Motivators and Barriers for Physical Activity in Patients With Minor Stroke
Primary Purpose
Stroke, Ischemic
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
A focus group interview
Sponsored by
About this trial
This is an interventional prevention trial for Stroke, Ischemic focused on measuring physical activity, motivators for physical activity, barriers for physical activity, secondary stroke prevention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Herlev Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients with stroke without exercise experience
Patients with stroke with exercise experience
Arm Description
Patients who are discharged from the hospital within one month after a minor stroke or TIA and are not offered physical rehabilitation afterwards
Patients with a minor stroke who have participated in an exercise study (HITPALS)
Outcomes
Primary Outcome Measures
Motivators for physical activity
The study has a qualitative research design using focus group interviewing
Barriers for physical activity
The study has a qualitative research design using focus group interviewing
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04332458
Brief Title
Motivators and Barriers for Physical Activity in Patients With Minor Stroke
Official Title
Motivators and Barriers for Physical Activity in Patients With Minor Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
March 21, 2021 (Actual)
Study Completion Date
January 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
physical activity, motivators for physical activity, barriers for physical activity, secondary stroke prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
none of the participants are blinded in the focus group interview
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with stroke without exercise experience
Arm Type
Other
Arm Description
Patients who are discharged from the hospital within one month after a minor stroke or TIA and are not offered physical rehabilitation afterwards
Arm Title
Patients with stroke with exercise experience
Arm Type
Other
Arm Description
Patients with a minor stroke who have participated in an exercise study (HITPALS)
Intervention Type
Behavioral
Intervention Name(s)
A focus group interview
Intervention Description
this is a qualitative study using focus group interviewing.
Primary Outcome Measure Information:
Title
Motivators for physical activity
Description
The study has a qualitative research design using focus group interviewing
Time Frame
through study completion, an average of 1 year
Title
Barriers for physical activity
Description
The study has a qualitative research design using focus group interviewing
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
christina Kruuse, Professor
Organizational Affiliation
Herlev Gentofte Hospital, Department of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Copenhagen
State/Province
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant´s data cannot be shared with 3rd parties as these data are protected by Danish law
Learn more about this trial
Motivators and Barriers for Physical Activity in Patients With Minor Stroke
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