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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
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 30, 2020
Last Updated
April 4, 2022
Sponsor
Herlev Hospital
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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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