StrokeNCT05051111
Pre-stroke Physical Activity in Patients With Stroke
An observational study of Stroke, run by Herlev Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 123 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Sep 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be enrolled consecutively during their hospitalisation for a stroke.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- Physical activity, Stroke, Questionnaire, Patient reported outcome measure, Inpatient
- Medical subject headings
- Stroke, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start23 Sep 2021
- Primary completion21 Feb 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Kruuse, Herlev Hospital
- Investigators
- Christina Kruuse, Professor, Principal investigator, Herlev Gentofte Hospital, Dept. of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051111
- Sponsor's protocol ID
- 21054586
- Status last verified
- Feb 2024
- First submitted
- 9 Sep 2021
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-stroke Physical Activity in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05051111
- Acronym / sponsor ID
- 21054586
- Conditions
- Stroke
- Keywords
- Physical activity, Stroke, Questionnaire, Patient reported outcome measure, Inpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be enrolled consecutively during their hospitalisation for a stroke.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical Activity
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Kruuse, Professor principal investigator
Herlev Gentofte Hospital, Dept. of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.