Clinical trial NCT03511924: Intradialytic Resistance Training in Haemodialysis Patients
Official title: Effect of Intradialytic Resistance Training on Circulatory miRNA Profile and Muscle Strength in Haemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: resistance training
circulating miRNA
muscle strength
Lead sponsor: Pavol Jozef Safarik University
Sponsor class: OTHER
Collaborators: name: Dialysis Services Fresenius Medical Care Slovakia
name: Private Health Institution Logman - Logman East
First posted: 2018-04-30
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in lower extremity muscle strength
timeFrame: Before the intervention, 1-5 days after the completion of the 12-week intervention and after 3 months follow up
Secondary outcomes:
measure: Change in activity of circulatory miRNA molecules involved in TRIM63 and IGF-1 signalling pathways
timeFrame: Before the intervention and 1-5 days after the completion of 12-week intervention
measure: Change in renal specific clinical data
timeFrame: Before the intervention, 1-5 days after the completion of the 12-week intervention and after 3 months follow up
measure: Change in score on the Hospital Anxiety and Depression Scale
timeFrame: Before the intervention and 1-5 days after the completion of 12-week intervention
measure: Change in score on the Kidney Disease Quality of Life
timeFrame: Before the intervention and 1-5 days after the completion of 12-week intervention
Other outcomes:
measure: Satisfaction with Life Scale
timeFrame: 1-5 days before the intervention
measure: Multidimensional Scale of Perceived Social Support
timeFrame: 1-5 days before the intervention
measure: Health literacy
timeFrame: 1-5 days before the intervention
measure: Karnofsky Performance Status
timeFrame: 1-5 days before the intervention
measure: Subjective Global Assessment
timeFrame: 1-5 days before the intervention
Locations:
city: Košice
country: Slovakia
facility: Fresenius Medical Care - Dialysis Services Košice, Slovakia
Study officials:
References:
citation: Smart NA, Williams AD, Levinger I, Selig S, Howden E, Coombes JS, Fassett RG. Exercise & Sports Science Australia (ESSA) position statement on exercise and chronic kidney disease. J Sci Med Sport. 2013 Sep;16(5):406-11. doi: 10.1016/j.jsams.2013.01.005. Epub 2013 Feb 21.