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

NCT ID: NCT06935786

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-21
• Study Completion Date: 2031-12-31

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.

Conditions

Chronic Kidney Disease; Cardiovascular Diseases; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise Program

Group Type: EXPERIMENTAL

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Intervention Type: BEHAVIORAL

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.

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

physical training education program

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Satasairaala

OTHER

Sponsor Role: collaborator

Vaasa Central Hospital, Vaasa, Finland

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tapio Hellman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital and University of Turku

Mikko J Järvisalo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Satasairaala Hospital, Wellbeing Services County of Satakunta

Locations

Satasairaala Hospital

Pori, , Finland

Site Status: NOT_YET_RECRUITING

Turku University Hospital

Turku, , Finland

Site Status: RECRUITING

Vaasa Central Hospital

Vaasa, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Markus Hakamäki, MD, PhD

Role: CONTACT

markus.hakamaki@tyks.fi

+35823130000

Other Identifiers

T1451/2023

Identifier Type: -

Identifier Source: org_study_id