Overview
Background: Stroke secondary prevention guidelines point out that post-stroke individuals often present sedentary or inactive behavior and, therefore, should be encouraged to practice physical activity. Behavior change interventions, such as to encourage physical activity practice, must be theoretically informed and can be implemented remotely. However, systematic reviews about telehealth interventions do not consolidate evidence regarding the use of these interventions to promote physical activity with post-stroke individuals.
Objectives: The primary aim of this study is to investigate the effect of telehealth intervention involving the HEARTS technical package and the use of an activity monitor to promote physical activity with post-stroke individuals. The secondary aim of this study is to investigate the effect of the previously mentioned intervention in reducing systolic and diastolic blood pressure, increasing lifestyle-related energy consumption, improving self-efficacy for physical activity and health-related quality of life of post-stroke individuals.
Design: A randomized controlled trial 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 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. Measurements will be performed at baseline (week 0), after the end of the intervention program (week 12) and one month after the end of the intervention program (week 16).
Study Outcomes: Primary outcome is the physical activity level and the number of individuals post-stroke who became physically active. Secondary outcomes are systolic and diastolic blood pressure, lifestyle-related energy consumption, self-efficacy for physical activity and health-related quality of life.
Conclusion: The results of this trial will provide valuable new information on the effect of the previously mentioned intervention to promote physical activity with post-stroke individuals, as well in reducing systolic and diastolic blood pressure, increasing lifestyle-related energy consumption, improving self-efficacy for physical activity and health-related quality of life of these individuals.
Description
Sample size calculation: Teixeira-Salmela et al. (1999) investigated the effect of muscle strengthening and physical conditioning to reduce impairment and disability in post-stroke individuals and used the Adjusted Activity Score (AAS) of the Human Activity Profile (HAP) to assess the physical activity level. Considering a significance level of 5%, a desired power of 80%, a difference in means post intervention between experimental e control group for AAS of 11.93 and a standard deviation of this outcome variable of 10.03, and an expected dropout rate of 30%, the minimum number of participants needed was 17 participants per group (total of 34).
Statistical analyzes: All statistical analyzes will be performed by an independent examiner, blinded to the group allocation. Each participant will assign with a unique code. All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). The normality of data distribution will be performed for all continuous numeric variables. Descriptive statistics will be calculated for all outcomes. The effects of the interventions will be analyzed from the collected data using intention-to-treat. Data from the last available assessment will be used for missed sessions. Two-way ANOVA with repeated measures (2*3) will be used to evaluate the differences between groups, considering the time factor (considering baseline, post-intervention, and 4-week follow-up) for the variables of interest. The level of significance will be set at 5% and adjusted for multiple comparisons. The effect sizes will be calculated to determine the magnitude of the differences between the groups.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.