Effects of an Exercise and Lifestyle Education Program in Brazilians living with prediabetes or diabetes: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Patient education is a crucial strategy for promoting prevention and diabetes self-management since glycemic control achievement involves taking medications, medical nutrition therapy, physical exercise, and behavior changes. However, patient education programs are still barely implemented in low- and middle-income countries. This trial aims to investigate whether a lifestyle education intervention added to physical exercising is superior to sole physical exercising regarding functional capacity, disease-related knowledge, health behaviors, cardiometabolic health parameters, quality of life, depression, and diet quality in individuals with prediabetes or diabetes. METHODS: Multicenter double-blinded randomized controlled trial with two parallel arms involving 12-week intervention and 6-month follow-up. The eligible individuals (≥ 18 years, living with prediabetes or diabetes, literate, no clinical decompensation and/or physical and/or mental limitations that contraindicate physical exercising, written physician permission for exercise, no cognitive impairment, no vision limitations for reading, no confirmed diagnosis of unstable coronary disease or heart failure, no pacemaker and/or implantable cardioverter-defibrillator, no complex ventricular arrhythmias, no intermittent claudication, no recent cardiovascular event or cardiac surgery, and no currently enrolled in a structured exercise program) were recruited from two Brazilian cities and randomized to either (1) an Exercise and Lifestyle Education Program (ExLE) or (2) an Exercise Program (Ex), which can be delivered on-site or remotely based on the participants' internet access and technology literacy. The primary outcomes will be changes in functional capacity and disease-related knowledge. The secondary outcomes will involve changes in health behaviors (health literacy, physical activity level, exercise self-efficacy, and medication adherence) and cardiometabolic health parameters (glycemic control, anthropometric measures, and cardiac autonomic control). Program adherence, satisfaction with the program, diabetes-related morbidity, and changes in quality of life, depression, and diet quality will be the tertiary outcomes. Assessments will occur at baseline, post-intervention, and after 6-month follow-up. DISCUSSION: If superior effectiveness of ExLE compared to Ex program to improve the outcomes measures is found, this program could be delivered broadly in the Brazilian health system, especially in the primary care facilities where most individuals living with prediabetes and diabetes in our country are assisted. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03914924 . Registered on April 16, 2019.

Effects of exercise training parameters on cardiorespiratory fitness of individuals with type 2 diabetes mellitus: a systematic review and meta-analysis.

Purpose: To assess the effects of exercise training parameters on cardiorespiratory fitness of individuals with type 2 diabetes mellitus (T2DM). Methods: This systematic review was registered on PROSPERO (CRD42020210470). Searches were performed on PubMed, PEDro EMBASE, MEDLINE (Ovid), LILACS, PsycINFO, SCIELO, CINAHL, and Cochrane Library. The primary outcome was cardiorespiratory fitness, defined as maximal oxygen uptake (VO2max) during a maximal or submaximal exercise test. Two independent reviewers extracted data and assessed the risk of bias. Data were pooled using a random effects model and expressed as mean difference (MD) and 95% confidence interval (95%CI). Heterogeneity (I2) was assessed using Cochran's Q test. The risk of bias and quality of evidence was assessed using the Cochrane risk of bias tool and GRADE. Results: Twenty-two studies comparing exercise and control groups were included. The risk of bias indicated some concerns in most studies, and the quality of evidence was rated very low. Interventions with moderate (MD = 1.91, 95%CI = .58 to 3.34) and progressive exercise intensity (MD = 2.70, 95%CI = 2.43 to 2.96) and volume (MD = 1.72, 95%CI = .59 to 2.85) showed greater improvements in VO2max. Conclusions: Protocols that progressively increased exercise training parameters improved the cardiorespiratory fitness response. Progressive exercise might be more suitable for individuals with T2DM. Our conclusion may be limited due to the very low quality of evidence. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01205-5.

Exercise and Lifestyle Education program for Brazilians living with prediabetes and diabetes: A pilot randomized trial.

AIMS: To test the Diabetes College Brazil Study feasibility, the acceptability of study interventions and their preliminary effectiveness, and describe the study protocol modifications due to the COVID-19 pandemic. METHODS: Single-center, double-blinded pilot randomized trial with two parallel groups, Exercise and Lifestyle Education (ExLE; 12-week exercise and educational interventions) and Exercise (Ex; 12-week exercise intervention only) involving patients with prediabetes or diabetes. Feasibility (eligibility, recruitment, retention, completeness of variables measures and participation rates), acceptability (satisfaction), and preliminary effectiveness of interventions (variables: functional capacity, physical activity (PA), exercise self-efficacy, diabetes knowledge, health literacy, adherence to Mediterranean food pattern, glycated hemoglobin (HbA1c), anthropometric measures, cardiac autonomic control, depression, and quality of life (QofL)). RESULTS: Eligibility, recruitment, retention, participation in exercise sessions, and education classes rates were 17%, 93%,82%, 76%, and 71%, respectively. Missing data in the post-intervention assessment (PA, HbA1c, cardiac autonomic control, anthropometric measures, depression, and QofL) were mainly related to research procedure modifications. The interventions were highly acceptable, and most variables improved farther in the ExLE, with moderate effect sizes for PA, diabetes knowledge, health literacy, cardiac autonomic control, and QofL. CONCLUSIONS: The Diabetes College Brazil Study is feasible, and the ExLE may benefit Brazilians living with prediabetes and diabetes.

Feasibility of Remote Delivering an Exercise and Lifestyle Education Program for Individuals Living with Prediabetes and Diabetes in Brazil.

This study aimed to test the feasibility of remote delivering a 12-week exercise and lifestyle education program (ExLE) or a 12-week exercise program (Ex) for individuals with prediabetes and diabetes in terms of acceptability, implementation, practicality, and limited efficacy. The programs were internet- or telephone-based delivered, depending on the participants' internet access and technology literacy. Of the 196 individuals screened, 15 were included in the study (internet-based delivery (n = 13); telephone-based delivery (n = 2)). Twelve participants completed the program they were randomized to, and most reported being satisfied with the study interventions (acceptability). Data collection procedures, weekly follow-up, study website visits, and educational materials were proper (implementation), and the adherence rate to study interventions ranged from 24% to 58% (practicality). Additionally, both programs (ExLE and Ex) seemed to promote beneficial changes in functional capacity (limited efficacy). The internet-based remote delivery of the interventions showed feasibility. Therefore, in future trials, exercise and educational interventions can be internet-based remote delivered to individuals with prediabetes and diabetes with internet access and technology literacy. In addition, some adjustments to eligibility criteria, study websites, more accessible ways of recording exercise sessions and using educational materials, and an initial supervised exercise session are recommended.

Behavior change interventions in patients with type 2 diabetes: a systematic review of the effects on self-management and A1c.

PURPOSE: This study aimed to identify the characteristics of interventions employed to promote behavior change in people with type 2 diabetes mellitus (T2DM) and their impact on disease self-management and glycated hemoglobin (A1c). METHODS: The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were used to guide the protocol development for this systematic review. Randomized controlled clinical trials which compared behavior change interventions to controls in adults with T2DM and investigated disease self-management and glycated hemoglobin (A1c) measured by validated methods were eligible for this study. The risk of bias and quality of evidence was assessed respectively by Cochrane's tool and grading of recommendations, assessment, development, and evaluation (GRADE). RESULTS: A total of 27 studies were included involving 4464 participants. Behavior change was mainly promoted by education sessions on diabetes care delivered face-to-face, monthly, or every other month, lasting more than 60 min, involving blood glucose monitoring, healthy eating, exercise, and medication. Four studies showed significant improvement in both disease self-management and A1c. The risk of bias was classified as high in most studies. A meta-analysis could not be performed for A1c and self-management due to the high differences in intervention parameters (delivery mode, number, duration, and frequency) and self-management assessments. CONCLUSION: Low evidence of improvement in disease self-management and A1c considering only validated assessment methods were found for behavior change interventions, mainly promoted by education sessions on diabetes care. The quality of studies and probably the differences in intervention protocols contributed to this finding. PROSPERO NUMBER: CRD42020161162.

Translation, cross-cultural adaptation, and psychometric properties of the Brazilian Portuguese version of the DiAbeTes Education Questionnaire (DATE-Q).

BACKGROUND: The DiAbeTes Education Questionnaire (DATE-Q) is a self-administered tool developed to evaluate disease-related knowledge and to assess knowledge of five core components of rehabilitation programs: physical exercise, diet, psychosocial well-being, disease self-management, and complications. OBJECTIVE: To translate and cross-culturally adapt into Brazilian Portuguese, and to test the psychometric properties of the DATE-Q for its use in Brazil. METHODS: The process of translation and cross-cultural adaptation consisted of five steps: translation into Brazilian Portuguese, synthesis of translation, back translation, expert committee, and pilot test of pre-final version. The pre-final version was applied to a sample of 30 patients with diabetes. Psychometric properties (internal consistency, reliability, construct validity, and ceiling and floor effects) of the final version of the Brazilian Portuguese version of the DATE-Q were tested in a sample of 200 adults with diabetes. RESULTS: There was no conceptual divergence between the original and the translated versions. Ten (50%) items of the DATE-Q were culturally adapted. Internal consistency (Cronbach's alpha coefficient = 0.6), reliability (intraclass correlation coefficient = 0.5), and construct validity (correlation between Diabetes Knowledge Scales and DATE-Q total scores: ρ = 0.7; P < 0.001) were confirmed. Ceiling or floor effects were not identified. The highest scoring item was about healthy eating. The average time for completion of the DATE-Q was 5 min and 51 s, and the completion rate was 100% for all items. CONCLUSION: The Brazilian Portuguese version of the DATE-Q showed adequate psychometric properties, and results suggested that the tool can be used to assess disease-related knowledge in adults with diabetes in Brazil.

THE INFLAMMATORY BOWEL DISEASE-FATIGUE PATIENT SELF-ASSESSMENT SCALE: TRANSLATION, CROSS-CULTURAL ADAPTATION AND PSYCHOMETRIC PROPERTIES OF THE BRAZILIAN VERSION (IBD-F BRAZIL).

BACKGROUND: Fatigue is a common symptom in patients with inflammatory bowel diseases (IBD). A translated and culturally adapted, instrument with robust psychometric for measuring fatigue in Brazilian patients with IBD is needed. OBJECTIVE: To translate and cross-culturally adapt the inflammatory Bowel Disease Fatigue Scale (IBD-F) into Brazilian-Portuguese and to test its measurement properties in Brazilian patients with IBD. METHODS: Data from 123 patients with IBD were collected. In addition to IBD-F, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) was used. The measurement properties tested were: internal consistency, reproducibility (reliability and agreement), construct validity, internal and external responsiveness, and ceiling and floor effects. RESULTS: The Brazilian-Portuguese version of the IBD-F showed excellent internal consistency (Cronbach's alpha of 0.95), excellent reproducibility (ICC=0.97) and a minimal detectable change of 6.0 points. The construct validity was demonstrated with a good correlation between the IBD-F and FACIT-F (r=- 0.46). Effect sizes used for measuring internal responsiveness were moderate among those with Crohn's (0.66) disease and low in patients with ulcerative colitis (0.24). The Brazilian-Portuguese version of the IBD-F presented with high external responsiveness for Crohn's disease (0.84) and with low external responsiveness for ulcerative colitis (0.33). The area under the curve considered for responsiveness was 0.84. Twenty-five percent of floor effects and no ceiling effect were recorded. CONCLUSION: The Brazilian-Portuguese version of IBD-F has adequate measurement properties and its use can be recommended in clinical practice and research.

Escala de autoavaliação Inflammatory Bowel Disease-Fatigue: tradução, adaptação cultural e propriedades psicométricas da versão Brasileira (IBD-F Brasil) / The inflammatory bowel disease-fatigue patient self-assessment scale: translation, cross-cultural adaptation and psychometric properties of the brazilian version (ibd-f brazil)

ABSTRACT BACKGROUND: Fatigue is a common symptom in patients with inflammatory bowel diseases (IBD). A translated and culturally adapted, instrument with robust psychometric for measuring fatigue in Brazilian patients with IBD is needed. OBJECTIVE: To translate and cross-culturally adapt the inflammatory Bowel Disease Fatigue Scale (IBD-F) into Brazilian-Portuguese and to test its measurement properties in Brazilian patients with IBD. METHODS: Data from 123 patients with IBD were collected. In addition to IBD-F, the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) was used. The measurement properties tested were: internal consistency, reproducibility (reliability and agreement), construct validity, internal and external responsiveness, and ceiling and floor effects. RESULTS: The Brazilian-Portuguese version of the IBD-F showed excellent internal consistency (Cronbach's alpha of 0.95), excellent reproducibility (ICC=0.97) and a minimal detectable change of 6.0 points. The construct validity was demonstrated with a good correlation between the IBD-F and FACIT-F (r=- 0.46). Effect sizes used for measuring internal responsiveness were moderate among those with Crohn's (0.66) disease and low in patients with ulcerative colitis (0.24). The Brazilian-Portuguese version of the IBD-F presented with high external responsiveness for Crohn's disease (0.84) and with low external responsiveness for ulcerative colitis (0.33). The area under the curve considered for responsiveness was 0.84. Twenty-five percent of floor effects and no ceiling effect were recorded. CONCLUSION: The Brazilian-Portuguese version of IBD-F has adequate measurement properties and its use can be recommended in clinical practice and research.

RESUMO CONTEXTO: A fadiga é um sintoma comum em pacientes com doenças inflamatórias intestinais (DII). Um instrumento de avaliação de fadiga traduzido, culturalmente adaptado e com psicometria robusta para medir a fadiga em pacientes brasileiros com DII é necessário. OBJETIVO: Traduzir e adaptar culturalmente a Inflammatory Bowel Disease Fatigue Scale (IBD-F) para o português do Brasil e testar suas propriedades de medida em pacientes brasileiros com DII. MÉTODOS: Foram coletados dados de 123 pacientes com DII. Além do IBD-F, foi utilizada a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). As propriedades de medida testadas foram: consistência interna, reprodutibilidade (confiabilidade e concordância), validade de construto, responsividade interna e externa e efeitos teto e chão. RESULTADOS: A versão em português do IBD-F mostrou excelente consistência interna (alfa de Cronbach de 0,95), excelente reprodutibilidade (ICC=0,97) e uma diferença mínima detectável de 6,0 pontos. A validade do construto foi demonstrada por meio de uma boa correlação entre o IBD-F Brasil e o FACIT-F (r= -0,46). Na análise de responsividade interna, os tamanhos de efeito obtidos foram moderado entre aqueles com doença de Crohn (0,66) e baixo em pacientes com colite ulcerativa (0,24). O IBD-F Brasil apresentou alta responsividade externa entre aqueles com doença de Crohn (0,84) e baixa responsividade externa em pacientes colite ulcerativa (0,33). A área sob a curva considerada para responsividade foi de 0,84. Foram registrados 25% de efeito chão e nenhum efeito teto nas avaliações realizadas. CONCLUSÃO: O IBD-F Brasil possui propriedades de medida adequadas e seu uso pode ser recomendado na prática clínica e na pesquisa em pacientes com DII.