Effects of One Year Perdialytic Physical Activity on Aerobic Capacities and Quality of Life in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Improvement of the distance covered after walking for 6 minutes (6 minutes walk test)
研究概览
简要总结
Patients on chronic hemodialysis present severe physical dysfunctioning associated with a significant reduction of their muscle mass. These two parameters are associated with increased morbidity and mortality along with deconditioning and poor quality of life. There are several studies- usually short term, single center uncontrolled and underpowered- that have shown a significant improvement of the physical, metabolic and dialytic parameters.
There are only few studies that have measured the impact of a long term intradialytic exercise intervention on a supervised manner. This is a multi-center controlled study examining the effects of intradialytic cycling on parameters of physical functioning, body composition, cardiovascular and nutritional status, immunological status and quality of life in a group of clinically stable hemodialysis patients
详细描述
General Context Chronic Kidney Patients (CKD) live a sedentary life. Sedentarity and Sarcopenia worsen during the evolution of CKD with numerous cardiovascular diseases, infectious and other comorbidities. Inactivity may activate and amplify the inflammatory process, hypercoagulability, malnutrition, invoking a vicious circle of further inactivity and deconditioning.
These populations have a very low physical activity profile due to important tiredness, perturbed general condition and bad adaptation in effort. The patients with cardiovascular problems have additional limitations due to breathlessness associated with congestive cardiac failure and intermittent claudication due to peripheral arteriopathy. At the dialysis stages the tiredness is accentuated after the hemodialysis sessions. The days off dialysis are rarely used for practicing a physical activity.
The deconditioning along with the reduction of the physical activity are leading to a de-socializing progressing in the course of the chronic renal failure. In that way the patient feels more and more isolated with a serious eventual impact on the nutrition status and his quality of life.
Regular physical activity in this population of patients is exerting beneficial effects on insulin resistance, inflammation, dialysis efficiency, nutrition and arterial pressure. It may also reduce the intradialytic hypotensive episodes and improve quality of life, without side effects.
The objective of this study is to investigate an improvement of the physical functioning associated with a reprogramming of the autonomous nervous system, a reduction of the pro-inflammatory factors with a reduction of the insulin resistance (reduction of the metabolic syndrome), along with improvements on the immune system functioning for hemodialysis patients participating on a one year intradialytic physical activity program.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting active hemodialysis patients since at least 6 months aged between 20 and 90 y.o.
排除标准
- •Unstable angina,
- •severe left ventricular dysfunction,
- •Ejection fraction < 30%,
- •severe peripheral arterial disease,
- •lower extremity amputation,
- •impossibility of physical effort: pain, uncontrolled bone/muscular disease,
- •participation on another study.
结局指标
主要结局
Improvement of the distance covered after walking for 6 minutes (6 minutes walk test)
时间窗: 12 months
The principal aim of the present study is to show the efficacy of intradialytic physical activity on the improvement of the physical capacity of the patients assessed with the 6 minutes walk test ((6MWT)
次要结局
- Quality of life parameters 3(12 months)
- Physical activity levels(12 months)
- Body composition(12 months)
- Immune parametres(12 months)
- inflammatory parameters 2(12 months)
- inflammatory parameters 6(12 months)
- Improvement of Sit to Stand test in 60 seconds (STS60)(12 months)
- Nutritional and metabolic parameters 1(12 months)
- Nutritional and metabolic parameters 2(12 months)
- Nutritional and metabolic parameters 5(12 months)
- Nutritional and metabolic parameters 6(12 months)
- Dialysis parameters(12 months)
- Quality of life parameters 1(12 months)
- Quality of life parameters 2(12 months)
- Nutritional and metabolic parameters 4(12 months)
- Anemia control 1(12 months)
- Anemia control 3(12 months)
- Cardiovascular parameters(12 months)
- Nutritional and metabolic parameters 3(12 months)
- inflammatory parameters 1(12 months)
- inflammatory parameters 3(12 months)
- inflammatory parameters 4(12 months)
- inflammatory parameters 5(12 months)
- Anemia control 2(12 months)
- Anemia control 4(12 months)
- Duration of hospitalisations(12 months)
- Survival(12 months)
- Number of hospitalisations(12 months)
- Improvement of the time needed to perform 5 Sit to Stand cycles (STS5)(12 months)