Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT01561118
Eligibility Criteria:
Inclusion Criteria:
* End stage renal disease with need of renal replacement therapy
* children and adolescents aged ≥6 to ≤19 years
* maintenance hemodialysis for at least 3 months
* Stable and appropriate dialysis condition in the last 4 weeks before inclusion to the study (basically stable blood and dialysate flow rate and same dialyser)
* single pool Kt/V according to Dialysestandard 2006 \> 1.2
* Informed consent
Exclusion Criteria:
* Participation in another interventional clinical trial
* severe primary neurologic, orthopaedic or cardiac disease, or secondary disease known as a contraindication for endurance training
* uncontrolled hyper- or hypotension, or cardiac disease
* Recurrent uncontrolled epileptic seizures
* dialysis shunt at the lower limbs
* pregnancy
* already planned medical intervention, for example living donor kidney transplantation or any other surgery, within the first period of the trial which will cause cancelation of more then 3 training units in a row
* Subjects who are in dependency to the sponsor or the PI of the trial, or confined to an institution on judicial or official behalf
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
19 Years
Study:
NCT01561118
Study Brief:
Protocol Section:
NCT01561118