Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study (EXRED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in Glomerular filtration rate (GFR) and urine abulmin-creatinine ratio (UACR).
研究概览
简要总结
INTRODUCTION: Obesity (OB) and metabolic syndrome (MetS) are risk and progression factors for chronic kidney disease (CKD). However, the effect of OB/MetS intervention with exercise on renal function progression and proteinuria is unknown.
OBJECTIVE: To analyse the effect of therapeutic exercise on MetS and main renal outcomes in patients with CKD.
METHODOLOGY: This is a 6-month prospective exploratory study. Patients with stablished CKD (1-4) and MetS were treated with individualised incremental exercise (aerobic and resistance). Simultaneously, a plan of adherence was set up to promote compliance. Renal and metabolic outcomes were collected. The main renal parameters were: proteinuria, in isolated urine samples, and glomerular filtration rate (GFR), measured by iohexol DBS, at 0, 3 and 6 months. At the same time points, metabolic outcomes were measured: weight, dyslipidemia, insulin resistance and hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years
- •CKD of diverse aetiologies
- •estimated GFR ≥ 30 ml/min
- •BMI ≥ 27 kg/m2 associated to MetS or diabetes mellitus (DM)
- •stable renal function for at least 6 months before screening
- •ability to perform exercise
排除标准
- •clinical conditions that exclude exercise therapy such as clinical instability, active infection, cancer, acute cardiovascular disease, advanced CKD, pulmonary hypertension, or limb amputations
- •inability to understand the protocol
- •severe psychiatric illness
- •allergy to iodine
结局指标
主要结局
Changes in Glomerular filtration rate (GFR) and urine abulmin-creatinine ratio (UACR).
时间窗: Baseline, 3 and 6 months
GFR and UACR were measured at baseline, 3 and 6 months, with the gold standard method of plasma clearance of iohexol (DBS technique) and urine analysis (isolated urine samples), respectively. The researchers expect a change in terms of GFR (improvement of hyperfiltration) and UACR reduction compared to baseline.
次要结局
- Changes in body weight and MetS traits (Analytics).(Baseline, month 3 and 6.)
- Compliance-adherence(Monthly)
研究者
Raúl Morales Febles
PhD-Physiotherapist
University of La Laguna