Sitting Time AfteR Stroke (STARS). A phase II safety and feasibility trial of counselling sessions aimed at encouraging stroke survivors to 'move more and sit less'.
Not Applicable
Completed
- Conditions
- Inactivity in community-dwelling stroke survivors.Stroke - IschaemicStroke - Haemorrhagic
- Registration Number
- ACTRN12612000958886
- Lead Sponsor
- School of Health Sciences, University of South Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Stroke survivors with last stroke occurring at least 6 months previously.
Living in the community for at least 2 months
Able to walk independently (with or without walking aid) around the house
Sufficient cognitive, language and hearing ability to participate in counseling sessions both face to face and over the phone.
Exclusion Criteria
Other major co-morbidities significantly affecting mobility
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Participants will be questioned about any falls they had during the intervention period (number and details of falls - what they were doing at the time of the fall and injuries incurred).[End trial (post-intervention) at 10 weeks]
- Secondary Outcome Measures
Name Time Method The primary feasibility outcome is motivational interviewing (MI) fidelity (mean 95% of utterances per counseling sessions rated as MI consistent).[End trial (post-intervention) at week 10];Changes in self-reported fatigue (safety) using the Checklist Individual Strength - subscale fatigue (CIS-f).[End trial (post-intervention) at week 10];Other adverse events such as self-reported increases in pain, skin reactions to monitors (safety)[End trial (post-intervention) at week 10];Compliance with wearing activity monitors (feasibility) - number of valid wear days for each monitor for each participant[End trial (post-intervention) at week 10]