Fit for kidney transplantation through comprehensive rehabilitation
| ISRCTN | ISRCTN10421131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10421131 |
| Secondary identifying numbers | GE8-2496-IMV-19-V2 |
- Submission date
- 19/07/2021
- Registration date
- 16/06/2022
- Last edited
- 22/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Elderly patients on the kidney transplant waiting list often experience a decline in physical and mental performance and an increase in frailty over time, potentially jeopardizing their transplant eligibility. A comprehensive rehabilitation program with ongoing support aims to help these patients remain active, independent, and optimally prepared for transplantation. This study seeks to evaluate whether such a program can enhance physical and mental performance while reducing cardiac events and other comorbidities before transplantation.
Who can participate?
Adults aged 65 years or older with a diagnosis of dialysis-dependent end-stage renal disease (ESRD) who are registered on the kidney transplant waiting list at the Transplantation Center Erlangen-Nuremberg are eligible for participation.
What does the study involve?
Participants will receive an informational sheet and an appointment for the baseline visit. During this visit, they will provide informed consent and sign a privacy agreement. Subsequently, they will undergo physical fitness tests, blood sampling, a micro-CT scan to assess bone density, and an evaluation of their nutritional status. Following this baseline assessment, participants will engage in a three-week inpatient comprehensive rehabilitation program. Upon completion of the program, their physical fitness and nutritional status will be reassessed, and they will receive a personalized training regimen and dietary recommendations. Baseline assessments will be repeated every six months.
What are the possible benefits and risks of participating?
Participants may benefit from improved physical function, quality of life, body composition, bone density, and laboratory parameters. Additional potential benefits include enhanced post-transplant recovery, reduced wound healing complications, and a lower incidence of delayed graft function. Furthermore, the findings from this study may inform future care strategies for patients with similar conditions.
There are no additional risks for the patients.
Where is the study run from?
University of Erlangen-Nuremberg, Department of Medicine, Medicine 4 (Germany)
When is the study starting and how long is it expected to run for?
June 2020 to May 2025
Who is funding the study?
Bavarian State Office for Health and Food Safety (Germany)
Who is the main contact?
Helge Krusemark
Helge.Krusemark@uk-erlangen.de
Contact information
Scientific
Ulmenweg 18
Erlangen
91054
Germany
 ORCID ID |
0000-0002-8414-1470 |
|---|---|
| Phone | +49 9131 85 39002 |
| Mario.Schiffer@uk-erlangen.de |
Public
Ulmenweg 18
Erlangen
91054
Germany
| Phone | +49 9131 85 42966 |
|---|---|
| Helge.krusemark@uk-erlangen.de |
Public
Ulmenweg 18
Erlangen
91054
Germany
| Phone | +49 9131 85 43086 |
|---|---|
| Judith.Kleemann@uk-erlangen.de |
Study information
| Study design | Single-center non randomized and non controlled longitudinal interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | 40184_PIS_25Mar2021.pdf |
| Scientific title | A controlled clinical trial of an interdisciplinary treatment approach in elderly dialysis patients on the waitlist for transplantation |
| Study acronym | Fit4KTX |
| Study hypothesis | An interdisciplinary treatment approachment (exercise, nutrition, psychosomatics) compared to the control group 1. leads to a permanent “transplantable” waitlist-status 2. improves the physical performance and self-sufficiency 3. improves blood parameters, bone volume and bone mineral density 4. reduces cardiovascular events 5. improves the patients quality of life and adherence 6. before KTx reduces wound healing disturbances and the incidence of a delayed graft function after KTx |
| Ethics approval(s) | Approved 19/11/2020, University of Erlangen-Nuremberg (Department of medicine, Krankenhausstraße 12, 91054 Erlangen, Germany; +49 9131 85 22270; ethikkomission@fau.de) ref: 438_20 B |
| Condition | Chronic kidney disease stage 5 on dialysis |
| Intervention | 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 treatment plan. This plan encompasses medical care, sports therapy, physiotherapy, occupational therapy, nutritional education, and psychological support. Upon completion of the intensive three-week program, patients receive exercise and nutritional recommendations designed for implementation at home and/or during dialysis sessions. Follow-up assessments conclude at the end of the study period, with evaluations of physical performance and frailty conducted semiannually post-intervention. Patients in the control group are assessed only at baseline and during follow-up assessments conducted every six months. The total study duration per patient is 2 years. _____ Previous interventions: The patients, who are in the intervention group, get a baseline assessment and take part in a three week inpatient rehabilitation with an individual plan of treatment, which includes medical care, sports therapie, physiotherapie, ergotherapie, nutritional education and psychological care. After these three weeks of intensive care, the patients get exercise and nutritional advices, which they can implement at home and/or at the dialysis. The follow up ends at the end of the trial. Every half year after the intervention, the assessment of physical performance and frailty will be repeated. The patients who are in the control group are only examined at the beginning and in the follow up after every 6 months |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/06/2020 |
| Overall study end date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 150 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 20/11/2020 |
| Recruitment end date | 31/12/2023 |
Locations
Countries of recruitment
- Germany
Study participating centre
Ulmenweg 18
Erlangen
91054
Germany
Sponsor information
Government
Prinzregentenstraße 6
Bad Kissingen
97688
Germany
| Phone | +49 9131 6808-7209 |
|---|---|
| IMV-Foerderung@lgl.bayern.de | |
| Website | https://www.lgl.bayern.de/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 25/03/2021 | 29/07/2021 | No | Yes |
Additional files
Editorial Notes
22/01/2025: The following changes were made to the trial record:
1. The study design was changed from "Single-center controlled interventional trial" to "Single-center non randomized and non controlled longitudinal interventional trial".
2. The overall end date was changed from 31/05/2026 to 31/05/2025.
3. The interventions were changed.
4. The primary outcome measure was changed.
5. The secondary outcome measures were changed.
6. The intention to publish date was changed from 31/08/2026 to 31/08/2025.
7. The plain English summary was updated to reflect these changes.
30/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2023 to 31/12/2023.
2. The overall end date was changed from 31/05/2023 to 31/05/2026.
3. The intention to publish date was changed from 31/08/2023 to 31/08/2026.
4. The plain English summary was updated to reflect these changes.
29/07/2021: Trial's existence confirmed by University of Erlangen-Nuremberg.
