Objectives: The aim of this feasibility randomized controlled trial (RCT) study is to investigate whether the theoretically informed telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke is feasible and to estimate the parameters for conducting a fully powered RCT.
Design: A Phase 1 feasibility RCT study with blinded assessment will assign eligible participants to experimental or control group. Participants in both groups will undergo a theoretically informed telehealth intervention based on the HEARTS technical package (a face-to-face session and telephone call follow-up). The experimental group will have additional use of the Mi Band 7® Smartwatch activity monitor. For both groups, the intervention will last for 12 weeks. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting.
Study Outcomes: Feasibility of recruitment, intervention, and measurement, and clinical outcomes.
Conclusions: Results from this feasibility RCT study will inform on the design and sample required for a fully powered RCT with a similar aim.
Diagnosis of stroke for more than six months;
≥18 years of age;
Be rated as "Inactive" according to Human Activity Profile (HAP);
Provide medical approval to practice physical activity.
Positive screening test for possible cognitive alterations;
Pain or other adverse health condition that compromises the performance of the proposed intervention program, such as vestibular disorders, severe arthritis or any other diagnosis of disease of the nervous system.
Federal University of Minas Gerais
Lead sponsor
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Collaborator
Worldwide Universities Network
Collaborator