The primary goal of this trial is to demonstrate that a physical activity program, which consists of an exercise program and follow-up care, under supervision of a specialized physiotherapist can prevent the frequently observed decline in global…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is global cognition, using the Montreal Cognitive
Assessment (MOCA). This test is a frequently used tool to determine cognitive
impaired after a TIA or minor stroke and is more sensitive for cognitive
decline after stroke than the MMSE. Other important cognitive measures will be
assessed in an extensive neuropsychological battery, including tests for
executive function, attention, working memory, and verbal and non-verbal
memory, emphasizing the executive functions. This assessment will be done by a
blinded neuropsychologist.
Cardiorespiratory exercise capacity will be measured with the VO2max test,
which measures the maximal amount of oxygen consumed by an individual's body.
The VO2max will be determined in a maximal exercise test conducted on a cycle
ergometer. This test will be performed in the pulmonary outpatient clinic and
will be evaluated by the pulmonologist and cardiologist.
Secondary outcome
- Physical activity: this variable will be measured by the Physical Activity
Scale for the Elderly (PASE) questionnaire. This questionnaire has been
validated for elderly patients, also in the Netherlands. The score ranges from
0 to 400. The questionnaire consists of 12 items, asking about the frequency
(per week) and the amount of time the patient spends on a certain activity.
- Fatigue: Fatigue Severity Scale
- Depression and anxiety: Hospital Anxiety and Depression Scale
- Cognitive complaints measured by the Cognitive Failure Questionnaire, to
investigate the relationship between complaints of the patients and the
findings in the neuropsychological examination.
- Cardiovascular risk: this combined measure consists of the reached targets
for blood pressure (<140/90 mm Hg) ánd LDL-cholesterol (<2.5 mmol/L) ánd the
use of antithrombotics or oral coagulants in the case of atrial fibrillation.
- Cardiovascular events or mortality: in the 2 year follow up all
cardiovascular events and mortality will be documented.
- Imaging: At baseline all patients will have a CT-scan and MRI-scan of the
brain. The amount of white matter hyperintensities, the amount of lacunar
infarctions and the severity of the atrophy of the hippocampus and precuneus
will be scored.
- Apolipoprotein E *4: in the literature this genetic factor has been linked to
Alzheimer*s disease. This factor may also influence the effect of physical
exercise on cognition and this factor possibly increases the risk of dementia
after stroke. To exclude this factor as a possible confounder we will screen
all patients.
- IQCODE: this is a validated questionnaire to determine cognitive decline
before the TIA or stroke. This questionnaire will be filled out by the partner
or kin of the patients.
Background summary
Patients with transient ischemic attack (TIA) or minor stroke have a high risk
of recurrent stroke, myocardial infarction and death from vascular causes. In
addition, they also have a high risk of cognitive decline and development of
dementia. In several prospective trials 10% percent of patients developed
dementia. However, the percentage of patients with mild cognitive impairment is
even higher en varies between 30% and 70% depending on the criteria used.
Patients with mild cognitive impairment have a higher risk of developing
dementia, but the cognitive impairment can also remain stable or improve. Until
now no intervention has been developed that can prevent cognitive decline after
a TIA or stroke.
The majority of the patients after a TIA or stroke are physical inactive. In
patients with coronary artery disease a cardiac rehabilitation program, which
includes an exercise program decreases mortality. Despite the fact that
patients after a TIA or stroke share the same risk factors, an exercise program
for stroke patients has not been implemented yet. Apart from the possible
positive effect of the exercise program on mortality in these patients, there
are also strong indications for a positive effect on cognition. In the healthy
population physical activity and an exercise program have a positive effect on
cognition. The effect of an exercise program on cognition has not been
investigated in patients after TIA or minor stroke before.
Study objective
The primary goal of this trial is to demonstrate that a physical activity
program, which consists of an exercise program and follow-up care, under
supervision of a specialized physiotherapist can prevent the frequently
observed decline in global cognitive functioning in patients after TIA or minor
stroke. Secondly, we want to investigate if a physical activity program
improves the exercise capacity of patients after a TIA or minor stroke, in the
short and long term.
Study design
We propose to perform a single-blind, randomized controlled single centre trial
with an inclusion period of 1 year and a follow-up period of 1 year, with a
second assessment at 2 years. All patients, who have recently suffered a TIA or
minor stroke and meet the inclusion and exclusion criteria, will be asked to
participate in the study. 120 patients will be included. Patients will be
randomly assigned to group A, the control group, who will receive the standard
care and group B, who are offered a physical activity program. Patients in
group B will participate in a physical activity program, which consists of an
aerobic exercise program of 12 weeks and follow-up care under supervision of a
physiotherapist. Outcome measures for all groups will be assessed at baseline
and after 12 and 24 months of follow-up. This assessment consists of a
neuropsychological assessment, a maximal exercise test, filling out
questionnaires about physical activity, fatigue, depression and cognitive
functioning, a venipuncture to measure the cholesterol level and a blood
pressure measurement.
Intervention
Patients in group A, the control group, will not participate in an intervention
and will only receive standard care. Patients in group B will participate in a
physical activity program, which consists of an aerobic exercise program of 12
weeks and follow-up care by a physiotherapist. The exercise program consists of
aerobic exercise and strength training, 2 times per week during 12 weeks. In
week 2 of the exercise program patients will also start with 30-minute
exercises 3 times per week at home. After the exercise program the patient will
be seen in a follow-up care program by the physiotherapist at 6, 9 and 12
months after inclusion to maintain an active lifestyle.
Study burden and risks
Outcome measures will be assessed on 3 occasions during the two 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 cardiac
checklist with the patient, which has been developed and tested in an earlier
pilot study. If necessary, the patient will be seen by the cardiologist prior
to performing the test. There is always a pulmonary laboratory worker present
who is trained in recognizing 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.
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Listed location countries
Age
Inclusion criteria
Patients older than 18 years with a transient ischemic attack (TIA) or minor stroke less than 1 month ago
National Institute of Health (NIH) stroke scale < 4
Discharge to home without rehabilitation
Able to walk independently (if necessary with walking aid) and make transfers independently
Exclusion criteria
Severe aphasia or language barrier
(Cardiac or pulmonary) Contraindications for physical activity
Disease with assumed inability to perform physical activity
Dementia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL38008.029.11 |
| OMON | NL-OMON21582 |