NCT05051111

Brief Summary

The aim of this study is to explore the level of pre-stroke physical activity in patients with stroke and to investigate associations between physical activity and sociodemographic variables, e.g. history of stroke, co-morbidities and subtype of stroke. Physical inactivity is a great risk factor for stroke; thus, the investigators hypothesise that patients hospitalised with stroke will present with a lower level of pre-stroke physical activity than recommended by World Health Organization (WHO) guidelines on physical activity for health. Additionally, the investigators expect to find an association between pre-stroke physical activity and specific sociodemographic variables, e.g. stroke subtype, and re-stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 23, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

September 9, 2021

Last Update Submit

February 23, 2024

Conditions

Keywords

Physical activityStrokeQuestionnairePatient reported outcome measureInpatient

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    Measured by a self-reported questionnaire, the Physical Activity Scale (PAS2), consisting of nine questions: Six measuring daily hours and minutes of sleep, work (sitting down, standing/walking and heavy physical activities), active transport and sedentary behaviour during leisure time, and three questions measuring weekly hours and minutes during leisure time at three intensities (light, moderate and vigorous)). Each question corresponds to a specific level of metabolic equivalent of task (MET). The total measurement will provide an estimation of a daily MET-score.

    The measurement will be performed between day 1 and day 7 of hospitalisation. The questionnaire evaluate the participants´ habitual physical activity level two weeks prior to hospitalisation.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants will be enrolled consecutively during their hospitalisation for a stroke.

You may qualify if:

  • Clinical symptoms of acute stroke, verified by a neurologist with diagnosis of stroke (intracerebral haemorrhage, cerebral infarction, "stroke, not specified as haemorrhage or infarction" or transient ischemic attack (TIA)).
  • Acute/subacute stroke or TIA verified on MRI-scan or CT-scan.
  • Able to speak, read and understand Danish.
  • Able to provide informed consent, including being awake, alert and oriented (personal data, place, and time).

You may not qualify if:

  • Aphasia that hinders responding to the PAS2.
  • Cognitive deficits that hinder responding to the PAS2 (Mini-Mental State Examination-score (MMSE) ≤ 23, diagnosis of dementia at hospital admission).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Gentofte Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Christina Kruuse, Professor

    Herlev Gentofte Hospital, Dept. of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Ph.d., MSci, MD

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 21, 2021

Study Start

September 23, 2021

Primary Completion

February 21, 2022

Study Completion

December 31, 2022

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations