Smart and Fit for Kidney Transplantation

Официальное название

The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое intensive individual support in nutrition and exercise
  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.)
• Поведенческое Usual Care
  Usual care App access for comprehensive information about dialysis (nutrition, travel, medication, etc.)

Первичные конечные точки

• muscle mass [Срок оценки: 6 and 12 month]
• body fat mass [Срок оценки: 6 and 12 month]

Вторичные конечные точки (7)

• Six-Minutes-Walk test (6MWT) [Срок оценки: 6 and 12 month]
• Sit-to-stand test (STS60) [Срок оценки: 6 and 12 month]
• Timed-up-and-go test (TUG) [Срок оценки: 6 and 12 month]
• Quality of life by Short Form Health Survey (SF-12) [Срок оценки: 6 and 12 month]
• Fried Frailty Scale [Срок оценки: 6 and 12 month]
• One-Legged Stance Test [Срок оценки: 6 and 12 month]
• Stair Climb Test [Срок оценки: 6 and 12 month]

Критерии участия

Критерии включения

• Patients must be on dialysis
• Patients ≥ 18 years of age
• Patients who own a smartphone
• Patients must be willing to undergo inpatient rehabilitation within the project period
• signed informed consent and data protection regulation

Критерии исключения

• Patients who are not psychologically or physically able to take part in exercise promotion measures and/or nutritional counselling as well as psychological offers
• Patients who have already participated in a similar project

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Universitätsklinikum Erlangen — Erlangen

Публикации

• 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. PMID 40841967

Идентификаторы

NCT: NCT06040281 · GE8-2496-IMV-2019-V2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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