The Adaptive Physical Activity Study for Stroke

Summary

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

• Stroke

Interventions

BEHAVIORAL

Structured Exercise

Participants assigned to Structured Exercise will be provided with twice weekly strengthening exercise classes, delivered through the digital platform. The exercise classes will follow a circuit class style, in order to target a moderate-vigorous exercise intensity. Classes will gradually progress in intensity throughout the program. Classes will include a full body warm up followed by a circuit of eight strengthening exercises. This will be repeated for increasing sets and adding resistance through the use of resistance bands . Exercises will involve simple full body exercises and movements for each major muscle group. This will ensure that exercises that can be completed regardless of possible unilateral weakness or physical impairment. During each session, participants will be reminded to reach their targeted weekly step count goals. The structured exercise component is informed by international clinical guidelines (Kleindorfer et al 2021 and Billinger et al 2021).

BEHAVIORAL

Lifestyle Physical Activity

The Lifestyle PA component was developed using the Behaviour Change Wheel (BCW) Guide to Designing Interventions and is underpinned by the COM-B model of behavior change (Michie et al., 2014). This posits that people need capability(C), opportunity(O), and motivation(M) to perform a behavior(B). The aim of the Lifestyle PA component is to increase the capability, opportunity, and motivation of participants to reach their daily step count goals. To achieve this the 3 stages of the BCW intervention design process were followed. The first stage, understanding the behaviour, is done through a review of the literature and primary qualitative research(Cardy et al., 2022). This stage identifies the change objectives of the intervention. Stage 2 requires the selection of intervention functions and the policies that would support them. The final stage is defining the content of the intervention using behaviour change techniques (BCTs) and selecting their mode of delivery.

Sponsors & Collaborators

• University of Limerick

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2025-01-31

Completion

2025-01-31

Countries

• Ireland

Study Locations