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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
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.
Satasairaala Hospital
Pori, Finland
NOT_YET_RECRUITINGTurku University Hospital
Turku, Finland
RECRUITINGVaasa Central Hospital
Vaasa, Finland
RECRUITINGHospitalisations
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Mortality
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Major Adverse Cardiovascular or Cerebrovascular Event (MACCE)
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Emergency Department Visits
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
6-minute Walking Test Distance
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Renal Replacement Therapy
start of dialysis or kidney transplantation
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Compliance to the home training program
Compliance of the intervention group assessed at every clinical control visit and tri-monthly by telephone.
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Maximal oxygen uptake in the exercise stress test
Measured by spiroergometry (adjusted by body weight ml/kg/min)
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Change in Quality of life
Measured by RAND-36 questionnaire (8 domains and 2 composite scores, scale 0-100, higher score indicating better quality of life)
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Bone fractures
Number of participants with incident fractures, total number of fractures
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
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