Multiple Sclerosis Journal - October 2017 - 1528

Multiple Sclerosis Journal 23(11)
is no consensus about treatment for fatigue in MS.
The non-pharmacological (or rehabilitation) therapies
appear to have more significant effects on fatigue
reduction than pharmacological treatments, but evidence is not conclusive.5 However, multidisciplinary
treatment, which often combines multiple different
rehabilitation treatments, has not been shown to be
effective.6,7
Energy conservation management (ECM) is a wellknown strategy for fatigue rehabilitation by occupational therapists.8 ECM involves teaching people to
identify and modify their activities, through systematic
analysis of daily work, home and leisure activities, in
order to reduce the impact of fatigue on daily life.3 The
ECM group programme, with several formats such as
face-to-face, teleconference, self-study modules and
online education, is based on the work of Packer et al.9
and originally addressed the management of fatigue
secondary to chronic illness. The group programme is
effective in MS-related fatigue and quality-of-life
issues at short-term compared to waitlist controls.10-13
Although some studies have shown that beneficial
effects were maintained up to 6 months after treatment,12,14 a systematic review of the available evidence
shows that (randomized) controlled studies have produced little long-term data.15 Also, participation outcomes are lacking in the performed studies.
Furthermore, individual treatment formats are regularly applied in clinical practice, despite the lack of evidence for effectiveness of these approaches.15
This study was designed to investigate the effectiveness of an individual ECM intervention on fatigue
and participation in persons with primary MS-related
fatigue.
Patients and methods
Study design
This study, a single-blind, two-parallel-arm randomized clinical trial (RCT), was performed in two
outpatient rehabilitation departments in the
Netherlands. The study was part of the multi-trial programme Treating Fatigue in MS with Aerobic
Training, Cognitive Behavioural Therapy and Energy
Conservation Management (TREFAMS-ACE),16 in
which the effectiveness of three rehabilitation interventions on fatigue and participation is being evaluated. The protocol used in this study was described in
the study design paper by Beckerman et al.16 The protocol for this study was approved (NL number
33451.029.10; METc VUmc.nr 2010/289) by the
Medical Ethics Committee of the VU University
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Medical Center, Amsterdam, the Netherlands, and
local feasibility statements were obtained from each
participating centre.
Study groups
Experimental intervention: Individual ECM. The protocol was based on the group programme developed
by Packer et al.9 and consisted of 12 sessions by an
occupational therapist over 4 months (Supplement 1).
Information-only control condition consisted of three
MS nurse consultations of 45 minutes each by experienced MS nurses over 4 months (Supplement 2). The
nurses were trained to refrain from providing treatment or treatment advise. Instead, standardized information about MS-related fatigue was provided. The
control group intended to control for attention and
information about fatigue.
The therapists/nurses completed a programme checklist to assess whether each participant and therapist/
nurse adhered to the programme.
Power analysis
The standard sample size calculation was based on
the Checklist Individual Strength (CIS20r) fatigue
subscale. This subscale has been previously used in
studies of MS patients. In all, 45 patients per study
arm were needed to detect a clinically relevant difference of 8 points at the end of treatment on the CIS20r
fatigue subscale, with a standard deviation (SD) of
12.7, with a power of 80%, an alpha of 0.05 and a
maximum attrition rate of 20%.16
Participants
Potential eligible persons with MS were initially
recruited and informed by MS teams (rehabilitation
physicians, MS nurses and neurologists) at the two participating outpatient clinics (Rijndam Rehabilitation
department of Erasmus MC, Rotterdam, and Libra
Rehabilitation Medicine & Audiology, location
Leijpark at Tilburg). A rehabilitation physician checked
the inclusion and exclusion criteria (Table 1). Before
enrolment in the study, all participants provided written
informed consent.
Randomization and masking
Following baseline measurements, the participants
were randomly assigned to ECM or the control group.
The randomization was concealed and computergenerated with a block size of 8 and stratified by
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Table of Contents for the Digital Edition of Multiple Sclerosis Journal - October 2017
