SEDentary Lifestyle, Mortality and Major Adverse Clinical Outcomes in Chronic KIDney Disease

Официальное название

SEDentary Lifestyle, Mortality and Major Adverse Clinical Outcomes in Chronic KIDney Disease. A Prospective Multicenter Follow-up Protocol With a Nested Randomized Controlled Trial of Physical Education Benefits - The SEDKID Study

Обзор

The goal of this study is to learn if a simple home exercise program can benefit patients with advanced chronic kidney disease. There is also an observational part of the study without an exercise program. The study will record patients' mortality, cardiovascular events, emergency department visits, hospital stays, need for dialysis and 6 minutes walking distance. Also maximal oxygen uptake, quality of life and bone fractures are recorded and blood tests and X-rays analyzed. The prospective observational part of the study will investigate the link between cardiovascular and kidney health as well as exercise capacity and adverse outcomes.

Подробное описание

The prevalence of chronic kidney disease (CKD) and patients on maintenance dialysis is increasing, and affected patients are at elevated risk of premature death and adverse cardiovascular events.

Frailty is a term used to describe aging related attenuation of physical, mental, psychological and cognitive performance. Frailty is common in patients with CKD. Frailty is associated with increased mortality, hospitalization and falls in both the general population and in CKD.

Treatment of frailty is challenging due to its multidimensional nature and the old age and comorbidity of the affected patients. In spite these challenges, physical rehabilitation and training programs have been shown to successfully improve the prognosis of patients with CKD.

The investigators hypothesize that marked frailty is associated with a weak prognosis in spite renal replacement therapy and kidney transplantation. Because advanced predialysis stage CKD carries a high risk of adverse events and kidney transplants available are scarce, it is imperative to identify those elderly CKD stage 5 patients that benefit from initiating renal replacement therapy and those who are unlikely to benefit to avoid futile intensive treatment when it does not improve prognosis or quality of life. The investigators expect that the progression of frailty may up to a point be hindered using a simple physical exercise program that can be produced cost effectively to aid a large number of patients.

The trial aims to examine the benefits of an individual physical training education program in advanced CKD. In addition to the controlled trial setting the study examines the association between measures of frailty, physical and psychological capability assessed at study inclusion (baseline) and incident hospitalization, mortality, renal replacement therapy (RRT) and major adverse cardiovascular events during follow-up.

Вмешательства

• Поведенческое EXERCISE TRAINING WITH OR WITHOUT MEDICATION
  Single appointment with a registered physiotherapist educating the patient for rehabilitating physical training and exercise to be performed independently and regularly by the patient at home, minimum of three times a week, during the study period.

Первичные конечные точки

• Hospitalisations [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]
• Mortality [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]
• Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]
• Emergency Department Visits [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]
• 6-minute Walking Test Distance [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]
• Renal Replacement Therapy [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]
• Compliance to the home training program [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]

Вторичные конечные точки (3)

• Maximal oxygen uptake in the exercise stress test [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]
• Change in Quality of life [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]
• Bone fractures [Срок оценки: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031]

Критерии участия

Критерии включения

• Age >40 years
• Estimated glomerular filtration rate < 20ml/min/1.73m2 (CKD stage 4-5)
• Informed consent from the patient is received

Критерии исключения

• Maintenance dialysis dependency before inclusion
• Pregnant women
• Patient's lack of commitment to follow-up
• Chronic or acute clinical condition with a prognosis less than 6 months
• Amputated lower limbs

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

Финляндия · 3 центра

• Satasairaala Hospital — Pori
• Turku University Hospital — Turku
• Vaasa Central Hospital — Vaasa

Идентификаторы

NCT: NCT06935786 · T1451/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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