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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorTurku University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >40 years

Estimated glomerular filtration rate < 20ml/min/1.73m2 (CKD stage 4-5)

Informed consent from the patient is received

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Exercise ProgramExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Turku University Hospital

Lead sponsor

Satasairaala

Collaborator

Vaasa Central Hospital, Vaasa, Finland

Collaborator