Intradialytic Resistance Training in Haemodialysis Patients (IRTHEP)
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|ClinicalTrials.gov Identifier: NCT03511924|
Recruitment Status : Active, not recruiting
First Posted : April 30, 2018
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Requiring Chronic Dialysis||Behavioral: Intradialytic resistance training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Intradialytic Resistance Training on Circulatory miRNA Profile and Muscle Strength in Haemodialysis Patients|
|Actual Study Start Date :||January 11, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
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).
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.
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511924
|Fresenius Medical Care - Dialysis Services Košice, Slovakia|
|Košice, Slovakia, 04011|