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Chronic Kidney Disease Requiring Chronic DialysisIRTHEPNCT03511924

Intradialytic Resistance Training in Haemodialysis Patients

A study testing Intradialytic resistance training in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Pavol Jozef Safarik University at 1 site in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 30 years and older
What is being tested?
Intradialytic resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteSlovakia
Study dates
11 Jan 2018to 31 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Slovakia1 site

  • Fresenius Medical Care - Dialysis Services Košice, Slovakia

    Košice, 04011

Other trials in Slovakia

About this study

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

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

Read the 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.

Being tested
Intradialytic resistance training
Keywords
resistance training, circulating miRNA, muscle strength

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intradialytic resistance trainingBehavioural

    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).

Study groups in NCT03511924
Study groupRoleWhat they receive
Intradialytic resistance trainingExperimentalDuring 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.
Receives: Behavioral: Intradialytic resistance training
Control programmeNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in lower extremity muscle strength

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

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

Secondary outcomes (4)

  1. Change in activity of circulatory miRNA molecules involved in TRIM63 and IGF-1 signalling pathways

    Blood plasma will be collected for miRNAs analysis. We will analyze the activity of miRNAs involved in TRIM63 and IGF-1 signalling pathways for better definitions of chronic renal insufficiency and muscular adaptation following progressive resistance training. For miRNA analysis, we selected circulatory miRNA´s which were previously connected with regulation of calcium metabolism, calcification processes, protein-energy wasting, muscle mass and functions

    Measured: Before the intervention and 1-5 days after the completion of 12-week intervention

  2. Change in renal specific clinical data

    Clinical data will be collected from the medical documentation of patients. The extracted database will contain patient´s nephrological diagnosis profile, data about the presence of other diagnosis and comorbidities, body composition parameters and standard dialysis biochemistry, haematology and dialysis adequacy measures.

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

  3. Change in score on the Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale (HADS) will be used to assess states of depression and anxiety in the setting of a hospital medical outpatient clinic. The HADS consists of two subscales, subscale for anxiety and subscale for depression. Both subscales contains seven items and each item is rated on a four-point scale (numeric score range from 0 to 3 points). Maximal score for both subscales is 21, minimal score is 0. Scores of 11 or more on either subscale are considered to be a significant indicator of psychological morbidity. Scores between 8 and 10 represents "borderline" and scores between 0 and 7 represents "normal" indication of anxiety and depression.

    Measured: Before the intervention and 1-5 days after the completion of 12-week intervention

  4. Change in score on the Kidney Disease Quality of Life

    Kidney Disease Quality of Life (KDQOL™) instrument will be used to assess generic and kidney-disease targeted aspects of quality of life (self-rated health, self-rated change of health status, physical and mental component) of patients on haemodialysis.

    Measured: Before the intervention and 1-5 days after the completion of 12-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2018
  2. Study start11 Jan 2018
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03511924
Sponsor's protocol ID
PJSU-JR
Acronym
IRTHEP
Status last verified
Mar 2020
First submitted
13 Apr 2018
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23434075

  • 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.

    PubMed 36859437

Questions about this trial

What is this clinical trial studying?

A study testing Intradialytic resistance training in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by Pavol Jozef Safarik University at 1 site in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03511924, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.

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