RESUMO
BACKGROUND: A Phase I study showed that it is feasible to implement a home-based self-management program aimed at increasing physical activity in individuals after stroke with mild walking disability in Brazil. The next step is to test this program against a control group in order to provide a power analysis for a fully-powered Phase III clinical trial. METHODS: A Phase II pilot randomised clinical trial with concealed allocation, blinded measurement, and intention-to-treat analyses will be carried out. The inclusion criteria will be individuals diagnosed with stroke, in the acute or subacute phase, with mild walking disability, sedentary, and no significant language impairment. The participants will be randomly allocated to the experimental or control group. The experimental group will receive six sessions of a home-based self-management program based on behaviour change techniques through the Social-Cognitive Theory and Control Theory over 11 weeks. The control group will receive one session of education about stroke (regarding the importance of practising physical activity after a stroke) and usual care. A total of 24 participants will be recruited. The primary outcome will be physical activity, measured through steps taken per day by an activity monitor (Actigraph wGT3X-BT, Pensacola, FL, USA). The mean of daily steps will be analysed to compare groups after intervention. Secondary outcomes will be cardiovascular risk (body mass index, waist circumference, and blood pressure), depressive symptoms (Geriatric Depression Scale), walking ability (6-Minute Walk Test and 10-Meter Walk Test), exercise self-efficacy (Self-Efficacy for Exercise scale), social participation (Stroke Impact Scale) and quality of life (EuroQual-5D). Two-way analyses of variance will be implemented for all parametric outcomes, and the Kruskal-Wallis test for non-parametric outcomes will be used to determine the statistical significance of the between-group differences and reported as mean differences between groups (95% CI). All analyses will be conducted intention-to-treat. All outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). This pilot clinical trial was registered online at Clinical Trials under number NCT05461976 on 4th April 2022. DISCUSSION: If beneficial, this Phase II pilot randomised trial will provide data to plan a fully powered future Phase III clinical trial aimed at verifying the efficacy of this program to promote physical activity after stroke. TRIAL REGISTRATION: Clinical Trials NCT05461976 on 4th April 2022.
Assuntos
Autogestão , Acidente Vascular Cerebral , Idoso , Humanos , Ensaios Clínicos Fase II como Assunto , Terapia por Exercício/métodos , Projetos Piloto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , CaminhadaRESUMO
Objective: To investigate the sleep state and determine whether variables, such as age, functional status, walking capacity, fatigue, depressive symptoms, and quality of life were associated with sleep quality of individuals with chronic stroke.Methods: For this exploratory study, the dependent variable was sleep quality, which was measured by the Pittsburgh Sleep Quality Index (PSQI). Step-wise multiple linear regression analysis was employed to identify which of the independent variables, that is, age, functional status (Modified Rankin Scale-mRS), walking capacity (6-minute Walk Test), fatigue (Fatigue Severity Scale), depressive symptoms (Geriatric Depression Scale-GDS), and quality of life (EuroQol) were associated with sleep quality.Results: Ninety participants, 55 (61%) men, who had a mean age of 61 (SD 12) years and a mean time since the onset of the stroke of 58.2 (SD 58.7) months, were included. Sleep quality was significantly associated with depressive symptoms and functional status. Together, they explained 30% of the variance in the PSQI scores (p < .0001). The GDS scores alone explained 22% (F = 25.76; p < .0001) of the variance in sleep quality (PSQI). When mRS scores were included in the model, the explained variance increased to 30% (F = 20,38; p < .0001).Conclusion: Depressive symptoms and functional status, which are both potentially modifiable factors, were associated with the sleep quality of individuals with chronic stroke. It is important to consider the assessment of sleep quality in the context of stroke rehabilitation.
Assuntos
Depressão , Acidente Vascular Cerebral , Idoso , Depressão/etiologia , Estado Funcional , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Sono , Acidente Vascular Cerebral/complicaçõesRESUMO
OBJETIVO: Avaliar o desenvolvimento de crianças de 2 meses a 2 anos de idade por meio da Atenção Integrada às Doenças Prevalentes na Infância (AIDPI), no contexto do Programa de Educação pelo Trabalho em Saúde (PET-Saúde). MÉTODO: Estudo transversal realizado com 122 crianças, com idades entre 2 meses e 2 anos, da área de abrangência do Centro de Saúde São Bernardo (CSSB) - Belo Horizonte (MG), em 2009. Os dados relativos ao desenvolvimento foram obtidos através da aplicação de dois questionários: AIDPI e Caderneta de Saúde da Criança (CSC). Foram comparadas as classificações do desenvolvimento pela AIDPI e pela CSC, a associação entre atraso do desenvolvimento e as variáveis estudadas. RESULTADOS: As características com maior frequência na população estudada foram a baixa escolaridade das mães (62,1%), seguida de parentes com deficiência mental (71,3%) e problemas na gestação (71,3%). A AIDPI evidenciou que 61,5% da população estudada encontra-se normal com fator de risco, 16,4% normal sem fator de risco, 11,5% com possível atraso e 10,7% com provável atraso do desenvolvimento infantil. A concordância observada entre a classificação da AIDPI e da CSC foi de 0,34, coeficiente Kappa igual a - 0,12 (p = 0,98). Não houve associação estatisticamente significativa entre as variáveis analisadas (frequenta creches; convívio com problemas emocionais; escolaridade da mãe; idade gestacional; e peso ao nascer) e atraso possível/provável do desenvolvimento identificado pela AIDPI. CONCLUSÃO: O PET-Saúde, como proposta de integração da educação pelo trabalho, permitiu uma oportunidade de convivência e troca de experiências entre alunos e profissionais de diferentes áreas de atuação, trabalhando em um projeto comum.
OBJECTIVE: The aim of this study was to evaluate early childhood development, from two months to two years of age, based on Integrated Management of Childhood Illness, IMCI (or AIDPI in Portuguese) in the context of the Educational Program for Health Work (PET-Saúde). METHODS: A cross-sectional study was conducted with 122 children two months to two years of age from the coverage area of the São Bernardo Health Center in Belo Horizonte, Minas Gerais State, in 2009. Data on the children´s development were obtained using two questionnaires: IMCI and the Children's Health Booklet (CSC in Portuguese). Early childhood development according to the IMCI classification was compared to the results with CSC. The authors also investigated potential associations between independent variables and developmental delay. RESULTS: The most frequent characteristics in the study population were low maternal schooling (62.1%), followed by relatives with mental disability (71.3%), and problems during the pregnancy (71.3%). Based on the IMCI classification, 61.5% of the study population was normal with some risk factor, 16.4% normal without any risk factor, 11.5% with possible delay, and 10.7% with probable childhood developmental delay. Agreement between the IMCI and CSC classifications was 0.34, kappa index - 0.12 (p = 0.98). There was no statistically significant association between the variables (daycare attendance; contact with emotional problems; maternal schooling; gestational age; and birth weight) and possible or probable early childhood developmental delay according to the IMCI classification. CONCLUSION: PET-Saúde, as a proposal for integration between education and work, provided an opportunity for contact and exchange of experiences between students and health professionals from various fields, working in a common project.