Lifebalance; an important outcome for fatigue management in neuromuscular diseases

About 60% of persons with neuromuscular diseases (NMD) experiences chronic
fatigue. Fatigue management programs, like the occupational therapy program
*Managing Fatigue* support persons to plan, pace and prioritize activities and
to find a balance in activities in daily life. A group intervention on managing
fatigue has been developed and tested in different populations including
multiple sclerosis. However, not everyone has access to such a group program.
Recent studies on a one-to-one fatigue management courses have shown mixed
results, but have merely been tested among people with MS. There are no studies
available for individual *Managing fatigue* programs for people with
neuromuscular diseases (NMD) such as facioscapulohumeral dystrophy (FSHD) or
mitochondrial myopathy (MM).

Primary objective: To evaluate effectiveness, directly after intervention, of
an individual face to face Managing Fatigue program on participation for people
with NMD, including FSHD or MM compared to a control group receiving usual care.
Secondary objectives:
To evaluate effectiveness, directly after intervention, of an individual face
to face Managing Fatigue program on participation, fatigue, life balance and
quality of life for people with FSHD or MM compared to a control group
receiving usual care.
To evaluate the effectiveness, at six and twelve months after baseline of an
individual face to face Managing Fatigue program on participation, fatigue,
life balance and quality of life for people with NMD, including FSHD or MM
compared to a control group receiving usual care.

Study design A randomised clinical trial (RCT) will be conducted comparing the
personalized, individual face-to-face program Managing Fatigue (next to usual
care) with a control group receiving usual care excluding occupational therapy.

The individualized one-to-one face-to-face program, MF, consists of education,
practice, evaluation and implementation of energy conservation strategies in
daily life. Following education, persons are invited to gain experience with
the strategies and discuss the successes and barriers experienced. Whereas this
intervention was originally developed as a group intervention, in the Life
Balance Study (Libas) this intervention will be delivered as a individual face
to face intervention, delivered by occupational therapists in primary care.

Burden and risks for the participants Participants in the intervention group
(n=30) will receive 6-10 sessions of the Managing Fatigue program. This program
will be delivered individually face-to-face by an occupational therapist in the
patients* own environment. The intervention includes education, practice and
homework assignments. The thirty participants in the control group will receive
care as usual, but no occupational therapy during the time of the study. All
participants will complete the outcome measures at four measurement moments: at
baseline (before the intervention), and at three, six and twelve months after
baseline (post intervention). The measurements will take place at the
participants* home by interview (estimated time for each interview 2 hours) and
by mailed questionnaires (digital or paper, estimated time is 45 minutes per
measurement moment). There are no medical risks involved.