Transient Ischemic Attack Clinical Trial
Official title:
Stroke School - Cross-sectorial Physical Exercise for Patients With Minor Stroke or Non-disabling Stroke
NCT number | NCT04945174 |
Other study ID # | H-20059985 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | December 2029 |
In a randomized controlled trial the effect of 12 weeks of cross-sectorial physical exercise combined with patient education and individual follow-up session is investigated in patients with minor stroke or non-disabling stroke.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2029 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev Hospital | Copenhagen | Herlev |
Denmark | Department of Neurology, Herlev-Gentofte Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patients with cardiovascular event from baseline to 5 years post-stroke | Follow-up 5 years from inclusion on cardiovascular events | 5 years post-stroke | |
Other | Number of patients who have died from baseline to 5 years post-stroke | Follow-up 5 years from inclusion on death | 5 years post stroke | |
Primary | Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months | 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 | Change in Physical Activity Scale | 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) | |
Secondary | Change in Physical Activity Scale 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 | |
Secondary | Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke | A maximal exercise test on a stationary bicycle | from baseline to 3 months (post-intervention) | |
Secondary | Change in The WHO-5 Well-being index from baseline to to 3 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 3 months (post-intervention) | |
Secondary | Change in The WHO-5 Well-being index 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 | |
Secondary | Change in Montreal Cognitive Assessment from baseline to 3 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 3 months (post-intervention) | |
Secondary | Change in Montreal Cognitive Assessment 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 | |
Secondary | Change in Beck Depression Inventory from baseline to 3 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 to 3 months (post-intervention) | |
Secondary | Change in Beck Depression Inventory 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 | |
Secondary | Change in Fatigue Severity Scale from baseline to 3 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 3 months (post-intervention) | |
Secondary | Change in Fatigue Severity Scale 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 | |
Secondary | Change in blood pressure from baseline to 3 months post-stroke | Assessment of blood pressure (systolic and diastolic) | from baseline to 3 months (post-intervention) | |
Secondary | Change in blood pressure from baseline to 12-months post-stroke | Assessment of blood pressure (systolic and diastolic) | From baseline to 12-months post-stroke | |
Secondary | Change in body mass index from baseline to 3 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 3 months (post-intervention) | |
Secondary | Change in body mass index 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 | |
Secondary | Change in Modified rankin scale from baseline to 3 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 3 months (post-intervention) | |
Secondary | Change in Modified rankin scale 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 | |
Secondary | Change in high-sensitivity C-reactive protein from baseline to 3 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 3 months (post-intervention) | |
Secondary | Change in high-sensitivity C-reactive protein 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 | |
Secondary | Change in Pro brain natriuretic peptid from baseline to 3 months post-stroke | Blood samples to evaluate cardiac function (normal: < 125 pg/mL, critical value: > 400 pg/mL) | from baseline to 3 months (post-intervention) | |
Secondary | Change in Pro brain natriuretic peptid 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 | |
Secondary | Change in Cathepsin B from baseline to 3 months post-stroke | Blood samples to evaluate muscle protein. (high level of Cathepsin B may associate to improve cognitive function) | from baseline to 3 months (post-intervention) | |
Secondary | Change in Cathepsin B 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 | |
Secondary | Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke | detection of number of new infarcts or white matter lesions | From baseline to 12-months post-stroke | |
Secondary | Change in outcome expectancy for exercise-2 scale from baseline to 3 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 3 months (post-intervention) | |
Secondary | Change in outcome expectancy for exercise-2 scale 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 | |
Secondary | Change in the Stages of exercise behavior change from baseline to 3 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 3 months (post-intervention) | |
Secondary | Change in the Stages of exercise behavior change 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 |
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