No registrations found.
ID
Source
Brief title
Health condition
stroke
TIA
physical exercise
beroerte
lichaamsbeweging
Sponsors and support
Stichting Roomsch Catholijk Oude Armen Kantoor
Intervention
Outcome measures
Primary outcome
1. The primary outcome measure is global cognition, using the Montreal Cognitive Assessment (MOCA). 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;
2. Cardiorespiratory exercise capacity will be measured with the VO2max test, which measures the maximal amount of oxygen consumed by an individual's body.
Secondary outcome
1. Physical activity measured by the Physical Activity Scale for the Elderly (PASE) questionnaire;
2. Fatigue assessed by means of the Fatigue Severity Scale;
3. Depression and anxiety by means of the Hospital Anxiety and Depression Scale;
4. Cognitive complaints measured by the Cognitive Failure Questionnaire;
5. 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;
6. Cardiovascular events or mortality: in the 2 year follow up all cardiovascular events and mortality will be documented.
Background summary
This study is a single-blind, randomized controlled single centre trial with an inclusion period of 1.5 year and a follow-up period of 1 year, with a second assessment at 2 years. All patients, who have recently suffered from 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. After informed consent, patients will be randomly assigned to the control group, who will receive standard care, or the physical activity program. The physical activity program 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.
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.
Study design
Outcome measures for all groups will be assessed at baseline and after 12 and 24 months of follow-up.
Intervention
After informed consent, patients will be randomly assigned to the control group, who will receive standard care, or the physical activity program.
The physical activity program 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.
R.M. Berg-Vos, van den
Amsterdam 1061 AE
The Netherlands
+31 (0)20 5108780
r.vandenberg-vos@slaz.nl
R.M. Berg-Vos, van den
Amsterdam 1061 AE
The Netherlands
+31 (0)20 5108780
r.vandenberg-vos@slaz.nl
Inclusion criteria
1. Patients older than 18 years with a transient ischemic attack (TIA) or minor stroke less than 1 month ago;
2. National Institute of Health (NIH) stroke scale < 4;
3. Discharge to home without rehabilitation;
4. Able to walk independently (if necessary with walking aid) and make transfers independently.
Exclusion criteria
1. Severe aphasia or language barrier;
2. (Cardiac or pulmonary) contraindications for physical activity;
3. Disease with assumed inability to perform physical activity;
4. Dementia.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3721 |
| NTR-old | NTR3884 |
| CCMO | NL38008.029.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39313 |