Intradialytic Resistance Training in Haemodialysis Patients

NCT ID: NCT03511924

Last Updated: 2020-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-11

Study Completion Date

2020-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intradialytic resistance training

During the 12-week intradialytic training plan subjects will be performed 3 to 5 sets of 3 different lower extremities exercises, each set will consist of 12 up to 18 repetitions of a single exercise. Subjects will take 1 to 2 minutes rest between each set. The resistance training will be realized 3 times per week and will be performed during haemodialysis therapy.

Group Type EXPERIMENTAL

Intradialytic resistance training

Intervention Type BEHAVIORAL

Progressive resistance training programme performed during haemodialysis, taking into account subject´s medical review summarizing: A. full medical history, B. clinical examination including cardiovascular assessment, C. detailed medication usage history, D. review of recent biochemistry and haematology records and results of lower extremity muscle strength assessments. Construction of intradialytic training programme followed recommendations published by the Exercise \& Sports Science Australia (Smart et al., 2013).

Control programme

Control subjects will receive no intervention during the 12-weeks of the experiment. Through the 12-week control period, all participants will be instructed to maintain a standard treatment regimen and to maintain their customary dietary and physical activity patterns.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intradialytic resistance training

Progressive resistance training programme performed during haemodialysis, taking into account subject´s medical review summarizing: A. full medical history, B. clinical examination including cardiovascular assessment, C. detailed medication usage history, D. review of recent biochemistry and haematology records and results of lower extremity muscle strength assessments. Construction of intradialytic training programme followed recommendations published by the Exercise \& Sports Science Australia (Smart et al., 2013).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dialysis Services Fresenius Medical Care Slovakia

UNKNOWN

Sponsor Role collaborator

Private Health Institution Logman - Logman East

UNKNOWN

Sponsor Role collaborator

Pavol Jozef Safarik University

OTHER

Sponsor Role lead

Responsible Party

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Jaroslav Rosenberger

Jaroslav Resenberger, MD, PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fresenius Medical Care - Dialysis Services Košice, Slovakia

Košice, , Slovakia

Site Status

Countries

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Slovakia

References

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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.

Reference Type BACKGROUND
PMID: 23434075 (View on PubMed)

Zelko A, Rosenberger J, Kolarcik P, Madarasova Geckova A, van Dijk JP, Reijneveld SA. Age and sex differences in the effectiveness of intradialytic resistance training on muscle function. Sci Rep. 2023 Mar 1;13(1):3491. doi: 10.1038/s41598-023-30621-z.

Reference Type DERIVED
PMID: 36859437 (View on PubMed)

Other Identifiers

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PJSU-JR

Identifier Type: -

Identifier Source: org_study_id

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