Stroke, IschemicNCT04332458
Motivators and Barriers for Physical Activity in Patients With Minor Stroke
A study testing A focus group interview in people with Stroke, Ischemic, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate motivators and barriers for physical activity in patients discharged from hospital for a minor stroke or TIA. The study has a qualitative research design and will be conducted by focus group interviews. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- A focus group interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 16 Jan 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with ischemic stroke or transient ischemic attack (TIA) without the need of a re-habilitation plan, but needs an exercise plan in order to prevent a recurrent stroke
- Patients who have participated in ≤ 1 hour of vigorous intensity activity on weekly basis within the last 3 months
- Patients able to speak, read, and understand Danish
- Patients ≥ 18 years of age and able to give informed consent
Who cannot join
- Patients with previous large artery stroke with sequelae preventing aerobic exercise in groups
- Symptoms or comorbidities preventing aerobic exercise in groups
- Dyspnoea caused by heart or lung diseases (e.g. chronic obstructive pulmonary disease (COPD))
- Aphasia or dementia interfering with participation in aerobic groups exercise
- Patients with Intermittent claudication/vascular claudication
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate motivators and barriers for physical activity in patients discharged from hospital for a minor stroke or TIA. The study has a qualitative research design and will be conducted by focus group interviews.
Read the detailed description
Little is known about motivators and barriers for physical activity after hospital discharge for patients with a minor stroke or TIA. These patients have few and temporary symptoms and are therefore discharged early from the hospital or seen in a outpatient TIA clinic. Standard treatment are preventive medication and advice on self-managed lifestyle changes. Occurrence of one ischemic stroke or TIA predisposes to further ischemic strokes and patients are at risk of developing cognitive deficits or vascular dementia over time unless multiple preventive measures are taken including physical activity. The purpose is to investigate motivators and barriers for physical activity after hospital discharge by focus-group interviewing this potential fragile group of patients. The research team want to facilitate the patients to be physically active and thereby prevent a recurrent stroke and slow the progression of vascular diseases.
- Conditions
- Stroke, Ischemic
- Being tested
- A focus group interview
- Keywords
- physical activity, motivators for physical activity, barriers for physical activity, secondary stroke prevention
- Medical subject headings
- Ischemic Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A focus group interviewBehavioural
this is a qualitative study using focus group interviewing.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stroke without exercise experience | Other | Patients who are discharged from the hospital within one month after a minor stroke or TIA and are not offered physical rehabilitation afterwards Receives: Behavioral: A focus group interview |
| Patients with stroke with exercise experience | Other | Patients with a minor stroke who have participated in an exercise study (HITPALS) Receives: Behavioral: A focus group interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivators for physical activity
The study has a qualitative research design using focus group interviewing
Measured: through study completion, an average of 1 year
Barriers for physical activity
The study has a qualitative research design using focus group interviewing
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Jun 2020
- Primary completion21 Mar 2021
- Study completion16 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Focus group interviewing a cohort of patients with stroke (one group with previous exercise experience and a group without)
- Masking
- None (open label)
- Enrolment
- 40 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, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332458
- Sponsor's protocol ID
- H-20014119
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant´s data cannot be shared with 3rd parties as these data are protected by Danish law
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivators and Barriers for Physical Activity in Patients With Minor Stroke
- ClinicalTrials.gov ID
- NCT04332458
- Acronym / sponsor ID
- H-20014119
- Conditions
- Stroke, Ischemic
- Keywords
- physical activity, motivators for physical activity, barriers for physical activity, secondary stroke prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 16 Jan 2022 (actual)
- First posted
- 2 Apr 2020 (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 investigate motivators and barriers for physical activity in patients discharged from hospital for a minor stroke or TIA. The study has a qualitative research design and will be conducted by focus group interviews.
Detailed description
Little is known about motivators and barriers for physical activity after hospital discharge for patients with a minor stroke or TIA. These patients have few and temporary symptoms and are therefore discharged early from the hospital or seen in a outpatient TIA clinic. Standard treatment are preventive medication and advice on self-managed lifestyle changes. Occurrence of one ischemic stroke or TIA predisposes to further ischemic strokes and patients are at risk of developing cognitive deficits or vascular dementia over time unless multiple preventive measures are taken including physical activity. The purpose is to investigate motivators and barriers for physical activity after hospital discharge by focus-group interviewing this potential fragile group of patients. The research team want to facilitate the patients to be physically active and thereby prevent a recurrent stroke and slow the progression of vascular diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Focus group interviewing a cohort of patients with stroke (one group with previous exercise experience and a group without)
| Arm | Type | Receives |
|---|---|---|
| Patients with stroke without exercise experience | Other | Behavioral: A focus group interviewPatients who are discharged from the hospital within one month after a minor stroke or TIA and are not offered physical rehabilitation afterwards |
| Patients with stroke with exercise experience | Other | Behavioral: A focus group interviewPatients with a minor stroke who have participated in an exercise study (HITPALS) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ischemic stroke or transient ischemic attack (TIA) without the need of a re-habilitation plan, but needs an exercise plan in order to prevent a recurrent stroke
- Patients who have participated in ≤ 1 hour of vigorous intensity activity on weekly basis within the last 3 months
- Patients able to speak, read, and understand Danish
- Patients ≥ 18 years of age and able to give informed consent
Key exclusion criteria (5 listed)
- Patients with previous large artery stroke with sequelae preventing aerobic exercise in groups
- Symptoms or comorbidities preventing aerobic exercise in groups
- Dyspnoea caused by heart or lung diseases (e.g. chronic obstructive pulmonary disease (COPD))
- Aphasia or dementia interfering with participation in aerobic groups exercise
- Patients with Intermittent claudication/vascular claudication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A focus group interviewthis is a qualitative study using focus group interviewing. | Behavioural | Patients with stroke with exercise experience, Patients with stroke without exercise experience |
Primary outcome
Motivators for physical activity
Time frame: through study completion, an average of 1 year
The study has a qualitative research design using focus group interviewing
Barriers for physical activity
Time frame: through study completion, an average of 1 year
The study has a qualitative research design using focus group interviewing
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 5 Apr 2022.
- Individual participant dataSharing planned: No. Individual participant´s data cannot be shared with 3rd parties as these data are protected by Danish law
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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, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A focus group interview in people with Stroke, Ischemic, 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 5 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 5 Apr 2022. 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?
Motivators for physical activity (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 5 Apr 2022.