MotiveS and MoveIT: chronic, multidisciplinary post-stroke care and aerobic exercise after transient ischemic attack or minor stroke - a pilot study

Patients with transient ischemic attack (TIA) or minor stroke have a high risk
of recurrent stroke, myocardial infarction and death from vascular causes. It
is thought that this risk can be decreased up to 80% by treatment with
antithrombotics, antihypertensiva and statins, and addressing life style
factors such as cessation of smoking and alcohol consumption, loosing weight
and improving physical activity. However, neurovascular care in the Netherlands
is dominated by acute stroke care. Chronic care for ambulatory stroke survivors
is highly variable, and generally less well organized. In a survey by the Dutch
Heart association in 2006 only 62% of ambulatory stroke survivors with raised
blood pressure used an antihypertensive agent, and only 52% of patients with
hypercholesterolemia received statins. Improving adherence to guidelines and
lifestyle changes by standardized chronic poststroke care might be a powerful
way to increase efficiency of secondary stroke prevention, but this has not
been investigated before. Moreover, a cardiac rehabilitation program, which was
developed to influence lifestyle factors and improve physical activity,
decreases mortality in patients with coronary artery disease. This has not been
implemented for stroke, while patients share the same risk factors. After
stroke patients have a higher chance of cognitive deterioration and developing
dementia. In the healthy population physical activity has a positive effect on
cognition. The effect of a physical activity program on cognition in patients
with a TIA or minor stroke has not been investigated before.

1. To investigate whether a single-blind, randomized controlled trial in
patients with a TIA or minor stroke addressing secondary prevention, healthy
life style and cognition is feasible and not too demanding for the patient.
2. To investigate whether a multidisciplinary poststroke care program has a
positive effect on achieving adequate secondary prevention and achieving and
maintaining an active and healthy lifestyle in patients after TIA or minor
stroke.
3. To investigate whether an exercise program under supervision of a
physiotherapist and multidisciplinary poststroke care program , will improve
physical activity, promote adequate secondary prevention and an active and
healthy lifestyle in patients with a TIA or minor stroke.
4. To investigate whether increased physical activity decreases cognitive
impairment in patients after TIA or minor stroke.
We expect to only achieve our first goal in this pilot. For the other goals we
only expect to demonstrate a non-significant improvement in the intervention
group in comparison to the control group. If this pilot proves to be feasible
and not too demanding for the patient we will start a larger trial with
sufficient power to achieve the other goals.

We propose a single-blind, randomized controlled single centre pilot trial with
an inclusion period of 3 months and a follow-up period of 1 year. Patients, who
have recently suffered a TIA or minor stroke, will be asked to participate in
the study. 20 patients will be included. Patients will be randomly assigned to
two intervention groups; group A, a multidisciplinary chronic poststroke care
during one year and group B, a combined multidisciplinary poststroke care
program and a physical activity program. Patients in group A and B will be seen
in the outpatient clinic at least every 3 months. Patients in group B will also
participate in a physical activity program, which consists of an aerobic
exercise program of 8 weeks and follow-up care under supervision of a
physiotherapist.
Outcome measures for all groups will be assessed at baseline 4 weeks after the
event and after 3 and 12 months follow-up. This assessment consists of filling
out questionnaires about physical activity, medication adherence, quality of
life, fatigue, depression and satisfaction with care, a venipuncture to measure
the cholesterol level, a blood pressure measurement, a neuropsychological
assessment, a maximal exercise test and physiotherapy assessment.

Patients in group A and B will be seen in the outpatients clinic regularly.
These appointments are multidisciplinary with participation of physicians,
stroke-nurses, physiotherapists and dietitians. The goal of these appointments
are optimising secondary prevention by adjustment of medication and promoting a
healthy lifestyle. Medication adjustment will be done by a neurologist (in
training), using a stepwise protocol. During these visits an active
participation of the patient is requested and selfmanagement will be promoted.
To promote selfmanagement we will use the 'motivational interviewing' method, a
patient directed, directive method which increases the intrinsic motivation for
behaviour change by exploring and solving ambivalence. Patients will visit the
outpatient clinic 4 and 12 weeks and 6, 9 and 12 months after the event.
Patients in group B will also participate in a physical activity program, which
consists of an aerobic exercise program of 8 weeks and follow-up care by
physiotherapist. The exercise program consists of aerobic exercise and strength
training, 3 times per week during 8 weeks. After this program the patient will
be seen in a follow-up care program by the physiotherapist to maintain an
active lifestyle. Patients will be seen by a cardiologist and pulmonologist
prior to starting with the physical activity program to exclude cardiac and
pulmonary contraindications.

Outcome measures will be assessed on three occasions during the one year
follow-up. These assessments will cost the patient 15 hours overall. The
outcome measures assessed in patients are relevant to the disorder of the
patient and the interventions. The venipuncture is necessary to measure
cholesterol and we will send the results to the general physician to prevent an
unnecessary venipuncture. The VO2max measurement in a maximal exercise test is
necessary to demonstrate the effect of the physical activity program on the
cardiorespiratory exercise capacity of the patient. A maximal exercise test has
a certain risk, particularly in patients who are not used to perform physical
activity. In patients with latent cardiac disease a maximal exercise test can
provoke cardiac complaints. Before this test we will always fill out a
cardiopulmonary checklist with the patient. If necessary the patient will be
seen by the cardiologist and pulmonologist prior to performing the test. There
is always a pulmonary laboratory worker present who is trained in recognising
ECG-abnormalities or other reasons for terminating the test prematurely. A
pulmonologist is available in case of medical calamities. The maximal exercise
test is also necessary to determine the intensity of the exercise program by
using percentages of the maximal heart rate and load.