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Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions

Primary Purpose

Minor Stroke, Non-disabling Stroke, Transient Ischemic Attack

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cardiorespiratory exercise combined with patient education and individual follow-up sessions
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Minor Stroke focused on measuring Minor stroke, Stroke prevention, Physical exercise, Patient education, Cardiorespiratory fitness, Non-disabling stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Herlev HospitalRecruiting
  • Department of Neurology, Herlev-Gentofte HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Exercise

Usual care

Arm Description

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

The usual care group is encouraged to perform home-based aerobic exercise on their own

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke
A maximal exercise test on a stationary bicycle
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
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
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
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
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
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
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
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
Change in blood pressure from baseline to 3 months post-stroke
Assessment of blood pressure (systolic and diastolic)
Change in blood pressure from baseline to 12-months post-stroke
Assessment of blood pressure (systolic and diastolic)
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).
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).
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".
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".
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).
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).
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)
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)
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)
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)
Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke
detection of number of new infarcts or white matter lesions
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.
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.
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
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

Full Information

First Posted
April 27, 2021
Last Updated
June 14, 2022
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04945174
Brief Title
Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions
Official Title
Stroke School - Cross-sectorial Physical Exercise for Patients With Minor Stroke or Non-disabling Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minor Stroke, Non-disabling Stroke, Transient Ischemic Attack
Keywords
Minor stroke, Stroke prevention, Physical exercise, Patient education, Cardiorespiratory fitness, Non-disabling stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
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
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The usual care group is encouraged to perform home-based aerobic exercise on their own
Intervention Type
Behavioral
Intervention Name(s)
Cardiorespiratory exercise combined with patient education and individual follow-up sessions
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months
Description
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
Time Frame
from baseline to 3 months (post-intervention)
Secondary Outcome Measure Information:
Title
Change in Physical Activity Scale
Description
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.
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in Physical Activity Scale from baseline to 12-months post-stroke
Description
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.
Time Frame
From baseline to 12-months post-stroke
Title
Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke
Description
A maximal exercise test on a stationary bicycle
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke
Description
A questionnaire measuring current mental well-being on a scale from 0-100 points where higher points indicates better mental well-being
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in The WHO-5 Well-being index from baseline to 12-months post-stroke
Description
A questionnaire measuring current mental well-being on a scale from 0-100 points where higher points indicates better mental well-being
Time Frame
From baseline to 12-months post-stroke
Title
Change in Montreal Cognitive Assessment from baseline to 3 months post-stroke
Description
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
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke
Description
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
Time Frame
From baseline to 12-months post-stroke
Title
Change in Beck Depression Inventory from baseline to 3 months post-stroke
Description
A self-report mood questionnaire. The total score ranges from 0-63 points, and a high total score indicates more severe depressive symptoms
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in Beck Depression Inventory from baseline 12-months post-stroke
Description
A self-report mood questionnaire. The total score ranges from 0-63 points, and a high total score indicates more severe depressive symptoms
Time Frame
From baseline 12-months post-stroke
Title
Change in Fatigue Severity Scale from baseline to 3 months post-stroke
Description
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
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in Fatigue Severity Scale from baseline to 12-months post-stroke
Description
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
Time Frame
From baseline to 12-months post-stroke
Title
Change in blood pressure from baseline to 3 months post-stroke
Description
Assessment of blood pressure (systolic and diastolic)
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in blood pressure from baseline to 12-months post-stroke
Description
Assessment of blood pressure (systolic and diastolic)
Time Frame
From baseline to 12-months post-stroke
Title
Change in body mass index from baseline to 3 months post-stroke
Description
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).
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in body mass index from baseline to 12-months post-stroke
Description
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).
Time Frame
From baseline to 12-months post-stroke
Title
Change in Modified rankin scale from baseline to 3 months post-stroke
Description
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".
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in Modified rankin scale from baseline to 12-months post-stroke
Description
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".
Time Frame
From baseline to 12-months post-stroke
Title
Change in high-sensitivity C-reactive protein from baseline to 3 months post-stroke
Description
Blood samples to evaluate degree of inflammation (low risk: < 1 mg/L, average risk: 1-3 mg/L, and high risk: >3 mg/L).
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in high-sensitivity C-reactive protein from baseline to 12-months post-stroke
Description
Blood samples to evaluate degree of inflammation (low risk: < 1 mg/L, average risk: 1-3 mg/L, and high risk: >3 mg/L).
Time Frame
From baseline to 12-months post-stroke
Title
Change in Pro brain natriuretic peptid from baseline to 3 months post-stroke
Description
Blood samples to evaluate cardiac function (normal: < 125 pg/mL, critical value: > 400 pg/mL)
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in Pro brain natriuretic peptid from baseline to 12-months post-stroke
Description
Blood samples to evaluate cardiac function (normal: < 125 pg/mL, critical value: > 400 pg/mL)
Time Frame
From baseline to 12-months post-stroke
Title
Change in Cathepsin B from baseline to 3 months post-stroke
Description
Blood samples to evaluate muscle protein. (high level of Cathepsin B may associate to improve cognitive function)
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in Cathepsin B from baseline to 12-months post-stroke
Description
Blood samples to evaluate muscle protein. (high level of Cathepsin B may associate to improve cognitive function)
Time Frame
From baseline to 12-months post-stroke
Title
Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke
Description
detection of number of new infarcts or white matter lesions
Time Frame
From baseline to 12-months post-stroke
Title
Change in outcome expectancy for exercise-2 scale from baseline to 3 months post-stroke
Description
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.
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in outcome expectancy for exercise-2 scale from baseline to 12-months post-stroke
Description
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.
Time Frame
From baseline to 12-months post-stroke
Title
Change in the Stages of exercise behavior change from baseline to 3 months post-stroke
Description
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
Time Frame
from baseline to 3 months (post-intervention)
Title
Change in the Stages of exercise behavior change from baseline to 12-months post-stroke
Description
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
Time Frame
From baseline to 12-months post-stroke
Other Pre-specified Outcome Measures:
Title
Number of patients with cardiovascular event from baseline to 5 years post-stroke
Description
Follow-up 5 years from inclusion on cardiovascular events
Time Frame
5 years post-stroke
Title
Number of patients who have died from baseline to 5 years post-stroke
Description
Follow-up 5 years from inclusion on death
Time Frame
5 years post stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Kruuse, Professor
Phone
+45 3868 1233
Email
christina.kruuse@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Rikke Steen Krawcyk, Ph.d
Phone
+45 3868 6159
Email
rikke.steen.krawcyk@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Kruuse, Professor
Organizational Affiliation
Herlev Gentofte Hospital, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Copenhagen
State/Province
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Kruuse, Professor
Phone
+45 3868 1233
Email
christina.kruuse@regionh.dk
First Name & Middle Initial & Last Name & Degree
Rikke Steen Krawcyk, ph.d.
Phone
+45 3868 6159
Email
rikke.steen.krawcyk@regionh.dk
Facility Name
Department of Neurology, Herlev-Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Kruuse, MD, DMSc
Phone
+4538681233

12. IPD Sharing Statement

Plan to Share IPD
No

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Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions

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