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.
Parallel
Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®)
BehavioralTelehealth intervention involving the HEARTS technical package and the use of Smartwatch Mi Band 7® activity monitor. The HEARTS technical package presents the 5As brief intervention (Ask, Advise, Assess, Assist, Arrange) to promote physical activity participation. Participants will receive a physical activity monitor (as instructed in the HEARTS technical package) and will be monitored by telephone call, once a week, in order to reinforce successes and identify solutions to difficulties (as instructed in the HEARTS technical package) to practice physical activity. These individuals will undertake a 12-week intervention program. In the first week, individuals will perform the first four steps of the 5As brief intervention in person, where they will be instructed on how to use the physical activity monitor, they will receive a diary of regular physical activity practice, will be guided on how to fill it out, and will schedule the best times to receive the weekly telephone call.
Telehealth intervention: HEARTS technical package
BehavioralThe same intervention as the experimental group, but without the additional use of the physical activity monitor (Smartwatch Mi Band 7®).
Feasibility of recruitment
It will be determined by the ratio between the total number of eligible individuals (EI) and the total number of screened individuals (SI) (measure=EI/IS), and by the ratio between the total number of eligible individuals (EI) and the total number of recruited individuals (RI) (measure=EI/RI).
Feasibility of intervention (retention)
It will be determined by the ratio between the total number of individuals who completed the proposed intervention program and the total number of individuals who started the proposed intervention program.
Feasibility of intervention (follow-up of individuals)
It will be determined the ratio between the total number of individuals who remained in the same group to which they were initially allocated until follow-up and the total number of individuals who were allocated.
Feasibility of intervention (attendance)
It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered.
Physical activity level
Human Activity Profile (HAP). One of the outcomes provided by the instrument is the Maximum Activity Score (MAS). From the MAS, the Adjusted Activity Score (AAS) can be found by subtracting from the MAS the number of activities that the individual provided as the answer "I stopped doing". Higher scores indicate better outcome.
Number of post-stroke individuals who became physically active
Human Activity Profile (HAP). One of the measures provided by the questionnaire is the "Activity Rating", which provides an overall rating of the respondent's activity level into "Inactive", "Moderately active" and "Active".
Systolic and diastolic blood pressure
Tycos® aneroid sphygmomanometer (WelchAllyn Inc., NY, USA, Model DS44) and stethoscope (Litmann Classic II SE 3M®, USA).
Lifestyle-related energy consumption
Human Activity Profile (HAP). One of the measures provided by the questionnaire is the "Lifestyle-related energy consumption", which provides a measure of actual oxygen consumption estimated from the "Activity Adjusted Score" (AAS). This measure is operationalized in ml.kg-1.min-1. Higher scores indicate better outcome.
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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
