Effects of a multidisciplinary intervention to promote physical activity in patients with stroke undergoing rehabilitation: study protocol for the ActivePAS pilot randomised controlled trial

INTRODUCTION: Physical activity after stroke is related to functional recovery and outcomes. To optimise physical activity adapted to a patient’s walking ability and characteristics, multidisciplinary support and interventions are required. The Activate Physical Activity for Stroke pilot randomised controlled trial aims to assess the safety and feasibility of a multidisciplinary intervention that promotes physical activity in patients who had a stroke undergoing rehabilitation. METHODS AND ANALYSIS: This single-centre, randomised controlled trial will enrol 32 patients who had a stroke undergoing rehabilitation. Patients who had a stroke with the ability to walk 50 m with at least hand assistance, regardless of the use of braces or walking aids, and aged≥20 years will be randomly allocated to a multidisciplinary intervention group or control group. Patients in the intervention group will receive instructions for the self-monitoring of hospitalised physical activity and support to promote physical activity by multidisciplinary staff. The primary outcome of the present study is the safety (adverse events) and feasibility (retention and completion rates) of the multidisciplinary intervention. We assess physical activity using a triaxial accelerometer (UW-204NFC, A&D Company) as one of the secondary outcomes. ETHICS AND DISSEMINATION: The present study has been approved by the Research Ethics Committee of Konan Women’s University and the Ethics Committee of Nishi-Kinen Port Island Rehabilitation Hospital. We will disseminate the results of the present study through a peer-reviewed manuscript and presentations at international conferences. TRIAL REGISTRATION NUMBER: UMIN000046731.