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临床试验/NCT02155036
NCT02155036已完成1 期

The Effect of Exercise on Renal Function and Cardiovascular Disease in Pre-dialysis (Chronic Kidney Disease Stage 3-4) Patients With Chronic Kidney Disease; a Randomised Controlled Trial Pilot Study.

King's College Hospital NHS Trust2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
kidney function

研究概览

简要总结

The proposed research aims to examine whether regular aerobic exercise can preserve renal function, improve aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life. Ultimately, the research aims to prove that exercise is a more cost-effective and a more efficient use or healthcare resources used in the treatment of patients with CKD. Exercise is a relatively cheap treatment option which is readily available and accessible for this patient population. establish if, compared with usual care, an exercise programme for pre-dialysis CKD patients;

  1. Preserves renal function.
  2. Improves aerobic capacity, physical and psychosocial function, strength, cardiovascular function, general well-being and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Stages 3-4 chronic kidney disease (CKD) patients (glomerular filtration rate (GFR) 20-60 mL/min)
  • Male or female
  • Aged >18 years
  • Written informed consent

排除标准

  • Pregnancy
  • Requiring support for ambulation less than 20m
  • Vasculitis,
  • Proliferative diabetic retinopathy,
  • Severe osteodystrophy,
  • Uncontrolled diabetes,
  • Psychiatric illness, including anxiety, mood and untreated eating disorders
  • Infection or course of antibiotics within the last month

结局指标

主要结局

kidney function

时间窗: up to 12 months

estimated glomerular filtration rate (egfr) creatinine

次要结局

  • Body mass index (BMI)(Baseline, 6 and 12 months)
  • Cardio-respiratory fitness testing (VO2peak)(Baseline, 6 and 12 months)
  • Waist circumference(Baseline, 6 and 12 months)
  • Duke's activity status index(Baseline, 6 and 12 months)
  • Short Form 36 questionnaire(Baseline, 6 and 12 months)
  • Total cholesterol(Baseline, 6 and 12 months)
  • High sensitivity c-reactive protein (Hs CRP)(Baseline, 6 and 12 months)
  • Blood pressure(Baseline, 6 and 12 months)
  • Resting heart rate (HR)(Baseline, 6 and 12 months)
  • Triglycerides(baseline, 6 and 12 months)
  • Pulse Wave Velocity (arterial stiffness)(Baseline, 6 and 12 months)
  • weight(Baseline, 6 and 12 months)

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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