Fit 4 Me After Stroke (Mild)

Not Applicable

Recruiting

Conditions: Stroke
Stroke - Ischaemic
Stroke - Haemorrhagic

Registration Number: ACTRN12622001083785

Lead Sponsor: The University of Melbourne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

• Stroke survivors (first or recurrent) within 6 months of most recent stroke
• Adults (18 years years or older)
• Able to ambulate unassisted with or without an aid
- Gait speed equal or faster than 0.8m/s unassisted (mild cohort)

• Able to provide informed consent (with communication support if necessary; aphasia-friendly consent forms available)

Exclusion Criteria

• Unable to ambulate without physical assistance of another person
• Gait speed slower than 0.8 m/s
• Live greater than 2 hours from the University of Melbourne – as this will affect feasibility of assessments
• Concurrent palliative diagnosis, dementia or other diagnosis that may preclude participation in a physical activity program and study components.
• Severe communication or cognitive difficulties that preclude participation in a physical activity program and study components.
• Medical clearance not provided. Form to be completed by the participants’ general practitioner, or other medical specialist (e.g., neurologist, rehabilitation specialist, cardiologist).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Primary Outcome is the DESIRABILITY OF A DOSE at 8 weeks quantified using UTILITY which is the efficacy/dose limiting trigger (DLT) trade-off where:<br><br>- Efficacy is greater than or equal to 20% improvement in average daily step count (measured over 7 days with a Fitbit Inspire 2 activity monitor)<br><br>- Absence of DLTs is defined as both adherence to physical activity intensity and duration dose (within 10%, assessed via an activity diaries and an actigraph device) and no serious intervention-related adverse event.<br><br>The safety or tolerance aspect DLT aspect of utility is discomfort/fatigue that limit physical activity at the prescribed dosage or impact ability to carry out regular daily tasks. Fatigue and discomfort following sessions that do not limit participation (i.e., are not dose-limiting) will not impact that dose escalation/de-escalation schedule.[ 8 weeks after the initial program set-up session<br>(Step count is also measured at baseline)]

Secondary Outcome Measures