Effects of a Program of Aerobic Exercise on the Profile of Intestinal Microbiota and Cardiovascular Markers in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Uremic toxins
研究概览
简要总结
Patients with chronic kidney disease (CKD), especially those who are on dialysis, have a high prevalence of cardiovascular mortality and among the risk factors; inflammation and oxidative stress stand out. Furthermore, recently this scenario, beyond those alterations found in these patients, it has been suggested that the imbalance gut microbiota might be a new factor of cardiovascular risk. Some treatment strategies have been studied in order to modulate the gut microbiota and inflammation, such as the implementation of exercise programs. However, the effects of exercise on the modulation of the gut microflora and inflammation have not been evaluated in these patients. The aim of this project is to investigate possible changes in gut microbiota, levels of uremic toxins and inflammatory and cardiovascular markers in CKD patients on hemodialysis, after application of a training program with aerobic exercise.
详细描述
Chronic kidney disease (CKD) patients on hemodialysis (HD) patients present reduced functional capacity to approximately 50% and uremic myopathy and disuse atrophy have a significant impact on the functional capacity of these patients (Johansen, 1999; Parsons, 2006).
There are several physical exercise benefits for CKD patients, such as improved ability to perform exercises, increase of strength, quality of life and improve the maximal oxygen consumption (VO2MÁX), which contributes to the improvement of cardiovascular aspects (Johansen, 2007; Johansen, 2005; Heiwe, 2014). In fact, CKD patients who practice regular exercise have a higher survival rate (O'Hare et al., 2003).
In addition, some mechanisms regarding anti-inflammatory effects of the exercises has been proposed, such as: reduction of visceral fat which decreases the secretion of pro-inflammatory cytokines, increased production and release of anti-inflammatory cytokines from muscle contraction and reduced expression of Toll-like receptors (TLRs) in monocytes and macrophages, which decreases the pro-inflammatory response (Petersen & Pedersen, 2005; Gleeson et al., 2006).
In parallel, during exercises like running or cycling, there is an increase in capillary surface area, with opening of capillaries previously inactive, consequently increasing exchange of substances between the blood and the tissues. Thus, physical exercise could result in a greater flux of urea and associated toxins from tissue to vascular compartment, improving the efficiency of dialysis (Parsons et al., 2006; Guyton E Hall, 2017). According KDOQI (Kidney Disease Outcomes Quality Initiative), Kt/V, a measure of urea clearance, is the most frequently applied measure of the delivered dialysis dose and reflects the dialyzer effect on patient survival (KDOQI, 2015).
Despite results showing the benefits of exercise to CKD patients, they are poorly prescribed, remaining a challenge in clinical practice and high rates of physical inactivity are observed in these patients (Williams et al., 2014; Barcellos, 2018).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sedentary men and women between the ages of 18 and 60;
- •patients with hemodialysis only with vascular access arteriovenous fistula who have been in dialysis for more than 6 months
- •patients with hemoglobin levels greater than 10 mg / dL.
排除标准
- •Patients taking catabolizing drugs, vitamin supplements, antioxidants, probiotics, prebiotics, symbiotics and antibiotics;
- •patients with autoimmune, infectious, cancer, AIDS,
- •patients with clinically unstable diseases (AMI less than 1 year, unstable angina, atrial fibrillation, significant cardiac arrhythmia and acute disease in the last month)
- •patients with frequent hypotension during dialysis
- •patients with chronic obstructive pulmonary disease and glycemic lability;
- •incapacitated to perform exercise (amputation without prosthesis);
- •musculoskeletal pain at rest or with minimal physical activity,
- •inability to sit or walk without assistance,
- •dyspnoea at rest or at slight exertion (NYHA III and IV).
- •impediment to completing the proposed exercise protocol (travel, imminent renal transplantation).
研究组 & 干预措施
Exercise group
Intradialytic aerobic exercise, 3 times a week, for 12 weeks.
干预措施: Aerobic exercise (Other)
Non-exercise group
Without intradialytic aerobic exercise for 12 weeks.
结局指标
主要结局
Uremic toxins
时间窗: 12 weeks
Evaluation of P-Cresyl Sulfate, Indoxyl Sulfate (IS), Indole 3-Acetic Acid, Trimethyl N-oxide (TMAO) and lipopolysaccharides (LPSs).
Inflammatory biomarkers
时间窗: 12 weeks
Get blood samples to evaluate changes in the expression of transcription factors (nuclear factor erythroid 2-related factor 2 and Nuclear Factor-kB) that modulate inflammation.
次要结局
未报告次要终点