Clinical trial NCT05051111: Pre-stroke Physical Activity in Patients With Stroke
Official title: Pre-stroke Physical Activity in Patients With Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Physical activity
Stroke
Questionnaire
Patient reported outcome measure
Inpatient
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be enrolled consecutively during their hospitalisation for a stroke.

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.

Detailed description: Physical inactivity and low cardiorespiratory fitness are important risk factors for stroke. To design future secondary non-pharmacological prevention strategies in stroke, detailed information on current level of physical activity is essential.

In the Danish adult population, 28,8% do not adhere to the WHO guidelines on physical activity for health, with an increasing number (33%) in the population older than 55 years of age. Diverging results have been given on level of physical activity in patients with stroke which warrants further investigation.

Statistics: Descriptive statistics will be used to characterise the study population. To evaluate whether the participants adhere to recommendations on physical activity the proportion of participants adhering will be estimated. To evaluate the association between pre-stroke physical activity using MET-values (dependent variable) and sociodemographic variables (age, gender, previous event of stroke, subtypes of stroke, cardiovascular risk factors, living status and educational level) a multiple linear regression analysis will be performed. The aim is to include 120 participants in the multiple linear regression analyses. This is based on the number of variables (a maximum of seven). p \< 0.05 will be used as level of statistical significance. All tests will be two-sided. Data will be analysed using Microsoft Excel 2019 and Stata 17.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Physical Activity
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Gentofte Hospital
Study officials:
affiliation: Herlev Gentofte Hospital, Dept. of Neurology
name: Christina Kruuse, Professor
role: PRINCIPAL_INVESTIGATOR
References: