SEDentary Lifestyle, Mortality and Major Adverse Clinical Outcomes in Chronic KIDney Disease. A Prospective Multicenter Follow-up Protocol With a Nested Randomized Controlled Trial of Physical Education Benefits - The SEDKID Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Hospitalisations
研究概览
简要总结
The goal of this study is to learn if a simple home exercise program can benefit patients with advanced chronic kidney disease. There is also an observational part of the study without an exercise program.
The study will record patients' mortality, cardiovascular events, emergency department visits, hospital stays, need for dialysis and 6 minutes walking distance. Also maximal oxygen uptake, quality of life and bone fractures are recorded and blood tests and X-rays analyzed. The prospective observational part of the study will investigate the link between cardiovascular and kidney health as well as exercise capacity and adverse outcomes.
详细描述
The prevalence of chronic kidney disease (CKD) and patients on maintenance dialysis is increasing, and affected patients are at elevated risk of premature death and adverse cardiovascular events.
Frailty is a term used to describe aging related attenuation of physical, mental, psychological and cognitive performance. Frailty is common in patients with CKD. Frailty is associated with increased mortality, hospitalization and falls in both the general population and in CKD.
Treatment of frailty is challenging due to its multidimensional nature and the old age and comorbidity of the affected patients. In spite these challenges, physical rehabilitation and training programs have been shown to successfully improve the prognosis of patients with CKD.
The investigators hypothesize that marked frailty is associated with a weak prognosis in spite renal replacement therapy and kidney transplantation. Because advanced predialysis stage CKD carries a high risk of adverse events and kidney transplants available are scarce, it is imperative to identify those elderly CKD stage 5 patients that benefit from initiating renal replacement therapy and those who are unlikely to benefit to avoid futile intensive treatment when it does not improve prognosis or quality of life. The investigators expect that the progression of frailty may up to a point be hindered using a simple physical exercise program that can be produced cost effectively to aid a large number of patients.
The trial aims to examine the benefits of an individual physical training education program in advanced CKD. In addition to the controlled trial setting the study examines the association between measures of frailty, physical and psychological capability assessed at study inclusion (baseline) and incident hospitalization, mortality, renal replacement therapy (RRT) and major adverse cardiovascular events during follow-up.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >40 years
- •Estimated glomerular filtration rate < 20ml/min/1.73m2 (CKD stage 4-5)
- •Informed consent from the patient is received
排除标准
- •Maintenance dialysis dependency before inclusion
- •Pregnant women
- •Patient's lack of commitment to follow-up
- •Chronic or acute clinical condition with a prognosis less than 6 months
- •Amputated lower limbs
研究组 & 干预措施
Exercise Program
干预措施: EXERCISE TRAINING WITH OR WITHOUT MEDICATION (Behavioral)
Standard of Care
结局指标
主要结局
Hospitalisations
时间窗: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Mortality
时间窗: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Major Adverse Cardiovascular or Cerebrovascular Event (MACCE)
时间窗: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Emergency Department Visits
时间窗: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
6-minute Walking Test Distance
时间窗: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Compliance to the home training program
时间窗: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Compliance of the intervention group assessed at every clinical control visit and tri-monthly by telephone.
Renal Replacement Therapy
时间窗: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
start of dialysis or kidney transplantation
次要结局
- Change in Quality of life(1 year, 2 years, 3 years, 5 years, 31 Dec 2031)
- Maximal oxygen uptake in the exercise stress test(1 year, 2 years, 3 years, 5 years, 31 Dec 2031)
- Bone fractures(1 year, 2 years, 3 years, 5 years, 31 Dec 2031)
