Actively Recruiting
The Adaptive Physical Activity Study for Stroke
Led by University of Limerick ยท Updated on 2024-05-29
117
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Despite recent advances in acute stroke intervention, secondary prevention strategies are lacking. Physical activity (PA) is the second largest predictor of stroke and the cornerstone of secondary prevention therapies. Adaptive interventions involve sequential treatments responsive to individuals' performance. Despite guidelines to adapt PA to individuals' needs, there is no evidence on the empirical development of adaptive PA interventions post-stroke. The evidence is dominated by standard trial designs, used to evaluate non-adaptive PA interventions. This trial will make original contributions to the literature by designing a first-in-class adaptive PA intervention using an innovative experimental design. This design will permit the delivery of optimal sequences of treatments to increase PA for individuals. Furthermore, by developing a user-informed smartphone application, this feasibility trial will lead to the design and evaluation of a highly-scalable definitive intervention to reduce the risk of recurrent stroke. Aim To use a Sequential Multiple-Assignment Randomised Trial (SMART) design to develop an adaptive, user-informed mobile health (mHealth) intervention to improve PA post-stroke. Subsequently this adaptive intervention will be evaluated against a treatment-as-usual control using a standard trial design in a definitive trial. Methods A co-design process was used to develop the technology platform for intervention delivery. There are two components which target increased PA in the current intervention: Structured Exercise and Lifestyle PA. The SMART will determine what sequence and/or combination of these intervention components produces the greatest increase in physical activity as measured by average daily step count. The primary outcome will be PA (steps/day), with clear feasibility and secondary clinical and cost outcomes. A SMART design will be used to evaluate the optimum adaptive PA intervention among people post-mild-to-moderate stroke.
CONDITIONS
Official Title
The Adaptive Physical Activity Study for Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Clinician-confirmed stroke (ischaemic or haemorrhagic subtype)
- Living within 90 kilometers of University
- Within the first 6 months post-stroke
- No longer receiving inpatient, outpatient, or community-based physical activity rehabilitation
- Modified Rankin Scale score of 0-3
- Able to express basic needs verbally
- Access to technology for mobile health intervention delivery
- Cognitive ability to provide informed consent
- Medical clearance for participation in the TAPAS program
You will not qualify if you...
- Contraindications for physical activity, such as safety concerns or unstable heart disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Limerick
Limerick, Limeick, Ireland, V94P7X9
Actively Recruiting
Research Team
S
sara hayes, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here