Exercise During Hemodialysis: The Dialysis Training Therapy (DiaTT) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,211
- 试验地点
- 22
- 主要终点
- Sit-to-stand test (STS60)
研究概览
简要总结
DiaTT is an interventional, cluster-randomized (1:1), multicenter trial for patients with chronic kidney disease undergoing hemodialysis (n=1,100). This trial will test the effectiveness (by change of sit-to-stand test between baseline and 12 months) of intradialytic exercise training (ET) and health literacy counseling (HLC) for 12 months (Intervention group) in comparison to control group (usual care, UC; no ET, no HLC).
详细描述
The primary objective of this trial is to assess the effectiveness of intradialytic exercise training (ET) and health literacy counselling (HLC) over 12 months intervention in patients undergoing chronic outpatient hemodialysis as compared to usual care (UC). The primary endpoint is change in Sit-to-Stand (STS60) test, from baseline to after 12 months intervention. The ET consists of both resistance and endurance training, focusing on improving patients' health status and physical functioning. Health literacy counseling aims at improving education, proficiency and self-awareness of the patient.
All patients undergoing hemodialysis in participating centers (clusters) for at least four weeks are eligible to participate in the study. Irrespective of randomized center (cluster) group assignment, all dialysis and overall medical treatments will remain unchanged and follow standard of care and center routine without adaptations to the training intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age
- •chronic ambulatory hemodialysis for > 4 weeks
- •Written and signed confirmation by the treating dialysis physician that the patient is able to exercise
- •signed informed consent to participation in QiN registry
- •signed informed consent obtained according to confidentiality and data protection regulation, international guidelines and local laws
排除标准
- •Unstable angina pectoris
- •Uncontrolled arterial hypertension (systolic blood pressure > 180 mmHg or diastolic BP > 105 mmHg on repeated measurements)
- •Uncontrolled tachycardia
- •Acute severe infection
- •Planned live kidney transplantation within the next 12 months
- •Planned conversion to home-hemodialysis or peritoneal dialysis within the next 12 months
- •Dialyzing in long overnight dialysis shift
- •Participation in a regular exercise program during hemodialysis sessions (≥ 1/week) in the last 6 months
结局指标
主要结局
Sit-to-stand test (STS60)
时间窗: between baseline and 12 months
Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds)
次要结局
- health economics by hospitalization(12 months)
- sudden death(12 months)
- Timed-up-and-go test (TUG)(3, 6, 9, and 12 months)
- Six-Minutes-Walk test (6MWT)(3, 6, 9, and 12 months)
- Grip strength test (GST)(3, 6, 9, and 12 months)
- hospitalizations(12 months)
- Serum phosphate(3, 6, 9 and 12 months)
- Overall survival(12 months)
- health economics by transportation(12 months)
- frailty by Multidimensional Prognostic Index (MPI)(3,6 and 12 months)
- Quality of life by SF-36(3, 6 and 12 months)
- Health literacy by HLS-EU-Q16(3, 6 and 12 months)
- health economics by medication(12 months)
- health economics by medical assistance tools(12 months)
- health economics by nursing(12 months)
- needle dislocation/ catheter disconnection(12 months)
- symptomatic hypotensive episodes(12 months)
- 3-point MACE(12 months)
- Sit-to-stand test (STS60)(3, 6 and 9 months)
- Erythropoietin dose(3, 6, 9, and 12 months)
- cramps(12 months)
- health economics by sick leave from workplace(12 months)
研究者
Prof. Dr. med. Martin Halle
Univ.-Prof. MD
Technical University of Munich