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临床试验/NCT03511924
NCT03511924已完成不适用

Effect of Intradialytic Resistance Training on Circulatory miRNA Profile and Muscle Strength in Haemodialysis Patients

Pavol Jozef Safarik University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Change in lower extremity muscle strength

研究概览

简要总结

The study will investigate the effects of an intradialytic resistance training on miRNA´s expression and muscle strength in haemodialysis patients.

详细描述

Chronic kidney disease (CKD) is accompanied by distortions of immune functions and acceleration of inflammation processes. Regular exercise has shown great potential for improving the health-related parameters of CKD patients. Moreover, muscle strength is considered to be an important predictor of protein- and energy- wasting, inflammation, quality of life and mortality in CKD patients. The behaviour and individual variability of adaptation to regular, controlled, supervised physical activities in CKD patients are not well defined and understood. The understanding of molecular adaptation mechanisms, represented by the epigenetic impact of exercise on renal specific miRNA´s expression, is necessary for future improvements in clinical practice. Monitoring pro- and anti-inflammation genes activity, their transcription factors and expression of miRNA molecules (influencing the signalling pathways of specific genes) will enable us to draft a new transcription and translation model for exercise-induced adaptation in CKD patients. Additionally, our results will indicate the clinical value of selected markers for the diagnostics and prognostics of disease.

研究设计

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

入排标准

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

入选标准

  • All patients over 30 years of age, diagnosed with chronic kidney disease, treated with haemodialysis are eligible for our study.

排除标准

  • Lower extremity amputation, severe dementia or retardation, acute intercurrent disease and probability of one year mortality higher than 25 % according to Charlson Comorbidity Index (CCI) are the exclusion criteria for participation in the study.

结局指标

主要结局

Change in lower extremity muscle strength

时间窗: Before the intervention, 1-5 days after the completion of the 12-week intervention and after 3 months follow up

Change in maximal voluntary force produced during knee extension, leg flexion, extension and hip abduction, adduction will be assessed by dynamometer

次要结局

  • Change in activity of circulatory miRNA molecules involved in TRIM63 and IGF-1 signalling pathways(Before the intervention and 1-5 days after the completion of 12-week intervention)
  • Change in renal specific clinical data(Before the intervention, 1-5 days after the completion of the 12-week intervention and after 3 months follow up)
  • Change in score on the Hospital Anxiety and Depression Scale(Before the intervention and 1-5 days after the completion of 12-week intervention)
  • Change in score on the Kidney Disease Quality of Life(Before the intervention and 1-5 days after the completion of 12-week intervention)

研究者

发起方
Pavol Jozef Safarik University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaroslav Rosenberger

Jaroslav Resenberger, MD, PhD.

Pavol Jozef Safarik University

研究点 (2)

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