Effectiveness of cognitive and graded activity training (COGRAT) on post stroke fatigue. A multi-center study.

Stroke patients frequently complain of excessive fatigue, both in post-acute
and in the chronic stage of their illness. This complaint is one of the major
problems encountered in clinical practice and recent studies have confirmed
thes clinical impressions: Post Stroke Fatigue (PSF) is ferquently reported
after stroke, even by patients who seem to recover well, and it may lead to
several impairments in daily functioning. Although clinicians are aware that a
treament for PSF is urgently needed, there are almost no standardized
treatmenst available, neither in Dutch hospitals, nor in rehabilitation
centers. An exception is the Day Clinic for Brain Injury of the Sint
Maartenskliniek in Nijmegen.
In this group intervention (6 to 7 patients per group), cognitive strategy
trainig is combined with an individual graded activity program.
In a recent pilot-study the effectiveness of this combined approach has been
investigated in 23 trained stroke patients, with effects beyound expectation.
However, a well designed, prospective study of COGRAT is still lacking.

Therefore the present study is aimed at answering the following question: does
cognitive and graded activity training (COGRAT) lead to a clinically
significant reduction of subjective fatigue complaints in stroke patients, when
compared with cognitive training alone and with a no-treatment condition? Is
this effect still present 6 months after training?
Secondary questions are:
1. is the reduction of fatigue complaints coupled to an improvement of physical
activity in the trained group?
2. Is the reduction of fatigue complaints accompanied by a decrease of
cognitive impairments in the fields of attention and memory, as measured by
neuropsychological tests and as experienced by the patients?
3. Can (a) the level of initial physical activity, (b) the severity of the
initial cognitive impairments, and (c) post onset time, significantly predict
the effects of COGRAT treatment?

In a multi-center trial 96 stroke patients will participate in this study. Each
patient will be submitted to a first measurement at admission. Then, every
patient will be placed on a waiting list for three months (the so-called
qualification period)and a second measurement will take place, just before
random assignment to one out of two treatment conditions: (a) the full COGRAT
training, (b) the cognitive part of COGRAT only. At the end of treatment, and 6
months after the end of treatment (follow-up) every participant will be
assessed again.

In this study patients will be given Cognitive trategy training for 12 weeks,
depdending on the treatment condition accompanied by the Graded Activity
training.

Compared withe the original treatment, COGRAT will be modified on the following
points:
A. The cognitive strategy intervention will be extended with cognitive and
behavioral strategies aimed at dealing more effectively with present fatigue,
instead of offering only fatigue avoidance strategies.
B. Graded Acitvity will be better structured, by describing it in a protocol
and basing it on the Exercise Programming Recommentdations for Stroke Survivors
of the American Heart Association.
C. Based on the experience gathered in the pilot study, in which patients with
information processing deficiencies derived less benefit from COGRAT, group
size in the cognitive intervention will be limited to 4.

Patients will be asked to be placed on a waiting list for 3 months. They are
tested on 4 different moments. The tests will consist of: walking with an
acotmeter for a time period of one week, to establish actual taken steps per
minute; questionnaires on social functioning and attributions, and
neuropsychological tests to measure attention, concentration and memory.
We do not expect any risks in involving this project.