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Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study).

ABSTRACT: The effects of exercise training on Chagas heart disease are still unclear. This study aimed to evaluate the effect of exercise training over functional capacity, cardiac function, quality of life, and biomarkers in Chagas heart disease.The PEACH study is a superiority randomized clinical trial which will include subjects who meet the following criteria: Chagas heart disease with a left ventricular ejection fraction below 45 % with or without heart failure symptoms; clinical stability in the last 3 months; adherence to clinical treatment; and age above 18 years. The exclusion criteria are: pregnancy; neuromuscular limitations; smoking; evidence of non-chagasic heart disease; systemic conditions that limit exercise practice or cardiopulmonary exercise test; unavailability to attend the center three times a week during the intervention period; and practitioners of regular exercise. The intervention group will perform an exercise training intervention three times per week during 6 months and will be compared to the control group without exercise. Both groups will undergo the same monthly pharmaceutical and nutritional counseling as well as standard medical treatment according to the Brazilian consensus on Chagas disease. The primary outcome is functional capacity based on peak exercise oxygen consumption during cardiopulmonary exercise testing. Secondary outcomes are: cardiac function; body composition; muscle respiratory strength; microvascular reactivity; cardiac rhythm abnormalities; autonomic function; biochemical; oxidative stress and inflammatory biomarkers; and quality of life. Subjects will be evaluated at baseline, and at 3 and 6 months after randomization. Thirty patients will be randomly assigned into exercise or control groups at a ratio of 1:1.Findings of the present study will be useful to determine if physical exercise programs should be included as an important additional therapy in the treatment of patients with Chagas heart disease.ClinicalTrials.gov ID: NCT02517632 (registered on 6 August 2015).

SUBMITTER: Mendes Fde S

PROVIDER: S-EPMC5010675 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study).

Mendes Fernanda de Souza Nogueira Sardinha Fde S Sousa Andréa Silvestre AS Souza Fernando Cesar de Castro Cesar FC Pinto Vivian Liane Mattos VL Silva Paula Simplicio PS Saraiva Roberto Magalhães RM Xavier Sergio Salles SS Veloso Henrique Horta HH Holanda Marcelo Teixeira MT Costa Andréa Rodrigues AR Carneiro Fernanda Martins FM Silva Gilberto Marcelo Sperandio GM Borges Juliana Pereira JP Tibirica Eduardo E Pinheiro Roberta Olmo RO Lara Flávio Alves FA Hasslocher-Moreno Alejandro Marcel AM Brasil Pedro Emmanuel Alvarenga Americano PE Mediano Mauro Felippe Felix MF

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<h4>Background</h4>The effects of exercise training on Chagas heart disease are still unclear. This study aimed to evaluate the effect of exercise training over functional capacity, cardiac function, quality of life, and biomarkers in Chagas heart disease.<h4>Methods</h4>The PEACH study is a superiority randomized clinical trial which will include subjects who meet the following criteria: Chagas heart disease with a left ventricular ejection fraction below 45 % with or without heart failure symp ...[more]

PMID: 27590681

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Project description:Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery.The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient's home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed at baseline and post-intervention. In addition, adherence and safety are monitored throughout the exercise program.This randomized controlled trial investigates effects of physical exercise versus usual care in esophageal cancer patients after surgery. As the design of the exercise program closely resembles daily practice, this study can contribute both to evidence on effects of exercise in esophageal cancer patients, and to potential implementation strategies.Trial registration:Netherlands Trial Registry NTR5045 Date of trial registration: January 19th, 2015 Date and version study protocol: February 2017, version 1.

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Project description:BackgroundBenefits from cardiac rehabilitation (CR) programs are evidence-based and widely recognized. Less than 50% of people who participate in hospital-based CR programs maintain an exercise regime for as long as six months after completion. Little is known about interventions making the patients continue to exercise after the hospital-based formal program has ended. Methods to ensure sustained benefits of CR need to be tackled. Exercise periodization is a method typically used in sports training, but the impact of periodized exercise to yield optimal beneficial effects in cardiac patients is unclear. Therefore, the purpose of this trial is to evaluate the effects of a long-term exercise periodization on health-related physical fitness components such as cardiorespiratory endurance, muscular strength, skeletal muscle function, and body composition.MethodsFifty patients with coronary artery disease will be recruited among those who underwent the hospital-based CR phase. These patients will be randomized (1:1) into one of the following exercise groups: (1) periodized group; and (2) non-periodized group (exercise prescription based on standard guidelines). There will be four assessment time points: at baseline, and 3, 6, and 12 months after starting the exercise training program. At each time point, maximal and submaximal cardiorespiratory fitness, skeletal muscle deoxygenation dynamics, body composition by dual energy radiographic absorptiometry, functional fitness, maximal isometric and dynamic strength, physical activity, and quality of life will be assessed. This experimental design will last for 48 weeks with a frequency of three times per week for both groups.DiscussionMost medium- to long-term exercise-based CR programs do not employ periodization or exercise progression. Randomized controlled trials are necessary to evaluate long-term periodization outcomes and assess the length of change observed in supervised CR programs. This study will contribute to generate evidence-based exercise prescription approaches to prolong the exercise training after the end of hospital-based CR programs.Trial registrationClinicalTrials.gov, NCT03335319 . Registered on 22 October 2017.

Project description:Regular physical activity (PA) is an important part of the treatment of several medical conditions, including overweight and obesity, in which there may be a weakened appetite control. Eating behaviour traits influence weight control and may be different in active and sedentary subjects. This paper reports the relationships between the time spent in sedentary behaviour and physical activity (PA) of different intensity, and eating behaviour traits in young, healthy adults. Additionally, it reports the results of a six-month-long, randomized, controlled trial to examine the effect of an exercise intervention on eating behaviour traits. A total of 139 young (22.06 ± 2.26 years) healthy adults (68.35% women) with a Body Mass Index (BMI) of 24.95 ± 4.57 kg/m2 were enrolled. Baseline assessments of habitual PA were made using wrist-worn triaxial accelerometers; eating behaviour traits were examined via the self-reported questionnaires: Binge Eating, Three-Factor Eating Questionnaire-R18 and Control of Eating Questionnaire. The subjects were then randomly assigned to one of three groups: control (usual lifestyle), moderate-intensity exercise (aerobic and resistance training 3¨C4 days/week at a heart rate equivalent to 60% of the heart rate reserve (HRres) for the aerobic component, and at 50% of the 1 repetition maximum (RM) for the resistance component), or vigorous-intensity exercise (the same training but at 80% HRres for half of the aerobic training, and 70% RM for the resistance training). At baseline, sedentary behaviour was inversely associated with binge eating (r = -0.181, p < 0.05) and with uncontrolled eating (r = -0.286, p = 0.001). Moderate PA (MPA) was inversely associated with craving control (r = -0.188, p < 0.05). Moderate-to-vigorous PA (MVPA) was directly associated with binge eating (r = 0.302, p < 0.001) and uncontrolled eating (r = 0.346, p < 0.001), and inversely associated with craving control (r = -0.170, p < 0.015). Overall, PA was directly associated with binge eating (r = 0.275, p = 0.001), uncontrolled eating (r = 0.321, p < 0.001) and emotional eating (r = 0.204, p < 0.05). Additionally, only emotional eating was modified by the intervention, increasing in the vigorous-intensity exercise group (p < 0.05). In summary, we observed that time spent in sedentary behaviour/PA of different intensity is associated with eating behaviour traits, especially binge eating in young adults. In contrast, the six-month exercise intervention did not lead to appreciable changes in eating behaviour traits.

Dataset Information

Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study).

Publications

Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study).

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