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Fit for kidney transplantation through comprehensive rehabilitation

A controlled clinical trial of an interdisciplinary treatment approach in elderly dialysis patients on the waitlist for transplantation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10421131
Enrollment
150
Registered
2022-06-16
Start date
2020-11-20
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease stage 5 on dialysis Urological and Genital Diseases Chronic kidney disease stage 5

Interventions

Current interventions as of 22/01/2025: Patients in the intervention group undergo a baseline assessment followed by a three-week inpatient rehabilitation program tailored to an individualized treat

Sponsors

Bavarian State Office for Health and Food Safety
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of dialysis-dependent chronic kidney disease 2. Being on the waiting list for a kidney transplant at the Erlangen-Nuremberg Transplant Centre 3. Aged 65 years or older 4. Agrees to participate in the trial and signs the participation

Exclusion criteria

Exclusion criteria: 1. Not listed on the waiting list for a kidney transplant at the Erlangen-Nuremberg Transplant Centre 2. Severe disease or dysfunction that make participation impossible

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 22/01/2025: Body composition measured using InBody 270 and waist circumstance at baseline and after every 6 months until the end. _____ Previous primary outcome measure: Transplantability status (transplantable, not transplantable, pre-waiting list, removed) measured using patient records over the entire duration of the study

Secondary

MeasureTime frame
Current secondary outcome measures as of 22/01/2025: 1. Physical performance measured using the sit to stand Test (60), the 6-Minute-Walking-Test, the Berg-Balance-Scale, the frailty scale (Fried) and the timed up and go Test at baseline and after every 6 months until the end. 2. Degree of independence measured by the Barthel Index at baseline and after every 6 months until the end. 4. Nutritional status measured using blood parameters (HbA1c, potassium, calcium, phosphate, vitamin D, parathyroid hormone, erythrocytes, albumin, CRP, CK, ferritin,) at baseline and after every 6 months until the end. 5. Bone health measured using high-resolution peripheral quantitative CT at baseline and after every 12 months until the end. _____ Previous secondary outcome measures: 1. Physical performance measured using the sit to stand Test (60), the 6-Minute-Walking-Test, the Berg-Balance-Scale, the frailty scale (Fried) and the timed up and go Test at baseline, after three weeks and after every 6 months until the end. 2. Body composition measured using InBody 270 and waist circumstance at baseline, after three weeks and after every 6 months until the end. 3. Quality of life measured using Sf-12 at baseline and after every 6 months until the end. 4. Nutritional status measured using blood parameters (HbA1c, cholesterol, LDL, HDL triglycerides, potassium, sodium, chloride, magnesium, gGT, GOT, GPT, AP, calcium, phosphate, vitamin D, parathormone, erythrocytes, reticulocytes, ferritin, total protein, albumin, vitamin B12, folic acid and protein electrophoresis) at baseline and after every 6 months until the end. 5. Bone health measured using high-resolution peripheral quantitative CT at baseline and after every 6 months until the end.

Countries

Germany

Contacts

Public ContactHelge;Judith Krusemark;Kleemann

;

Helge.krusemark@uk-erlangen.de;Judith.Kleemann@uk-erlangen.de+49 9131 85 42966;+49 9131 85 43086

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026