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

NCT ID: NCT04945174

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2033-12-31

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.

Conditions

Minor Stroke; Non-disabling Stroke; Transient Ischemic Attack

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Exercise

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christina Kruuse

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Kruuse, Professor

Role: PRINCIPAL_INVESTIGATOR

Herlev Gentofte Hospital, Department of Neurology

Anders Hougaard, MD, Ph.d.

Role: STUDY_DIRECTOR

Herlev Gentofte hospital, Department of Neurology,

Locations

Herlev Hospital

Copenhagen, Herlev, Denmark

Site Status: RECRUITING

Department of Neurology, Herlev-Gentofte Hospital

Herlev, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Christina Kruuse, Professor

Role: CONTACT

christina.kruuse@regionh.dk

+45 3868 1233

Rikke Steen Krawcyk, Ph.d

Role: CONTACT

rikke.steen.krawcyk@regionh.dk

+45 3868 6159

Facility Contacts

Christina Kruuse, Professor

Role: primary

christina.kruuse@regionh.dk

+45 3868 1233

Rikke Steen Krawcyk, ph.d.

Role: backup

rikke.steen.krawcyk@regionh.dk

+45 3868 6159

Christina Kruuse, MD, DMSc

Role: primary

+4538681233

Other Identifiers

H-20059985

Identifier Type: -

Identifier Source: org_study_id