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| Name | Class |
|---|---|
| m&i Fachklinik Bad Heilbrunn | UNKNOWN |
| Carealytix Digital Health GmbH | UNKNOWN |
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This study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). The aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation in comparison to a control group.
Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning after 6 months and after 12 months regarding their body composition, physical performance, blood values, quality of life and nutritional status. The control group only receives support via app during the study period (1 year), through which they receive detailed information about dialysis. In addition to access to the app, the intervention group receives individual recommendations for nutrition and exercise as well as a three-week inpatient rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | App-assisted three-week comprehensive rehabilitation individual support in nutrition and exercise |
|
| Control | Active Comparator | usual care App-assisted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive individual support in nutrition and exercise | Behavioral | Intensive care for nutrition and exercise adapted to the social context. Individualised exercise and nutrition recommendations. three weeks of inpatient rehabilitation with an individual plan of treatment, which includes medical care, sports therapy, physiotherapy, ergotherapy, nutritional education and psychological care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.) |
| Measure | Description | Time Frame |
|---|---|---|
| muscle mass | measured in kg by bio-impedance analysis | 6 and 12 month |
| body fat mass | measured in kg by bio-impedance analysis | 6 and 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Six-Minutes-Walk test (6MWT) | measured in distance (meter) | 6 and 12 month |
| Sit-to-stand test (STS60) | measured in number of repetitions in 60 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helge Krusemark | Contact | +4991318542966 | helge.krusemark@uk-erlangen.de | |
| Judith Kleemann | Contact | +4991318543086 | judith.kleemann@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Mario Schiffer, Prof. | Universitätsklinikum Erlangen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen | Recruiting | Erlangen | Bavaria | 91054 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40841967 | Derived | Krusemark H, Kleemann J, Weigand J, Kannenkeril D, Heller K, Hepp T, Albersmeyer M, Gerbig D, Schiffer M. A randomized, controlled, 12-month trial on the effects of an interdisciplinary treatment approach in ESRD patients: study protocol of the smart and fit for kidney transplantation trial (S&F4KTx). Trials. 2025 Aug 21;26(1):298. doi: 10.1186/s13063-025-09022-2. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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Random assignment in 1:1 ratio to either the intervention group (app-assisted, individual support in nutrition and exercise, three-week comprehensive rehabilitation) or control group (Usual care and app-assisted)
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|
| Usual Care | Behavioral | Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.) |
|
| 6 and 12 month |
| Timed-up-and-go test (TUG) | measured in time (seconds) | 6 and 12 month |
| Quality of life by Short Form Health Survey (SF-12) | measured in change of scale by questionnaire | 6 and 12 month |
| Fried Frailty Scale | measured in change of score (score of 0 = not frail; score of 1-2 = pre-frail; score of 3-5 = frail) | 6 and 12 month |
| One-Legged Stance Test | measured in time (seconds) | 6 and 12 month |
| Stair Climb Test | measured in time (seconds) | 6 and 12 month |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |