Clinical trial NCT06935786: SEDentary Lifestyle, Mortality and Major Adverse Clinical Outcomes in Chronic KIDney Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease
Cardiovascular Diseases
Frailty
Keywords: Chronic Kidney Disease
Cardiovascular Diseases
Renal Replacement Therapy
Frailty
Mortality
Hospitalisations
Exercise Program
Quality of Life
Emergency Department Visit
Major Adverse Cardiovascular and Cerebrovascular Events
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Satasairaala
name: Vaasa Central Hospital, Vaasa, Finland
First posted: 2025-04-20
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hospitalisations
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
measure: Mortality
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
measure: Major Adverse Cardiovascular or Cerebrovascular Event (MACCE)
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
measure: Emergency Department Visits
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
measure: 6-minute Walking Test Distance
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
measure: Renal Replacement Therapy
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
measure: Compliance to the home training program
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Secondary outcomes:
measure: Maximal oxygen uptake in the exercise stress test
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
measure: Change in Quality of life
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
measure: Bone fractures
timeFrame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Other outcomes:
Locations:
city: Pori
country: Finland
facility: Satasairaala Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
Study officials:
affiliation: Turku University Hospital and University of Turku
name: Tapio Hellman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Satasairaala Hospital, Wellbeing Services County of Satakunta
name: Mikko J Järvisalo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: