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

NCT04945174 | Recruiting

• 1 other identifier: H-20059985
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Minor Stroke; Non-disabling Stroke; Transient Ischemic Attack

Keywords

Minor stroke; Stroke prevention; Physical exercise; Patient education; Cardiorespiratory fitness; Non-disabling stroke

Outcome Measures

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

  from baseline to 3 months (post-intervention)

Secondary Outcomes (28)

• Change in Physical Activity Scale

  from baseline to 3 months (post-intervention)

• Change in Physical Activity Scale from baseline to 12-months post-stroke

  From baseline to 12-months post-stroke

• Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke

  from baseline to 3 months (post-intervention)

• Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke

  from baseline to 3 months (post-intervention)

• Change in The WHO-5 Well-being index from baseline to 12-months post-stroke

  From baseline to 12-months post-stroke

Other Outcomes (2)

• Number of patients with cardiovascular event from baseline to 5 years post-stroke

  5 years post-stroke

• Number of patients who have died from baseline to 5 years post-stroke

  5 years post stroke

Study Arms (2)

Exercise

ACTIVE COMPARATOR

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

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

Usual care

NO INTERVENTION

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

Interventions

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

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (2)

Herlev Hospital

Copenhagen, Herlev, 2730, Denmark

RECRUITING

Department of Neurology, Herlev-Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Ischemic Attack, Transient; Motor Activity

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Christina Kruuse, Professor

  Herlev Gentofte Hospital, Department of Neurology

  PRINCIPAL INVESTIGATOR

• Anders Hougaard, MD, Ph.d.

  Herlev Gentofte hospital, Department of Neurology,

  STUDY DIRECTOR

Central Study Contacts

Christina Kruuse, Professor

CONTACT

+45 3868 1233; christina.kruuse@regionh.dk

Rikke Steen Krawcyk, Ph.d

CONTACT

+45 3868 6159; rikke.steen.krawcyk@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: June 30, 2021
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: May 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)