NCT03511924

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

April 13, 2018

Last Update Submit

March 2, 2020

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

resistance trainingcirculating miRNAmuscle strength

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (4)

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

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

  • Change in renal specific clinical data

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

  • Change in score on the Hospital Anxiety and Depression Scale

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

  • Change in score on the Kidney Disease Quality of Life

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

Other Outcomes (5)

  • Satisfaction with Life Scale

    1-5 days before the intervention

  • Multidimensional Scale of Perceived Social Support

    1-5 days before the intervention

  • Health literacy

    1-5 days before the intervention

  • +2 more other outcomes

Study Arms (2)

Intradialytic resistance training

EXPERIMENTAL

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

Control programme

NO INTERVENTION

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.

Interventions

Intradialytic resistance trainingBEHAVIORAL

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).

Intradialytic resistance training

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fresenius Medical Care - Dialysis Services Košice, Slovakia

Košice, 04011, Slovakia

Location

Related Publications (2)

  • 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.

    PMID: 23434075BACKGROUND

  • 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.

    PMID: 36859437DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jaroslav Resenberger, MD, PhD.

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 30, 2018

Study Start

January 11, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)