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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Frailty; Chronic Kidney Disease
• Intervention / Treatment: Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Markus Hakamäki, MD, PhD; Phone Number: +35823130000; Email: markus.hakamaki@tyks.fi

Study Locations

• Finland
  • Pori, Finland, 28500
    • Not yet recruiting
    • Satasairaala Hospital
  • Turku, Finland, 20520
    • Recruiting
    • Turku University Hospital
  • Vaasa, Finland, 65130
    • Recruiting
    • Vaasa Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
Experimental: Exercise Program	Behavioral: 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.; Other Names: physical training education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalisations		1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Mortality		1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Major Adverse Cardiovascular or Cerebrovascular Event (MACCE)		1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Emergency Department Visits		1 year, 2 years, 3 years, 5 years, 31 Dec 2031
6-minute Walking Test Distance		1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Renal Replacement Therapy	start of dialysis or kidney transplantation	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.	1 year, 2 years, 3 years, 5 years, 31 Dec 2031

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal oxygen uptake in the exercise stress test	Measured by spiroergometry (adjusted by body weight ml/kg/min)	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)	1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Bone fractures	Number of participants with incident fractures, total number of fractures	1 year, 2 years, 3 years, 5 years, 31 Dec 2031

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Satasairaala; Vaasa Central Hospital, Vaasa, Finland
• Investigators: Principal Investigator: Tapio Hellman, MD, PhD, Turku University Hospital and University of Turku; Principal Investigator: Mikko J Järvisalo, MD, PhD, Satasairaala Hospital, Wellbeing Services County of Satakunta

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Quality of Life; Chronic Kidney Disease; Mortality; Frailty; Renal Replacement Therapy; Exercise Program; Emergency Department Visit; Hospitalisations; Major Adverse Cardiovascular and Cerebrovascular Events
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Frailty; Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: T1451/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No