi.org/10.1186/ISRCTN82353628
Protocol serial number	ZonMw 60-61300-98-024; CCMO NL33451.029.10
Sponsor	VU University Medical Center (Netherlands)
Funders	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ZonMw 60-61300-98-024), Fonds NutsOhra (Netherlands)

Submission date: 13/07/2011
Registration date: 19/07/2011
Last edited: 11/03/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Heleen Beckerman
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomized clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Disabling fatigue in multiple sclerosis occurs frequently: how should it be treated? A randomized clinical trial
Study acronym	TREFAMS-E
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	90
Key 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)
Key exclusion criteria	1. Patients using in the last three months prior to inclusion amantadine, modafinil, Ritalin® or pemoline for their fatigue 2. Major depression
Date of first enrolment	15/09/2011
Date of final enrolment	01/04/2014

Locations

Countries of recruitment

Netherlands

Study participating centre

VU University Medical Center

Amsterdam
1007 MB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2015		Yes	No
Protocol article	protocol	12/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes