Cerebrovascular DisordersNCT01924247
Study to Validate the Effects of an Outpatient Secondary Prevention Program for Stroke Victims
A study testing Outpatient secondary prevention program and Standard treatment by family physician in people with Cerebrovascular Disorders and Stroke, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Background: Stroke represents one of the major health problems worldwide, particularly in transitional and industrialized countries. Stroke has a remarkable socioeconomic impact, especially in the ageing population, and therefore stroke prevention is important. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebrovascular Disorders, Stroke, Prevention
- What is being tested?
- Outpatient secondary prevention program and Standard treatment by family physician
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ischemic stroke and TIA
- Age between 18 and 75 years
- Minor or no residual neurological deficits (mRS 0-1)
- Written consent by the patient
Who cannot join
- Severe congestive heart failure (NYHA IV)
- Evidence of disabling stroke or dementia as measured by modified Rankin Scale score of ≥3 or a MOCA score < 26
- Any medical condition which disables a patient to participate physical exercise training
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurology, Bern University Hospital
Bern, 3010
About this study
Official title: Prospective Randomized Study to Validate the Effects of an Outpatient Secondary Prevention Program for Stroke Victims With Minor or no Residual Deficits
Background:
Stroke represents one of the major health problems worldwide, particularly in transitional and industrialized countries. Stroke has a remarkable socioeconomic impact, especially in the ageing population, and therefore stroke prevention is important. Secondary preventive measures and rehabilitation are essential for reduction of recurrent events. However, to date appropriate secondary preventive programs for patients surviving a stroke with minor or no residual deficits have been poorly studied.
Read more
Specific aims/projects:
The aim of this study is to validate the effects of an outpatient secondary prevention program on vascular risk factors, adherence to vascular-protective medication, exercise capacity and health related quality of life.
Working Hypothesis:
The outpatient rehabilitation program results in a significant short (3 months) and long-term (1 year) improvement of vascular risk factors, neurological functions, exercise capacity, adherence to vasoprotective medication and health related quality of life.
Experimental design/Methods:
This is a prospective, randomized clinical trial. At least 100 patients will be randomized either to the interventional group or to a group which is treated only by the family physician. All patients will be assessed at baseline, at 3 months and 1 year. The primary outcome is the number of reached cardiovascular health goals (6 metrics) between the interventional group and the group which is treated only by the family physician.
Expected value of the proposed project:
The study has the potential to show that an outpatient rehabilitation program significantly improves vascular risk factors, adherence to medication, enhances quality of life and eventually reduces recurrent strokes and other vascular events. If this is confirmed, introducing outpatient rehabilitation programs will have a major socioeconomic impact.
Read the detailed description
Background
Stroke represents one of the major health problems worldwide, particularly in transitional and industrialized countries. Stroke ranks first as cause of handicap in adults, second as cause of dementia, third as cause of death and is a frequent cause of epilepsy, depression, falls and acute hospital admissions. Stroke has a remarkable socioeconomic impact, especially in the ageing population, and therefore stroke prevention is important.
Stroke begets stroke. Persons who have suffered a stroke are at high risk of suffering additional strokes. Therefore, prevention in these persons should be part of their medical management. However, secondary stroke prevention is complex due to the numerous risk factors and includes pharmacological interventions and non-pharmacological means for risk factor reduction. Up to 90% of the stroke risk is attributable to vascular risk factors. Therefore, appropriate use of all proven measures of risk factor reduction could prevent up to 90% of all strokes. This includes smoking cessation, control of hypertension and diabetes, anticoagulants or antiplatelet agents and lipid lowering drugs, a healthy lifestyle with regular physical activity, healthy normocaloric diet, moderate or no alcohol consumption, low-normal body weight and avoidance of distress. Importantly, effective stroke prevention can only be achieved by the reduction of several or all vascular risk factors.
Secondary preventive measures and rehabilitation are essential for reduction of recurrent events. Furthermore, moderate to severely handicapped patients should receive in- and outpatient rehabilitation adapted to their individual deficits. The concept of secondary prevention through cardiac rehabilitation is an accepted treatment modality in patients after myocardial infarction or aortocoronary bypass surgery. However, appropriate secondary preventive programs for patients surviving a stroke with minor or no residual deficits are lacking. Therefore, the investigators developed a structured 12 week hospital based out-patient program for stroke patients with minor or no residual deficits based on the already existing format of cardiac rehabilitation to optimize secondary stroke prevention, relieve symptoms, improve neurological functioning, and improve health related quality of life.
In a prospective interventional single center cohort pilot study with 105 patients (that is submitted for publication), the investigators showed that a 12 week outpatient rehabilitation program resulted in a considerable improvement of vascular risk factors, neurological functions, and enhanced health related quality of life (see attached abstract).
The aim of this additional study is to validate the effects of this outpatient program in a prospective, randomized clinical trial with crossover design.
Objective
The aim of this study is to validate the effects of an outpatient secondary prevention program on vascular risk factors, adherence to vascular-protective medication, exercise capacity and health related quality of life.
Methods
This is a prospective, randomized clinical trial. At least 100 patients with minor stroke or transient ischemic attack treated in the University Hospital of Bern will be randomized either to the interventional group or to a group which is treated only by the family physician. All patients will be assessed at baseline, at 3 months and 1 year. The primary outcome is the number of reached cardiovascular health goals (6 metrics: smoking, physical exercise capacity, Mediterranean diet compliance, LDL-Cholesterol, Blood pressure, fasting plasma glucose) between the interventional group and the group which is treated only by the family physician. After inclusion of 100 patients in the study, a study independent statistician will perform a power analysis and the final number of patients to be included will be adapted.
- Conditions
- Cerebrovascular Disorders, Stroke, Prevention
- Being tested
- Outpatient secondary prevention program, Standard treatment by family physician
- Medical subject headings
- Cerebrovascular Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient secondary prevention programBehavioural
The comprehensive outpatient program is designed to last for 12 weeks. Participants are treated in groups of 8 or less. Every week there are two days with therapeutic and educational sessions, once with two hours of physical exercise therapy and once with 45 minutes of aerobic ergometer training and one hour of lecture and counseling. On the day with the two hours of physical therapy one of the sessions includes aerobic ergometer training or Nordic walking, and the other session focuses on improvements of fine motor skills, coordination, balance, mobilization, stretching, weight training or breathing. The lectures include three lectures on etiology, diagnosis, treatment and prevention of stroke by a neurologist, one on vascular risk factors by a cardiologist, five on nutrition counseling by nutritionists, two on active and passive smoking cessation and one lecture on psychological coping strategies given by a neuropsychologist.
Standard treatment by family physicianBehavioural
Standard treatment by family physician.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Other | Interventional Arm Receives: Behavioral: Outpatient secondary prevention program |
| Control Arm | Other | Control Arm: Standard treatment by family physician Receives: Behavioral: Standard treatment by family physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of a combined endpoint of physical exercise capacity, blood pressure, LDL-cholesterol, HDL-cholesterol, mediterranean diet compliance, and smoking status
The primary endpoint is a combined endpoint of improvement of physical exercise capacity, blood pressure, LDL-cholesterol, HDL-cholesterol, mediterranean diet compliance, and smoking status between the interventional arm and the control arm.
Measured: 3 months
Secondary outcomes (7)
Comparison of neurological function
NIHSS, mRS, 9-Hole-Peg-Test, Functional gait assessment
Measured: 3 months
Comparison of inflammation marker
C-reactive protein (CRP)
Measured: at 3 months
Comparison of adherence to prescribed medication
Measured: 3 months
Rate of new diagnosed overseen neurological deficits
Measured: 3 months
Comparison of quality-of-life questionnaires
SF 36, DS 14, HADS, Jenkins 4-Items Quest, Fatigue Skala für Motorik und Kognition, EUROQUAL, Stroke Specific Quality of Life, PH Q-9, WHOQQL Bref, Mediterranean Diet Compliance Questionnaire, SWISSPAQ
Measured: 3 months
Comparison of the primary outcome measures between the interventional arm and the control arm
Measured: at 3 months, at 12 months
Comparison of drop-out rate between the interventional arm and the control arm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startNov 2013
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Schweizerische Herzstiftung
- Responsible party
- Sponsor
- Investigators
- Simon Jung, MD, Principal investigator, Department of Neurology, University Hospital of Bern, 3010 Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924247
- Sponsor's protocol ID
- 090/13
- Status last verified
- Mar 2023
- First submitted
- 9 Aug 2013
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Validate the Effects of an Outpatient Secondary Prevention Program for Stroke Victims With Minor or no Residual Deficits
- ClinicalTrials.gov ID
- NCT01924247
- Acronym / sponsor ID
- 090/13
- Conditions
- Cerebrovascular Disorders, Stroke, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Schweizerische Herzstiftung
- Study start
- Nov 2013 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Stroke represents one of the major health problems worldwide, particularly in transitional and industrialized countries. Stroke has a remarkable socioeconomic impact, especially in the ageing population, and therefore stroke prevention is important. Secondary preventive measures and rehabilitation are essential for reduction of recurrent events. However, to date appropriate secondary preventive programs for patients surviving a stroke with minor or no residual deficits have been poorly studied.
Specific aims/projects:
The aim of this study is to validate the effects of an outpatient secondary prevention program on vascular risk factors, adherence to vascular-protective medication, exercise capacity and health related quality of life.
Working Hypothesis:
The outpatient rehabilitation program results in a significant short (3 months) and long-term (1 year) improvement of vascular risk factors, neurological functions, exercise capacity, adherence to vasoprotective medication and health related quality of life.
Experimental design/Methods:
This is a prospective, randomized clinical trial. At least 100 patients will be randomized either to the interventional group or to a group which is treated only by the family physician. All patients will be assessed at baseline, at 3 months and 1 year. The primary outcome is the number of reached cardiovascular health goals (6 metrics) between the interventional group and the group which is treated only by the family physician.
Expected value of the proposed project:
The study has the potential to show that an outpatient rehabilitation program significantly improves vascular risk factors, adherence to medication, enhances quality of life and eventually reduces recurrent strokes and other vascular events. If this is confirmed, introducing outpatient rehabilitation programs will have a major socioeconomic impact.
Detailed description
Background
Stroke represents one of the major health problems worldwide, particularly in transitional and industrialized countries. Stroke ranks first as cause of handicap in adults, second as cause of dementia, third as cause of death and is a frequent cause of epilepsy, depression, falls and acute hospital admissions. Stroke has a remarkable socioeconomic impact, especially in the ageing population, and therefore stroke prevention is important.
Stroke begets stroke. Persons who have suffered a stroke are at high risk of suffering additional strokes. Therefore, prevention in these persons should be part of their medical management. However, secondary stroke prevention is complex due to the numerous risk factors and includes pharmacological interventions and non-pharmacological means for risk factor reduction. Up to 90% of the stroke risk is attributable to vascular risk factors. Therefore, appropriate use of all proven measures of risk factor reduction could prevent up to 90% of all strokes. This includes smoking cessation, control of hypertension and diabetes, anticoagulants or antiplatelet agents and lipid lowering drugs, a healthy lifestyle with regular physical activity, healthy normocaloric diet, moderate or no alcohol consumption, low-normal body weight and avoidance of distress. Importantly, effective stroke prevention can only be achieved by the reduction of several or all vascular risk factors.
Secondary preventive measures and rehabilitation are essential for reduction of recurrent events. Furthermore, moderate to severely handicapped patients should receive in- and outpatient rehabilitation adapted to their individual deficits. The concept of secondary prevention through cardiac rehabilitation is an accepted treatment modality in patients after myocardial infarction or aortocoronary bypass surgery. However, appropriate secondary preventive programs for patients surviving a stroke with minor or no residual deficits are lacking. Therefore, the investigators developed a structured 12 week hospital based out-patient program for stroke patients with minor or no residual deficits based on the already existing format of cardiac rehabilitation to optimize secondary stroke prevention, relieve symptoms, improve neurological functioning, and improve health related quality of life.
In a prospective interventional single center cohort pilot study with 105 patients (that is submitted for publication), the investigators showed that a 12 week outpatient rehabilitation program resulted in a considerable improvement of vascular risk factors, neurological functions, and enhanced health related quality of life (see attached abstract).
The aim of this additional study is to validate the effects of this outpatient program in a prospective, randomized clinical trial with crossover design.
Objective
The aim of this study is to validate the effects of an outpatient secondary prevention program on vascular risk factors, adherence to vascular-protective medication, exercise capacity and health related quality of life.
Methods
This is a prospective, randomized clinical trial. At least 100 patients with minor stroke or transient ischemic attack treated in the University Hospital of Bern will be randomized either to the interventional group or to a group which is treated only by the family physician. All patients will be assessed at baseline, at 3 months and 1 year. The primary outcome is the number of reached cardiovascular health goals (6 metrics: smoking, physical exercise capacity, Mediterranean diet compliance, LDL-Cholesterol, Blood pressure, fasting plasma glucose) between the interventional group and the group which is treated only by the family physician. After inclusion of 100 patients in the study, a study independent statistician will perform a power analysis and the final number of patients to be included will be adapted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Other | Behavioral: Outpatient secondary prevention programInterventional Arm |
| Control Arm | Other | Behavioral: Standard treatment by family physicianControl Arm: Standard treatment by family physician |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ischemic stroke and TIA
- Age between 18 and 75 years
- Minor or no residual neurological deficits (mRS 0-1)
- Written consent by the patient
Key exclusion criteria (3 listed)
- Severe congestive heart failure (NYHA IV)
- Evidence of disabling stroke or dementia as measured by modified Rankin Scale score of ≥3 or a MOCA score < 26
- Any medical condition which disables a patient to participate physical exercise training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient secondary prevention programThe comprehensive outpatient program is designed to last for 12 weeks. Participants are treated in groups of 8 or less. Every week there are two days with therapeutic and educational sessions, once with two hours of physical exercise therapy and once with 45 minutes of aerobic ergometer training and one hour of lecture and counseling. On the day with the two hours of physical therapy one of the sessions includes aerobic ergometer training or Nordic walking, and the other session focuses on improvements of fine motor skills, coordination, balance, mobilization, stretching, weight training or breathing. The lectures include three lectures on etiology, diagnosis, treatment and prevention of stroke by a neurologist, one on vascular risk factors by a cardiologist, five on nutrition counseling by nutritionists, two on active and passive smoking cessation and one lecture on psychological coping strategies given by a neuropsychologist. | Behavioural | Interventional Arm |
| Standard treatment by family physicianStandard treatment by family physician. | Behavioural | Control Arm |
Primary outcome
Improvement of a combined endpoint of physical exercise capacity, blood pressure, LDL-cholesterol, HDL-cholesterol, mediterranean diet compliance, and smoking status
Time frame: 3 months
The primary endpoint is a combined endpoint of improvement of physical exercise capacity, blood pressure, LDL-cholesterol, HDL-cholesterol, mediterranean diet compliance, and smoking status between the interventional arm and the control arm.
7 secondary outcomes
Comparison of neurological function
Time frame: 3 months
Comparison of inflammation marker
Time frame: at 3 months
Comparison of adherence to prescribed medication
Time frame: 3 months
Rate of new diagnosed overseen neurological deficits
Time frame: 3 months
Comparison of quality-of-life questionnaires
Time frame: 3 months
Comparison of the primary outcome measures between the interventional arm and the control arm
Time frame: at 3 months, at 12 months
Comparison of drop-out rate between the interventional arm and the control arm
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Jung, MD principal investigator
Department of Neurology, University Hospital of Bern, 3010 Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient secondary prevention program and Standard treatment by family physician in people with Cerebrovascular Disorders and Stroke, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of a combined endpoint of physical exercise capacity, blood pressure, LDL-cholesterol, HDL-cholesterol, mediterranean diet compliance, and smoking status (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.