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

Herlev Hospital

Status: Enrolling

Conditions: Minor Stroke; Transient Ischemic Attack; Non-disabling Stroke

Treatments: Behavioral: Cardiorespiratory exercise combined with patient education and individual follow-up sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT04945174

H-20059985

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Exercise

Active Comparator group

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

Treatment:

Behavioral: Cardiorespiratory exercise combined with patient education and individual follow-up sessions

Usual care

No Intervention group

Description:

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