DiaSport - Ausdauerorientiertes Trainingsprogramm Mit Kindern Und Jugendlichen an Der Dialyse (DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change of single pool Kt/V (KDOQI Guidelines) - expressed as the change of single pool Kt/V from week 0 to 12 of intervention (period 1)
研究概览
简要总结
Physical activity is considered essential for optimal health, development, socialization and well-being of children. However patients with end-stage renal disease (ESRD) are often restricted from participation in exercise activities. This is especially true for children on hemodialysis (HD). As a consequence their exercise capacity is reduced, both before, but most impressively after HD. In a nationwide randomized, multi-center design this study aims to proof the influence of an individualised endurance training program by bicycle ergometer performed during dialysis on the efficacy of HD, measured as single pool Kt/V. Secondary goals are to enhance physical performance, physical and mental well-being, and to improve measurable blood and treatment parameters (e.g. haemoglobin level, amount of medication). A positive impact of physical activity was observed in adults on HD, although most studies did not address this issue in a randomised protocol. Despite this beneficial evidence in adults, sport is still not integrated as part of standard care in patients on maintenance HD. The study protocol, developed in close collaboration with the German Sport University Cologne, differs substantially from previously published reports as it uses bicycle ergometer training in an upright position outside the dialysis couch and adapts the intensity of intervention to the patient's capabilities. Based on the expected results the investigators will develop an individualised training program to be integrated in the standard care of (pediatric) patients on maintenance HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage renal disease with need of renal replacement therapy
- •children and adolescents aged ≥6 to ≤19 years
- •maintenance hemodialysis for at least 3 months
- •Stable and appropriate dialysis condition in the last 4 weeks before inclusion to the study (basically stable blood and dialysate flow rate and same dialyser)
- •single pool Kt/V according to Dialysestandard 2006 > 1.2
- •Informed consent
排除标准
- •Participation in another interventional clinical trial
- •severe primary neurologic, orthopaedic or cardiac disease, or secondary disease known as a contraindication for endurance training
- •uncontrolled hyper- or hypotension, or cardiac disease
- •Recurrent uncontrolled epileptic seizures
- •dialysis shunt at the lower limbs
- •pregnancy
- •already planned medical intervention, for example living donor kidney transplantation or any other surgery, within the first period of the trial which will cause cancelation of more then 3 training units in a row
- •Subjects who are in dependency to the sponsor or the PI of the trial, or confined to an institution on judicial or official behalf
研究组 & 干预措施
Bicycle-Ergometer Training Group
Performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes, with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions).
In the second part of the study intervention will be prolonged for another 12 weeks.
干预措施: Bicycle-Ergometer Training (Other)
Control
No intervention during hemodialysis during the first 12 weeks of the study.
In the second part of the study a training program, according to that of the intervention group, will be performed with a performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes, with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions).
干预措施: Bicycle-Ergometer Training (Other)
结局指标
主要结局
Change of single pool Kt/V (KDOQI Guidelines) - expressed as the change of single pool Kt/V from week 0 to 12 of intervention (period 1)
时间窗: 12 weeks
Change of single pool Kt/V (spKt/V) measured at week 12 (V1) compared to baseline (V0). Single pool Kt/V is the standard measure to assess dialysis efficacy. As dialysis efficacy is the primary aim of dialysis treatment and the spKt/V is the best way to measure efficacy this figure has an important clinical relevance for the patient.
次要结局
- Body Composition Monitoring (BCM)(12 and 24 weeks)
- Quality of Life(12 and 24 weeks)
- Change of solute removal during hemodialysis(12 and 24 weeks)
- Telomere length and Telomerase activity(12 and 24 weeks)
- Change of the possible workload (maximum physical performance) achieved(12 and 24 weeks)
- Inflammation, nutritional status and bone metabolism(12 and 24 weeks)
- Change of number and dose of medication needed(12 and 24 weeks)
- Change of solute removal in the two compartment model (assessed in a subgroup of patients)(12 and 24 weeks)
研究者
Prof. Dr. B. Hoppe
Prof. Dr. med.
University of Bonn