Clinical trial NCT04945174: 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
Overall status: RECRUITING
Phase: NA
Conditions: Minor Stroke
Non-disabling Stroke
Transient Ischemic Attack
Keywords: Minor stroke
Stroke prevention
Physical exercise
Patient education
Cardiorespiratory fitness
Non-disabling stroke
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months
timeFrame: from baseline to 3 months (post-intervention)
Secondary outcomes:
measure: Change in Physical Activity Scale
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in Physical Activity Scale from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in The WHO-5 Well-being index from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in Montreal Cognitive Assessment from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in Anxiety and depression from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in Anxiety and depression from baseline 12-months post-stroke
timeFrame: From baseline 12-months post-stroke
measure: Change in Fatigue Severity Scale from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in Fatigue Severity Scale from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in The Multidimensional Fatigue Inventory from baseline to 3-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in The Multidimensional Fatigue Inventory from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in blood pressure from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in blood pressure from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in body mass index from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in body mass index from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in Modified rankin scale from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in Modified rankin scale from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in high-sensitivity C-reactive protein from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in high-sensitivity C-reactive protein from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in Pro brain natriuretic peptid from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in Pro brain natriuretic peptid from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in Cathepsin B from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in Cathepsin B from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
measure: Change in the Stages of exercise behavior change from baseline to 3 months post-stroke
timeFrame: from baseline to 3 months (post-intervention)
measure: Change in the Stages of exercise behavior change from baseline to 12-months post-stroke
timeFrame: From baseline to 12-months post-stroke
Other outcomes:
measure: Number of patients with cardiovascular event from baseline to 5 years post-stroke
timeFrame: 5 years post-stroke
measure: Number of patients who have died from baseline to 5 years post-stroke
timeFrame: 5 years post stroke
Locations:
city: Copenhagen
country: Denmark
facility: Herlev Hospital
state: Herlev
city: Herlev
country: Denmark
facility: Department of Neurology, Herlev-Gentofte Hospital
Study officials:
affiliation: Herlev Gentofte Hospital, Department of Neurology
name: Christina Kruuse, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev Gentofte hospital, Department of Neurology,
name: Anders Hougaard, MD, Ph.d.
role: STUDY_DIRECTOR
References: