Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Cardiorespiratory exercise combined with patient education and individual follow-up sessions
Behavioral6 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
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ExerciseActive comparator 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
from baseline to 3 months (post-intervention)Secondary outcomes
1
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.
Time frame
from baseline to 3 months (post-intervention)2
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.
Time frame
From baseline to 12-months post-stroke3
Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke
A maximal exercise test on a stationary bicycle
Time frame
from baseline to 3 months (post-intervention)4
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
Time frame
from baseline to 3 months (post-intervention)Other outcomes
1
Number of patients with cardiovascular event from baseline to 5 years post-stroke
Follow-up 5 years from inclusion on cardiovascular events
Time frame
5 years post-stroke2
Number of patients who have died from baseline to 5 years post-stroke
Follow-up 5 years from inclusion on death
Time frame
5 years post strokeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov