NCT04332458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

March 30, 2020

Last Update Submit

April 4, 2022

Conditions

Keywords

physical activitymotivators for physical activitybarriers for physical activitysecondary stroke prevention

Outcome Measures

Primary Outcomes (2)

  • Motivators for physical activity

    The study has a qualitative research design using focus group interviewing

    through study completion, an average of 1 year

  • Barriers for physical activity

    The study has a qualitative research design using focus group interviewing

    through study completion, an average of 1 year

Study Arms (2)

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

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)

Behavioral: A focus group interview

Interventions

this is a qualitative study using focus group interviewing.

Patients with stroke with exercise experiencePatients with stroke without exercise experience

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Copenhagen, Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Ischemic StrokeMotor Activity

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • christina Kruuse, Professor

    Herlev Gentofte Hospital, Department of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
none of the participants are blinded in the focus group interview
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Focus group interviewing a cohort of patients with stroke (one group with previous exercise experience and a group without)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 2, 2020

Study Start

June 1, 2020

Primary Completion

March 21, 2021

Study Completion

January 16, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Individual participant´s data cannot be shared with 3rd parties as these data are protected by Danish law

Locations