An interventional study of Functional training and cycling and Cycling in Physical Activity, Kidney Diseases and Kidney Failure, sponsored by University Medical Centre Ljubljana. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-05-11.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Supportive care
Among 13 studies in Kidney Failure, Chronic with a site in Slovenia — 2 open to participants now, 2 under way, none of them phase 3. Kidney Failure, Chronic · Slovenia.
Among the 13 studies in Kidney Failure, Chronic with a site in Slovenia, this one is the 4th largest by planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2017, is one of 8 with no phase, and was the 5th registered.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
Browse Kidney Failure, Chronic studies →2 of the 13 studies in Kidney Failure, Chronic with a site in Slovenia are open now. Recruiting first, the newest first:
Rigshospitalet, Denmark · Sites in Slovenia, Argentina, Austria and 33 more countries
University Medical Centre Ljubljana · Sites in Slovenia
A study can be open while its sites in Slovenia have not opened yet or have stopped. Only those recruiting at a site in Slovenia →
Of the 170 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 1 started in 2017.
This study's planned enrollment of 86 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Median enrollment 50 across the 11 interventional studies, 12,543 across the 2 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 13 have an industry lead sponsor. The 8 most frequent:
University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
University Medical Centre Ljubljana has 6 studies filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
1 of the studies in Kidney Failure, Chronic with a site in Slovenia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07618858University Medical Centre LjubljanaComparison of Citrate and Heparin Anticoagulation During Postdilution Hemodiafiltration | 2026-12-15 |
Among the 13 studies in Kidney Failure, Chronic with a site in Slovenia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The aim of the study is to determine the effect of functional exercise and training counseling by kinesiotherapist in addition to the basic exercise program of cycling during dialysis on physical performance of dialysis patients.
Study will include 86 dialysis patients. Investigators will first test the strength of lower limbs with sit-to-stand test, handgrip strength, flexibility, balance, submaximal aerobic capacity, physical characteristics and clinical parameters. After that randomization of patients in two groups will be made - one experimental and one active control group. Patients who will refuse to exercise will be invited to a non-randomized inactive control group (without exercise).
The experimental group will attend 3 times weekly a guided functional exercise before the dialysis procedure for 20 minutes and perform a cycling session during dialysis in the first phase of the study, which will last for 8 weeks. During this time experimental group will receive exercise counselling; instructions how to practice at home will be given by examples and training during functional exercise predialysis sessions.
In the second phase of the study for additional eight weeks participants will be instructed to exercise at home using the skills mastered during the first study phase on non-dialysis days, and continue with the program of intradialysis cycling. Investigators will give them advice, monitor and motivate them.
The active control group will perform intradialytic exercise (intradialysis cycling equal to cycling program of experimental group) during dialysis procedure for four months.
The primary end-point of the study is a change in the 10-repetition sit-to-stand test time as a measure of strength of lower extremities.
Exercise program will be run by a kinesiologist. Main hypothesis is that the guided functional exercise under the surveillance of a kinesiologist added to intradialysis cycling program statistically significantly improves patient's physical performance as compared to the program of intradialysis cycling alone.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 86 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will perform 20 minutes of functional training before dialysis (in the first 8 weeks) and intradialysis cycling exercise during dialysis. Participants will also receive exercise counselling; investigators will teach them how to practice at home by practice and examples given during the 20 minutes of functional training pre-dialysis. In the second phase of additional eight weeks participants will perform the functional training at home on non-dialysis days in addition to intradialysis cycling. Kinesiologist will monitor, advice and motivate them.
Other: Functional training and cycling
This active control comparator group will perform intradialytic cycling on an adapted ergometer 3 times per week for 4 months without functional training prior to dialysis procedure and without exercise counselling.
Other: Cycling
First 8 weeks: patients will perform 20 minutes of functional training before their dialysis procedure. The exercise program will be run by kinesiologists, who will also teach patients how to perform exercises on their own at home. During intradialysis cycling 3 times weekly participants will cycle on adapted ergometer. Participants will start with 10 - 15 minutes of cycling and then gradually increase time and intensity up to 45 minutes of duration. Second phase of 8 weeks: participants will no longer perform functional training before dialysis but will be motivated, monitored and advised to perform functional exercise at home on non-dialysis days for 20-30 minutes and continue with cycling sessions during the dialysis procedures three times weekly.
Also known as: Functional training, intradialysis cycling and counselling, Experimental group
First 8 weeks: cycling on an adapted ergometer during dialysis; starting with 10 - 15 minutes of cycling and then gradually increasing time and intensity up to 45 minutes of duration. Second 8 weeks: continue with cycling at the target duration and intensity during dialysis.
Also known as: Intradialysis cycling exercise, Active control group
Change in 10 repetition sit-to-stand test time
Performance of the sit-to-stand test involves activation of the lower limb muscles; the test measures lower limb strength. Participants are required to 10 times stand up from and sit down on an armless chair as quickly as possible. Their arms should be folded across their chest.
Time frame: baseline, 8 weeks and 16 weeks
Change in 6-minute walk test distance
Distance made in 6-minute walk test (submaximal aerobic endurance)
Time frame: baseline, 8 weeks and 16 weeks
Change in lean and fat body mass
Body composition measurements by bioimpedance
Time frame: baseline, 8 weeks and 16 weeks
Change in serum interleukin-6 (IL-6)
Predialysis serum concentration of IL-6 as a measure of inflammation
Time frame: baseline, 8 weeks and 16 weeks
Change in Stork balance test time
Stork balance test time as a measure of balance
Time frame: baseline, 8 weeks, 16 weeks
Change in sit-and-reach test distance
Sit-and-reach test distance as a measure of flexibility
Time frame: baseline, 8 weeks, 16 weeks
Plan to share: Undecided
Started Nov 2017 (actual). Primary completion is estimated for Apr 2019, 16 months after the start.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 16 months is below that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Medical Centre Ljubljana →