- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04945174
Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions
Stroke School - Cross-sectorial Physical Exercise for Patients With Minor Stroke or Non-disabling Stroke
Study Overview
Status
Detailed Description
Hypertension and physical inactivity are the most common risk factors for stroke. Patients with minor stroke or transient ischemic attack (TIA) have short-lasting symptoms, often with remission within hours or days. Though patients experience a quick remission, they have an increased risk of a recurrent stroke and progressive cognitive dysfunction. The patients are also likely to have other disposing risk factors such as diabetes, smoking, and hypercholesterolemia which may increase the risk of a recurrent stroke. Following hospital discharge, the patients are offered preventive medication, but no standardized rehabilitation or exercise. Previous studies have shown that physical exercise decreases cardiovascular risk factors for patients after stroke and increases physical function and quality of life.
The aim is to develop and evaluate a standardized exercise program (a stroke school) for patients with minor stroke or TIA. The intervention consist of 6 weeks of supervised aerobic exercise at the hospital combined with patient education including knowledge on stroke risk factors. Subsequently, 6 weeks of supervised aerobic exercise in their local municipality. After the 12 weeks of exercise, patients are offered individual, motivational follow-up sessions with the purpose to facilitate the patients to stay physically active in their everyday life.
This intervention will increase the patients´ knowledge regarding risk factors for stroke and cardiovascular disease, increase their cardiorespiratory fitness and facilitate the patients to be physical active and hopefully slow the progression of vascular disease.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christina Kruuse, Professor
- Phone Number: +45 3868 1233
- Email: christina.kruuse@regionh.dk
Study Contact Backup
- Name: Rikke Steen Krawcyk, Ph.d
- Phone Number: +45 3868 6159
- Email: rikke.steen.krawcyk@regionh.dk
Study Locations
-
-
-
Herlev, Denmark, 2730
- Recruiting
- Department of Neurology, Herlev-Gentofte Hospital
-
Contact:
- Christina Kruuse, MD, DMSc
- Phone Number: +4538681233
-
-
Herlev
-
Copenhagen, Herlev, Denmark, 2730
- Recruiting
- Herlev Hospital
-
Contact:
- Christina Kruuse, Professor
- Phone Number: +45 3868 1233
- Email: christina.kruuse@regionh.dk
-
Contact:
- Rikke Steen Krawcyk, ph.d.
- Phone Number: +45 3868 6159
- Email: rikke.steen.krawcyk@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with a minor stroke or TIA without the need of rehabilitation after hospital discharge, but need physical activity in order to prevent cardiovascular diseases
- Patients spending ≤ 5 hour of leisure time on high-intensity physical activity on weekly basis within the last 3 months
- Able to speak and read Danish and to provide informed consent
- Individuals ≥ 18 years of age
Exclusion Criteria:
- Previous large-artery stroke or hemorrhagic stroke
- Unstable cardiac condition, e.g. pacemaker
- Uncontrolled hypertension (patients not responding adequately to antihypertensive medication when applying treatment according to guidelines)
- Symptoms or comorbidities not allowing exercise on a stationary bicycle (e.g. claudication)
- Dyspnoea caused by heart or pulmonary disease (e.g. COPD)
- Aphasia, or dementia that interferer with understanding the protocol and/or physical examinations.
- Patients diagnosed with dementia at hospital admission (a score ≤23/30 on the Mini-Mental State Examination are not invited into the study)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise
12 weeks of supervised cardiorespiratory exercise twice a week (6 weeks at the hospital and 6 weeks in the local municipality) combined with patient education and individual follow-up sessions
|
6 weeks of cardiorespiratory exercise combined with patient education at the hospital, followed by 6 weeks of cardiorespiratory exercise in the local municipality.
Subsequently individual follow-up sessions with the aim to facilitate the patients to stay physically active in their everyday life
|
No Intervention: Usual care
The usual care group is encouraged to perform home-based aerobic exercise on their own
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months
Time Frame: from baseline to 3 months (post-intervention)
|
A sub-maximal exercise test on a stationary bicycle where the workload increases by 15 Watts (W) every minute and each minute the patient recites a standardized text passage.
When the patient is no longer able to speak comfortably the test terminates.
The higher score the better cardiorespiratory fitness
|
from baseline to 3 months (post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Physical Activity Scale
Time Frame: from baseline to 3 months (post-intervention)
|
A questionnaire measuring number of hours of self-reported physical activity during daily living.
It reveals daily time spent on sleep, sitting down at work, standing/walking at work, heavy physical work during working hours, active commuting to/from work, and sedentary behavior, including television watching and reading.
Additionally, the patients record the weekly time spent on light-intensity, moderate-intensity, and vigorous-intensity activity during leisure time.
|
from baseline to 3 months (post-intervention)
|
Change in Physical Activity Scale from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
A questionnaire measuring number of hours of self-reported physical activity during daily living.
It reveals daily time spent on sleep, sitting down at work, standing/walking at work, heavy physical work during working hours, active commuting to/from work, and sedentary behavior, including television watching and reading.
Additionally, the patients record the weekly time spent on light-intensity, moderate-intensity, and vigorous-intensity activity during leisure time.
|
From baseline to 12-months post-stroke
|
Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
A maximal exercise test on a stationary bicycle
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from baseline to 3 months (post-intervention)
|
Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
A questionnaire measuring current mental well-being on a scale from 0-100 points where higher points indicates better mental well-being
|
from baseline to 3 months (post-intervention)
|
Change in The WHO-5 Well-being index from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
A questionnaire measuring current mental well-being on a scale from 0-100 points where higher points indicates better mental well-being
|
From baseline to 12-months post-stroke
|
Change in Montreal Cognitive Assessment from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
A cognitive screening test for detection of mild cognitive impairments, the score ranges from 0-30 points and a high score indicates better cognitive function
|
from baseline to 3 months (post-intervention)
|
Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
A cognitive screening test for detection of mild cognitive impairments, the score ranges from 0-30 points and a high score indicates better cognitive function
|
From baseline to 12-months post-stroke
|
Change in Beck Depression Inventory from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
A self-report mood questionnaire.
The total score ranges from 0-63 points, and a high total score indicates more severe depressive symptoms
|
from baseline to 3 months (post-intervention)
|
Change in Beck Depression Inventory from baseline 12-months post-stroke
Time Frame: From baseline 12-months post-stroke
|
A self-report mood questionnaire.
The total score ranges from 0-63 points, and a high total score indicates more severe depressive symptoms
|
From baseline 12-months post-stroke
|
Change in Fatigue Severity Scale from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
A 20-item self-report instrument designed to measure fatigue.
The score ranges from 9-63 points, and a higher score indicates greater severity of fatigue
|
from baseline to 3 months (post-intervention)
|
Change in Fatigue Severity Scale from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
A 20-item self-report instrument designed to measure fatigue.
The score ranges from 9-63 points, and a higher score indicates greater severity of fatigue
|
From baseline to 12-months post-stroke
|
Change in blood pressure from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
Assessment of blood pressure (systolic and diastolic)
|
from baseline to 3 months (post-intervention)
|
Change in blood pressure from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
Assessment of blood pressure (systolic and diastolic)
|
From baseline to 12-months post-stroke
|
Change in body mass index from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
Measures of weight in kilograms, and height in meters will be aggregated to arrive at one reported value, the body mass index (kg/m^2).
|
from baseline to 3 months (post-intervention)
|
Change in body mass index from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
Measures of weight in kilograms, and height in meters will be aggregated to arrive at one reported value, the body mass index (kg/m^2).
|
From baseline to 12-months post-stroke
|
Change in Modified rankin scale from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
A measurement of symptoms/motor function.
The score ranges from 0-6 points, where 0 represents "no symptoms at all" and 6 points represents "dead".
|
from baseline to 3 months (post-intervention)
|
Change in Modified rankin scale from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
A measurement of symptoms/motor function.
The score ranges from 0-6 points, where 0 represents "no symptoms at all" and 6 points represents "dead".
|
From baseline to 12-months post-stroke
|
Change in high-sensitivity C-reactive protein from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
Blood samples to evaluate degree of inflammation (low risk: < 1 mg/L, average risk: 1-3 mg/L, and high risk: >3 mg/L).
|
from baseline to 3 months (post-intervention)
|
Change in high-sensitivity C-reactive protein from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
Blood samples to evaluate degree of inflammation (low risk: < 1 mg/L, average risk: 1-3 mg/L, and high risk: >3 mg/L).
|
From baseline to 12-months post-stroke
|
Change in Pro brain natriuretic peptid from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
Blood samples to evaluate cardiac function (normal: < 125 pg/mL, critical value: > 400 pg/mL)
|
from baseline to 3 months (post-intervention)
|
Change in Pro brain natriuretic peptid from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
Blood samples to evaluate cardiac function (normal: < 125 pg/mL, critical value: > 400 pg/mL)
|
From baseline to 12-months post-stroke
|
Change in Cathepsin B from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
Blood samples to evaluate muscle protein.
(high level of Cathepsin B may associate to improve cognitive function)
|
from baseline to 3 months (post-intervention)
|
Change in Cathepsin B from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
Blood samples to evaluate muscle protein.
(high level of Cathepsin B may associate to improve cognitive function)
|
From baseline to 12-months post-stroke
|
Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
detection of number of new infarcts or white matter lesions
|
From baseline to 12-months post-stroke
|
Change in outcome expectancy for exercise-2 scale from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
A questionnaire measuring self-efficacy for exercise.
The total score consist of two subscales; a postive and a negative.
The positive subscale ranges from 1-5, and a higher positive sub-score indicates stronger/more positive outcome expectations for exercise, and the negative subscale ranges from 1-4, and a higher negative sub-score indicates more negative outcome expectations for exercise.
|
from baseline to 3 months (post-intervention)
|
Change in outcome expectancy for exercise-2 scale from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
A questionnaire measuring self-efficacy for exercise.
The total score consist of two subscales; a postive and a negative.
The positive subscale ranges from 1-5, and a higher positive sub-score indicates stronger/more positive outcome expectations for exercise, and the negative subscale ranges from 1-4, and a higher negative sub-score indicates more negative outcome expectations for exercise.
|
From baseline to 12-months post-stroke
|
Change in the Stages of exercise behavior change from baseline to 3 months post-stroke
Time Frame: from baseline to 3 months (post-intervention)
|
A questionnaire consisting of six categories describing differerent stages towards exercise behavior change, ranking from no intention to change behavior (precontemplation) to sustain behavior change (maintenance). Data will be analysed by calculating the number of patients (percentage) in each category and with a comparison between groups |
from baseline to 3 months (post-intervention)
|
Change in the Stages of exercise behavior change from baseline to 12-months post-stroke
Time Frame: From baseline to 12-months post-stroke
|
A questionnaire consisting of six categories describing differerent stages towards exercise behavior change, ranking from no intention to change behavior (precontemplation) to sustain behavior change (maintenance). Data will be analysed by calculating the number of patients (percentage) in each category and with a comparison between groups |
From baseline to 12-months post-stroke
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with cardiovascular event from baseline to 5 years post-stroke
Time Frame: 5 years post-stroke
|
Follow-up 5 years from inclusion on cardiovascular events
|
5 years post-stroke
|
Number of patients who have died from baseline to 5 years post-stroke
Time Frame: 5 years post stroke
|
Follow-up 5 years from inclusion on death
|
5 years post stroke
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-20059985
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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