Chronic Kidney DiseaseSEDKIDNCT06935786
SEDentary Lifestyle, Mortality and Major Adverse Clinical Outcomes in Chronic KIDney Disease
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Chronic Kidney Disease and Cardiovascular Diseases, run by Turku University Hospital at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Kidney Disease, Cardiovascular Diseases, Frailty
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesFinland
- Study dates
- 21 Feb 2025to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >40 years
- Estimated glomerular filtration rate < 20ml/min/1.73m2 (CKD stage 4-5)
- Informed consent from the patient is received
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland3 sites, 3 recruiting
- Not yet recruiting
Satasairaala Hospital
Pori, 28500
- Recruiting
Turku University Hospital
Turku, 20520
- Recruiting
Vaasa Central Hospital
Vaasa, 65130
About this study
Official 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
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.
Read the 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
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Keywords
- Chronic Kidney Disease, Cardiovascular Diseases, Renal Replacement Therapy, Frailty, Mortality, Hospitalisations, Exercise Program, Quality of Life, Emergency Department Visit, Major Adverse Cardiovascular and Cerebrovascular Events
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONBehavioural
Also called physical training education program
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Experimental | Not described Receives: Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalisations
Measured: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Mortality
Measured: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Major Adverse Cardiovascular or Cerebrovascular Event (MACCE)
Measured: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Emergency Department Visits
Measured: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
6-minute Walking Test Distance
Measured: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Renal Replacement Therapy
start of dialysis or kidney transplantation
Measured: 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.
Measured: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Secondary outcomes (3)
Maximal oxygen uptake in the exercise stress test
Measured by spiroergometry (adjusted by body weight ml/kg/min)
Measured: 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)
Measured: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Bone fractures
Number of participants with incident fractures, total number of fractures
Measured: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start21 Feb 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Satasairaala, Vaasa Central Hospital, Vaasa, Finland
- Responsible party
- Sponsor
- Investigators
- Tapio Hellman, MD, PhD, Principal investigator, Turku University Hospital and University of TurkuMikko J Järvisalo, MD, PhD, Principal investigator, Satasairaala Hospital, Wellbeing Services County of Satakunta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935786
- Sponsor's protocol ID
- T1451/2023
- Acronym
- SEDKID
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06935786
- Acronym / sponsor ID
- SEDKID / T1451/2023
- Conditions
- Chronic Kidney Disease, Cardiovascular Diseases, Frailty
- Keywords
- Chronic Kidney Disease, Cardiovascular Diseases, Renal Replacement Therapy, Frailty, Mortality, Hospitalisations, Exercise Program, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Satasairaala, Vaasa Central Hospital, Vaasa, Finland
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Experimental | Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >40 years
- Estimated glomerular filtration rate < 20ml/min/1.73m2 (CKD stage 4-5)
- Informed consent from the patient is received
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONAlso: physical training education programSingle 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. | Behavioural | Exercise Program |
Primary outcome
Hospitalisations
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
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
start of dialysis or kidney transplantation
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.
3 secondary outcomes
Maximal oxygen uptake in the exercise stress test
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Change in Quality of life
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Bone fractures
Time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tapio Hellman, MD, PhD principal investigator
Turku University Hospital and University of Turku
Mikko J Järvisalo, MD, PhD principal investigator
Satasairaala Hospital, Wellbeing Services County of Satakunta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Chronic Kidney Disease and Cardiovascular Diseases, run by Turku University Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Markus Hakamäki, MD, PhD (+35823130000, markus.hakamaki@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalisations (time frame: 1 year, 2 years, 3 years, 5 years, 31 Dec 2031). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.