Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiorespiratory exercise combined with patient education and individual follow-up sessions.
- Who it may be relevant to
- Registry conditions: Minor Stroke, Non-disabling Stroke, Transient Ischemic Attack. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Stroke School - Cross-sectorial Physical Exercise for Patients With Minor Stroke or Non-disabling Stroke
Overview
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.
Interventions
- Behavioral Cardiorespiratory exercise 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
Primary outcome measures
- Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months [Time frame: from baseline to 3 months (post-intervention)]
Secondary outcome measures (12)
- Change in Physical Activity Scale [Time frame: 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]
- Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke [Time frame: 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)]
- Change in The WHO-5 Well-being index from baseline to 12-months post-stroke [Time frame: 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)]
- Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke [Time frame: From baseline to 12-months post-stroke]
- Change in Anxiety and depression from baseline to 3 months post-stroke [Time frame: from baseline to 3 months (post-intervention)]
- Change in Anxiety and depression from baseline 12-months post-stroke [Time frame: 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)]
- Change in Fatigue Severity Scale from baseline to 12-months post-stroke [Time frame: From baseline to 12-months post-stroke]
- Change in The Multidimensional Fatigue Inventory from baseline to 3-months post-stroke [Time frame: From baseline to 12-months post-stroke]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Denmark · 2 centers
- Herlev Hospital — Copenhagen
- Department of Neurology, Herlev-Gentofte Hospital — Herlev
Identifiers
NCT: NCT04945174 · H-20059985