The efficacy of cognitive behavior therapy and aerobic exercise training for decreasing experienced fatigue in patients with facioscapulohumeral dystrophy.

In facioscapulohumeral dystrophy (FSHD) muscle function is impaired and
declines over time. Currently there is no effective therapeutic treatment
available for FSHD. Loss of muscle strength contributes to experienced fatigue
through a lower level of physical activity. Fatigue and physical inactivity
determine social dependency and loss of participation. Therefore, to decrease
experienced fatigue and improve quality of life, two distinctly different
therapeutic approaches can be followed: aerobic exercise training (AET) to
maintain functional capacity or a cognitive-behavioral approach (CBT) to
stimulate an active life-style yet avoiding excessive physical strain. There is
preliminary evidence for the effectiveness of aerobic exercise in FSHD. CBT has
been proven effective in chronic fatigue syndrome and post-cancer fatigue. AET
and CBT are hypothesized to be both more effective in improving activity level
and, with that, decreasing experienced fatigue of FSHD patients compared to the
usual care. The maintenance of the beneficial effects of CBT may be longer than
those of AET, because the changes in activity level are achieved more
intrinsically.

The primary objective is to study the efficacy of AET and CBT in decreasing
experienced fatigue in patients with FSHD. Secondary objectives are (1) to
identify generic and disease-specific determinants of effects, (2) to evaluate
the effect of CBT and AET in reducing fall incidence, (3) to obtain insight
into patients* expectations of, and experiences with both interventions and
compare these with health care professionals* views and experiences.

a randomized controlled trial.

one group will receive AET consisting of 3 days a week aerobic cycling exercise
for a period of 16 weeks. Twice a week they will exercise at home and once a
week individually guided in group sessions in a rehabilitation centre. The
second group will receive a maximum number of 16 sessions of CBT during 16
weeks for treatment of the factors maintaining the fatigue. The third group
will receive care as usual, for 16 weeks and will be placed on a waiting list.
They will be randomized to one of the training groups after 7 months.

There are very little risks associated with participation, as none of the
interventions or clinical measurements are invasive. The proposed tehrapies
have little to none known side-effects. The safety standards for training are
strictly followed.