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

Autor: Silva LPD; Faculty of Physical Therapy, Federal University of Juiz de Fora, Juiz de Fora, Brazil. lilian.pinto@ufjf.br.; Graduate Program in Physical Education, Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, Brazil. lilian.pinto@ufjf.br., Batalha APDB; Graduate Program in Physical Education, Faculty of Physical Education and Sports, Federal University of Juiz de Fora, Juiz de Fora, Brazil., Ghisi GLM; KITE Research Institute, University Health Network, University of Toronto, Toronto, Canada., Seixas MB; Faculty of Physical Therapy, Federal University of Juiz de Fora, Juiz de Fora, Brazil., Cisneros LL; Department of Physical Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil., Jansen AK; Department of Nutrition, Federal University of Minas Gerais, Belo Horizonte, Brazil., Moreira APB; Department of Nutrition, Federal University of Juiz de Fora, Juiz de Fora, Brazil., Pereira DS; Department of Physical Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil., Britto RR; Department of Physical Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil., Pereira DAG; Department of Physical Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil., Trevizan PF; Department of Physical Therapy, Federal University of Minas Gerais, Belo Horizonte, Brazil., Oh P; KITE Research Institute, University Health Network, University of Toronto, Toronto, Canada.; Cardiovascular Rehabilitation and Prevention Program, Toronto Rehabilitation Institute, University Health Network, Toronto, Canada.
Jazyk: angličtina
Zdroj: Trials [Trials] 2024 Oct 21; Vol. 25 (1), pp. 701. Date of Electronic Publication: 2024 Oct 21.
DOI: 10.1186/s13063-024-08535-6
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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