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Intradialytic Resistance Training in Haemodialysis Patients (IRTHEP)

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ClinicalTrials.gov Identifier: NCT03511924
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborators:
Dialysis Services Fresenius Medical Care Slovakia
Private Health Institution Logman - Logman East
Information provided by (Responsible Party):
Jaroslav Rosenberger, Pavol Jozef Safarik University

Tracking Information
First Submitted Date  ICMJE April 13, 2018
First Posted Date  ICMJE April 30, 2018
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE January 11, 2018
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
Change in circulatory microRNA profile [ Time Frame: Before the intervention and 1-5 days after the completion of 12-week intervention ]
Blood plasma will be collected for microRNA analysis. We will try to find biomarkers for better definitions of chronic renal insufficiency and muscular adaptation following progressive resistance training. For microRNA analysis, we selected molecular biomarkers which were previously connected with regulation of the protein-energy wasting, micro-inflammation and regulation of the muscle mass and functions.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
  • Change in activity of circulatory miRNA molecules involved in TRIM63 and IGF-1 signalling pathways [ Time Frame: Before the intervention and 1-5 days after the completion of 12-week intervention ]
    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
  • Change in renal specific clinical data [ Time Frame: Before the intervention, 1-5 days after the completion of the 12-week intervention and after 3 months follow up ]
    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.
  • Change in score on the Hospital Anxiety and Depression Scale [ Time Frame: Before the intervention and 1-5 days after the completion of 12-week intervention ]
    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.
  • Change in score on the Kidney Disease Quality of Life [ Time Frame: Before the intervention and 1-5 days after the completion of 12-week intervention ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Change in lower extremity muscle strength [ Time Frame: Before the intervention and 1-5 days after the completion of 12-week intervention ]
    Change in maximal voluntary force produced during hip abduction, hip adduction and knee extension assessed by dynamometer
  • Change in score on the Kidney Disease Quality of Life [ Time Frame: Before the intervention and 1-5 days after the completion of 12-week intervention ]
    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.
  • Change in score on the Karnofsky Performance Status [ Time Frame: Before the intervention and 1-5 days after the completion of 12-week intervention ]
    The Karnofsky Performance Status (KPS) scale will be used to assess self-sufficiency and functional capacity of patients on haemodialysis. KPS determines functional impairment in the performance of activities of daily living.
  • Change in score on the Hospital Anxiety and Depression Scale [ Time Frame: Before the intervention and 1-5 days after the completion of 12-week intervention ]
    The Hospital Anxiety and Depression Scale (HADS) will be used to assess states of depression and anxiety in the setting of an hospital medical outpatient clinic.
Current Other Pre-specified Outcome Measures
 (submitted: February 8, 2019)
  • Satisfaction with Life Scale [ Time Frame: 1-5 days before the intervention ]
    The Satisfaction With Life Scale will be used for measurements of the life satisfaction component of subjective well-being.
  • Multidimensional Scale of Perceived Social Support [ Time Frame: 1-5 days before the intervention ]
    The Multidimensional Scale of Perceived Social Support will be used to measure how much support a parent feels they get from family, friends and significant others.
  • Health literacy [ Time Frame: 1-5 days before the intervention ]
    The Health literacy level will be assessed using The Health Literacy Questionnaire and The Brief Health Literacy survey. This questionnaire comprises nine domains to provide a detailed profile of health literacy of populations, groups or patients of interest. The HLQ is divided into two parts which differ in response categories. Part 1 (domains 1-5) has 4 response categories rating the extent of agreement from 1 to 4. Part 2 (domains 6-9) has 5 response categories rating the level of difficulty from cannot do or always difficult (1), to always easy (5). Each domain was scored as the average of the item scores. The score ranges from 1 to 4 or 1 to 5 respectively, a higher score indicating higher level of health literacy.
  • Karnofsky Performance Status [ Time Frame: 1-5 days before the intervention ]
    The Karnofsky Performance Status (KPS) scale will be used to assess self-sufficiency and functional capacity of patients on haemodialysis. KPS determines functional impairment in the performance of activities of daily living.
  • Subjective Global Assessment [ Time Frame: 1-5 days before the intervention ]
    The nutritional status of patients will be assessed by Subjective Global Assessment method.
Original Other Pre-specified Outcome Measures
 (submitted: April 27, 2018)
Health literacy [ Time Frame: Before the intervention ]
The Health literacy level will be assessed using The Health Literacy Questionnaire (HLQ). This questionnaire comprises nine domains to provide a detailed profile of health literacy of populations, groups or patients of interest. The HLQ is divided into two parts which differ in response categories. Part 1 (domains 1-5) has 4 response categories rating the extent of agreement from 1 to 4. Part 2 (domains 6-9) has 5 response categories rating the level of difficulty from cannot do or always difficult (1), to always easy (5). Each domain was scored as the average of the item scores. The score ranges from 1 to 4 or 1 to 5 respectively, a higher score indicating higher level of health literacy.
 
Descriptive Information
Brief Title  ICMJE Intradialytic Resistance Training in Haemodialysis Patients
Official Title  ICMJE Effect of Intradialytic Resistance Training on Circulatory miRNA Profile and Muscle Strength in Haemodialysis Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Kidney Disease Requiring Chronic Dialysis
Intervention  ICMJE Behavioral: 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).
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Intradialytic resistance training
  • No Intervention: 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.
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2019)
90
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2018)
50
Actual Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03511924
Other Study ID Numbers  ICMJE PJSU-JR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jaroslav Rosenberger, Pavol Jozef Safarik University
Study Sponsor  ICMJE Pavol Jozef Safarik University
Collaborators  ICMJE
  • Dialysis Services Fresenius Medical Care Slovakia
  • Private Health Institution Logman - Logman East
Investigators  ICMJE Not Provided
PRS Account Pavol Jozef Safarik University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP