Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132483
Status:
COMPLETED
Last Update Posted:
2007-10-22
First Post:
2005-08-19
Brief Title:
ExStroke Pilot Trial Physical Exercise After Acute Ischaemic Stroke
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Summary
This study will look at physical exercise after acute ischaemic stroke It is called the ExStroke Pilot Trial
Physical activity is associated with a lower risk of first-time stroke It remains unknown if physical activity also is associated with a lower risk of recurrent stroke Patients with ischaemic stroke have a 30 to 40 risk of a recurrent stroke during a 5 year follow-up The risk of acute myocardial infarction MI and death from vascular disease is approximately 15 each The impact of lifestyle factors on risk for these events is insufficiently covered in the international scientific literature
Purpose
The purpose of the trial is to examine whether the level of physical activity increases in patients who have had an ischemic stroke when they are informed about physical activity and instructed in a physical training program The occurrence of new cerebro- and cardiovascular events in the patients will be registered The patients are randomised to receive oral and written information by a physician and a physiotherapist about physical exercise or to a control group with no instruction regarding physical exercise Both groups will receive the best available therapy with regard to secondary stroke prevention and will be informed about lifestyle factors
Irrespective of which group the patients are randomised to all patients will receive the best possible established treatment with regard to prevention of thromboses blood pressure control lipid lowering agents if necessary and information about diet tobacco smoking and vitamin supplements
Study Design
The patients will be randomised centrally within 90 days after stroke onset and they will be re-examined at 3 6 9 12 18 and 24 months Inclusion criteria are patients with ischaemic stroke aged 40 years or older In the pilot trial a number of 300 included patients is wanted
This study will look at physical exercise after acute ischaemic stroke It is called the ExStroke Pilot Trial
Physical activity is associated with a lower risk of first-time stroke It remains unknown if physical activity also is associated with a lower risk of recurrent stroke Patients with ischaemic stroke have a 30 to 40 risk of a recurrent stroke during a 5 year follow-up The risk of acute myocardial infarction MI and death from vascular disease is approximately 15 each The impact of lifestyle factors on risk for these events is insufficiently covered in the international scientific literature
Purpose
The purpose of the trial is to examine whether the level of physical activity increases in patients who have had an ischemic stroke when they are informed about physical activity and instructed in a physical training program The occurrence of new cerebro- and cardiovascular events in the patients will be registered The patients are randomised to receive oral and written information by a physician and a physiotherapist about physical exercise or to a control group with no instruction regarding physical exercise Both groups will receive the best available therapy with regard to secondary stroke prevention and will be informed about lifestyle factors
Irrespective of which group the patients are randomised to all patients will receive the best possible established treatment with regard to prevention of thromboses blood pressure control lipid lowering agents if necessary and information about diet tobacco smoking and vitamin supplements
Study Design
The patients will be randomised centrally within 90 days after stroke onset and they will be re-examined at 3 6 9 12 18 and 24 months Inclusion criteria are patients with ischaemic stroke aged 40 years or older In the pilot trial a number of 300 included patients is wanted
Detailed Description:
Physical exercise after acute ischaemic stroke
The ExStroke Pilot Trial
A randomised clinical trial
Investigation group
Principal investigator
Gudrun Boysen Professor DMSc Department of Neurology Bispebjerg University Hospital
Co-investigators
2400 Copenhagen NV
Anders Pedersen Project Nurse
Lars-Henrik Krarup MD
Thomas Truelsen MD PhD
Lotte Hansen Physiotherapist
Marianne Lindahl Physiotherapist
Christian Gluud DMSc Copenhagen Trial Unit Rigshospitalet 2100 Copenhagen Ø
Introduction
Physical activity is associated with a lower risk of first-time stroke It is unknown if physical exercise reduces risk of recurrent stroke Clinicians treating stroke patients are inevitably confronted with the question of how to reduce the risk of a second stroke In addition to the risk of recurrent stroke a stroke survivor is also at risk of suffering acute myocardial infarction MI and other cardiovascular complications Efforts to reduce cardiovascular risk may potentially also reduce stroke risk
Physical activity as contrasted to sedentary lifestyle is associated with a reduced risk of first stroke but in one of these studies the reduction in stroke risk did not reach statistical significance In a Norwegian study the relative risk of stroke mortality was 056 95 confidence interval CI 036 - 088 in physically active women aged 70-79 years compared to women with lower physical activity
Purpose of the ExStroke Trial
To evaluate the effect of instruction in physical training on Physical Activity Scale for Elderly PASEin patients with ischemic stroke
Other endpoints are recurrent stroke MI death of all causes and vascular death after an ischaemic stroke in patients randomised to receive verbal instruction by a stroke physiciana neurologist and a physiotherapist concurrently with written information on physical exercise versus a control group which is to receive standard information on the usefulness of physical activity Both groups will receive physiotherapy according to the usual standards of the department to which the patients are admitted
The Interventions
Physical exercise after discharge from hospital
Patients randomised to the physical exercise group shall have a session with a stroke physiciana neurologist and a physiotherapist in which the patients possibilities and wishes of training activity after discharge are discussed In agreement with the patient a training program is designed for the individual patient according to the patients resources and capability The training program on which the patient the physician and the physiotherapist have agreed must be written down the patient will keep a copy of the training program another copy is kept in the patient files and a third copy is kept in Clinical Record Form CRF
At the follow-up visits the level of physical activity is evaluated using the Physical Activity Scale in the Elderly PASE in both groups and the Copenhagen City Heart Study questionnaire on physical activity
It is recommended that patients in the active group should be contacted between the follow-up sessions by the physiotherapist in order to stimulate physical exercise Patients in the control group shall receive the same high quality medical care but without further discussion of physical training unless the patient requests such information
Hypotheses
Several studies have shown that a certain amount of physical activity is associated with reduced risk of first-ever stroke It is hypothesised that a certain level of physical exercise in patients with ischaemic stroke will reduce the risk of subsequent cardio-vascular events The following hypotheses will be tested
Level of physical activity will increase when patients are instructed in a physical training program
The incidence of recurrent stroke MI or death following an ischaemic stroke will be lower in patients who have received verbal and written instruction on physical exercise compared with those in the control group
Outcome Measures
Primary Outcome Measure physical activity as measured by PASE
Secondary Outcome Measure time from randomisation to recurrent stroke or to MI or to death of all causes
Third Outcome Measure time from randomisation to recurrent stroke MI and vascular death
Fourth Outcome Measure frequency of recurrent stroke
Fifth Outcome Measure activities of daily living as measured by modified Rankin Scale
Sixth Outcome Measure quality of life
Seventh Outcome Measure frequency of falls and fractures
Study Design
Consecutive patients meeting all inclusion criteria and none of the exclusion criteria will be asked if they want to participate in the trial Patients will be included as soon as convenient and within 90 days after onset of an ischaemic stroke There will be follow-up sessions at 36 9 12 18 24 months The study is a randomised single blind parallel group multicenter international clinical trial
Informed Consent
Randomisation
The randomisation will be performed centrally with randomisation in blocks 11 stratifying for center sex age and stroke severity The Copenhagen Trial Unit CTU will perform the randomisation
Study Population and Planned Sample Size
Patients with ischaemic stroke being 40 years of age or older will be included in the study It is unknown if level of physical activity can be increased by repeated information given to patients with a stroke Level of physical activity is evaluated according to the PASE scale which is expected to be approximately 70 as a mean value Based on a standard deviation of 50 a minimal relevant difference of 20 in PASE score a Type I error of 5 a Type 2 error of 20 it is estimated that 100 patients should be included in each of the two study arms To take into account withdrawals and dropouts about 50 more patients should be included in each arm giving a total of 300 patients in the pilot trial
Inclusion Criteria
Subjects aged 40 years or older
Patients with a clinical diagnosis of stroke symptoms lasting 24 hours or more
CT-scan of the brain must either show a new infarct or be normal Patients only with infarcts without clinical symptoms cannot be included
Inclusion shall take place before day 90 after stroke onset
Informed consent after verbal and written information
The patient must be able to walk either unaided or with a cane or a walker
Exclusion Criteria
Patients who are unable to understand the information or who can not cooperate are excluded
Patients confined to a wheelchair or bed
CT-scanning showing intracranial haemorrhage or focal pathology other than infarction cerebral atrophy or leucoaraiosis
Modified Rankin score of 4 or 5 before the actual stroke
Serious medical disease such as AIDS metastatic cancer or abnormalities that the investigator feels may compromise the patients successful participation in the trial
Earlier randomisation in this trial
Baseline Registration
Sex and birthday
Date of qualifying stroke day month year
Type of stroke
Results of CT scan ECG and Doppler examination of carotid arteries shall be obtained
Information on treatment with anti-thrombotic medication and on treatment with anti-hypertensive medication before discharge of the index stroke
Information on blood pressure on inclusion
Weight and height
Adverse Events
Stroke patients are at risk of adverse events such as the occurrence of falls fractures
Follow-Up Visits
Follow-up examinations take place at 3 6 9 12 18 and 24 months after the inclusion of the patient in the trial On each visit the medical history shall include information on date of recurrent stroke date of transient ischaemic attacks TIA date of gastro-intestinal bleeding other bleeding episodes and date of MI falls and fractures and date of any serious adverse events
In case of hospital admissions information on diagnosis and length of stay shall be obtained
In case of death information on date of death shall be retrieved and the cause of death be given as either baseline stroke new stroke cardiac disease vascular causes or other causes
On each follow-up visit the patients randomised to physical exercise group shall have repeated instruction by the physiotherapist as to the exercises suggested at baseline or adapted to the present capability of the patient Such adapted instructions on the training program must be written down The patient shall receive a copy of it a second copy shall be inserted in the patient record and a third copy in the case record form
On each visit in all patients the physical activity scale PASE shall be completed The interview will be done by a co-investigator who is blinded as to what group the patient was randomised
Three Month Follow-Up
Information is recorded on the following items
Scandinavian Stroke Scale
Modified Rankin Scale
Blood pressure
Tobacco smoking
Alcohol consumption
Antithrombotic medication
Antihypertensive medication
PASE form
Events such as recurrent stroke MI or adverse events are recorded
Quality of life form
6 9 12 18 and 24 Month Follow-Ups Information is recorded as three months follow-up
Ethical Considerations
It is unknown whether physical exercise will influence the rate of recurrent vascular events MI and mortality after an ischaemic stroke It is however assumed that physical activity may favourably influence the prognosis Therefore all patients in the trial will be advised as to a healthy lifestyle including the possible benefit of physical exercise Those who are randomised to the active group will in addition receive special instruction by the physiotherapist and a physician The trial shall be accepted by the local ethics committees and informed written consent is a requirement for participation in the study Participation is voluntary and the patients can choose to withdraw from the study at any time
Outcome Event Adjudication Committee
The outcome event adjudication committee will blindly evaluate and adjudicate events such as death causes of death recurrent stroke MI and traumatic event or other adverse events
The Independent Data Safety and Monitoring Board DSMB
DSMB will receive blinded data from the Trial Data Center The DSMB will evaluate events such as death causes of death recurrent stroke MI and adverse effects The DSMB may advise early interruption of the trial if analyses demonstrate significant difference in the occurrence of secondary outcome measures with p 0001 between group A and group B
The DSMB will also follow the development of serious adverse events occurring in the 2 intervention arms of the trial
Finance and Insurance
Financial support for the study will be applied for in national private and public funds Insurance will follow national regulations
Publication Policy
The main publication will be submitted to a major peer reviewed international journal All investigators who are not included as co-authors will be acknowledged in an appendix
The ExStroke Pilot Trial
A randomised clinical trial
Investigation group
Principal investigator
Gudrun Boysen Professor DMSc Department of Neurology Bispebjerg University Hospital
Co-investigators
2400 Copenhagen NV
Anders Pedersen Project Nurse
Lars-Henrik Krarup MD
Thomas Truelsen MD PhD
Lotte Hansen Physiotherapist
Marianne Lindahl Physiotherapist
Christian Gluud DMSc Copenhagen Trial Unit Rigshospitalet 2100 Copenhagen Ø
Introduction
Physical activity is associated with a lower risk of first-time stroke It is unknown if physical exercise reduces risk of recurrent stroke Clinicians treating stroke patients are inevitably confronted with the question of how to reduce the risk of a second stroke In addition to the risk of recurrent stroke a stroke survivor is also at risk of suffering acute myocardial infarction MI and other cardiovascular complications Efforts to reduce cardiovascular risk may potentially also reduce stroke risk
Physical activity as contrasted to sedentary lifestyle is associated with a reduced risk of first stroke but in one of these studies the reduction in stroke risk did not reach statistical significance In a Norwegian study the relative risk of stroke mortality was 056 95 confidence interval CI 036 - 088 in physically active women aged 70-79 years compared to women with lower physical activity
Purpose of the ExStroke Trial
To evaluate the effect of instruction in physical training on Physical Activity Scale for Elderly PASEin patients with ischemic stroke
Other endpoints are recurrent stroke MI death of all causes and vascular death after an ischaemic stroke in patients randomised to receive verbal instruction by a stroke physiciana neurologist and a physiotherapist concurrently with written information on physical exercise versus a control group which is to receive standard information on the usefulness of physical activity Both groups will receive physiotherapy according to the usual standards of the department to which the patients are admitted
The Interventions
Physical exercise after discharge from hospital
Patients randomised to the physical exercise group shall have a session with a stroke physiciana neurologist and a physiotherapist in which the patients possibilities and wishes of training activity after discharge are discussed In agreement with the patient a training program is designed for the individual patient according to the patients resources and capability The training program on which the patient the physician and the physiotherapist have agreed must be written down the patient will keep a copy of the training program another copy is kept in the patient files and a third copy is kept in Clinical Record Form CRF
At the follow-up visits the level of physical activity is evaluated using the Physical Activity Scale in the Elderly PASE in both groups and the Copenhagen City Heart Study questionnaire on physical activity
It is recommended that patients in the active group should be contacted between the follow-up sessions by the physiotherapist in order to stimulate physical exercise Patients in the control group shall receive the same high quality medical care but without further discussion of physical training unless the patient requests such information
Hypotheses
Several studies have shown that a certain amount of physical activity is associated with reduced risk of first-ever stroke It is hypothesised that a certain level of physical exercise in patients with ischaemic stroke will reduce the risk of subsequent cardio-vascular events The following hypotheses will be tested
Level of physical activity will increase when patients are instructed in a physical training program
The incidence of recurrent stroke MI or death following an ischaemic stroke will be lower in patients who have received verbal and written instruction on physical exercise compared with those in the control group
Outcome Measures
Primary Outcome Measure physical activity as measured by PASE
Secondary Outcome Measure time from randomisation to recurrent stroke or to MI or to death of all causes
Third Outcome Measure time from randomisation to recurrent stroke MI and vascular death
Fourth Outcome Measure frequency of recurrent stroke
Fifth Outcome Measure activities of daily living as measured by modified Rankin Scale
Sixth Outcome Measure quality of life
Seventh Outcome Measure frequency of falls and fractures
Study Design
Consecutive patients meeting all inclusion criteria and none of the exclusion criteria will be asked if they want to participate in the trial Patients will be included as soon as convenient and within 90 days after onset of an ischaemic stroke There will be follow-up sessions at 36 9 12 18 24 months The study is a randomised single blind parallel group multicenter international clinical trial
Informed Consent
Randomisation
The randomisation will be performed centrally with randomisation in blocks 11 stratifying for center sex age and stroke severity The Copenhagen Trial Unit CTU will perform the randomisation
Study Population and Planned Sample Size
Patients with ischaemic stroke being 40 years of age or older will be included in the study It is unknown if level of physical activity can be increased by repeated information given to patients with a stroke Level of physical activity is evaluated according to the PASE scale which is expected to be approximately 70 as a mean value Based on a standard deviation of 50 a minimal relevant difference of 20 in PASE score a Type I error of 5 a Type 2 error of 20 it is estimated that 100 patients should be included in each of the two study arms To take into account withdrawals and dropouts about 50 more patients should be included in each arm giving a total of 300 patients in the pilot trial
Inclusion Criteria
Subjects aged 40 years or older
Patients with a clinical diagnosis of stroke symptoms lasting 24 hours or more
CT-scan of the brain must either show a new infarct or be normal Patients only with infarcts without clinical symptoms cannot be included
Inclusion shall take place before day 90 after stroke onset
Informed consent after verbal and written information
The patient must be able to walk either unaided or with a cane or a walker
Exclusion Criteria
Patients who are unable to understand the information or who can not cooperate are excluded
Patients confined to a wheelchair or bed
CT-scanning showing intracranial haemorrhage or focal pathology other than infarction cerebral atrophy or leucoaraiosis
Modified Rankin score of 4 or 5 before the actual stroke
Serious medical disease such as AIDS metastatic cancer or abnormalities that the investigator feels may compromise the patients successful participation in the trial
Earlier randomisation in this trial
Baseline Registration
Sex and birthday
Date of qualifying stroke day month year
Type of stroke
Results of CT scan ECG and Doppler examination of carotid arteries shall be obtained
Information on treatment with anti-thrombotic medication and on treatment with anti-hypertensive medication before discharge of the index stroke
Information on blood pressure on inclusion
Weight and height
Adverse Events
Stroke patients are at risk of adverse events such as the occurrence of falls fractures
Follow-Up Visits
Follow-up examinations take place at 3 6 9 12 18 and 24 months after the inclusion of the patient in the trial On each visit the medical history shall include information on date of recurrent stroke date of transient ischaemic attacks TIA date of gastro-intestinal bleeding other bleeding episodes and date of MI falls and fractures and date of any serious adverse events
In case of hospital admissions information on diagnosis and length of stay shall be obtained
In case of death information on date of death shall be retrieved and the cause of death be given as either baseline stroke new stroke cardiac disease vascular causes or other causes
On each follow-up visit the patients randomised to physical exercise group shall have repeated instruction by the physiotherapist as to the exercises suggested at baseline or adapted to the present capability of the patient Such adapted instructions on the training program must be written down The patient shall receive a copy of it a second copy shall be inserted in the patient record and a third copy in the case record form
On each visit in all patients the physical activity scale PASE shall be completed The interview will be done by a co-investigator who is blinded as to what group the patient was randomised
Three Month Follow-Up
Information is recorded on the following items
Scandinavian Stroke Scale
Modified Rankin Scale
Blood pressure
Tobacco smoking
Alcohol consumption
Antithrombotic medication
Antihypertensive medication
PASE form
Events such as recurrent stroke MI or adverse events are recorded
Quality of life form
6 9 12 18 and 24 Month Follow-Ups Information is recorded as three months follow-up
Ethical Considerations
It is unknown whether physical exercise will influence the rate of recurrent vascular events MI and mortality after an ischaemic stroke It is however assumed that physical activity may favourably influence the prognosis Therefore all patients in the trial will be advised as to a healthy lifestyle including the possible benefit of physical exercise Those who are randomised to the active group will in addition receive special instruction by the physiotherapist and a physician The trial shall be accepted by the local ethics committees and informed written consent is a requirement for participation in the study Participation is voluntary and the patients can choose to withdraw from the study at any time
Outcome Event Adjudication Committee
The outcome event adjudication committee will blindly evaluate and adjudicate events such as death causes of death recurrent stroke MI and traumatic event or other adverse events
The Independent Data Safety and Monitoring Board DSMB
DSMB will receive blinded data from the Trial Data Center The DSMB will evaluate events such as death causes of death recurrent stroke MI and adverse effects The DSMB may advise early interruption of the trial if analyses demonstrate significant difference in the occurrence of secondary outcome measures with p 0001 between group A and group B
The DSMB will also follow the development of serious adverse events occurring in the 2 intervention arms of the trial
Finance and Insurance
Financial support for the study will be applied for in national private and public funds Insurance will follow national regulations
Publication Policy
The main publication will be submitted to a major peer reviewed international journal All investigators who are not included as co-authors will be acknowledged in an appendix
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None