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Clinical Trials/NCT03511924
NCT03511924CompletedNot Applicable

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

Pavol Jozef Safarik University2 sites in 1 country90 target enrollmentStarted: January 11, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
2
Primary Endpoint
Change in lower extremity muscle strength

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Change in lower extremity muscle strength

Time Frame: 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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Pavol Jozef Safarik University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jaroslav Rosenberger

Jaroslav Resenberger, MD, PhD.

Pavol Jozef Safarik University

Study Sites (2)

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