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NCT Number: NCT06935786

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Satasairaala Hospital, Pori, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

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.

Other names: physical training education program

Primary outcomes

  1. Hospitalisations

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

  2. Mortality

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

  3. Major Adverse Cardiovascular or Cerebrovascular Event (MACCE)

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

  4. Emergency Department Visits

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

  5. 6-minute Walking Test Distance

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

  6. Renal Replacement Therapy

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

    start of dialysis or kidney transplantation

  7. Compliance to the home training program

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

    Compliance of the intervention group assessed at every clinical control visit and tri-monthly by telephone.

Secondary outcomes

  1. Maximal oxygen uptake in the exercise stress test

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

    Measured by spiroergometry (adjusted by body weight ml/kg/min)

  2. Change in Quality of life

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

    Measured by RAND-36 questionnaire (8 domains and 2 composite scores, scale 0-100, higher score indicating better quality of life)

  3. Bone fractures

    Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031

    Number of participants with incident fractures, total number of fractures

Study contacts

Contact information is provided by the study sponsor or research team.

Markus Hakamäki, MD, PhD

CONTACT

[email protected]

+35823130000

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Satasairaala
  • Vaasa Central Hospital, Vaasa, Finland

Registry information

Official study 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

Acronym: SEDKID

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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