Chronic Kidney DiseasesNCT07041554
Cardiovascular Risk Factors and Physical Activity in Chronic Kidney Patients on Peritoneal Dialysis
An observational study of Chronic Kidney Diseases and Cardiovascular Risk Factors, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study was to examine the association between cardiovascular risk factors and physical activity parameters in patients with chronic kidney disease who are treated with peritoneal dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Cardiovascular Risk Factors, Arterial Stiffness
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2025to 31 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease who are followed up by the Nephrology Outpatient Clinic of Dokuz Eylül University Research and Application Hospital and treated with peritoneal dialysis will be included in the study.
Who may be able to join
- Diagnosed with chronic kidney disease
- Peritoneal dialysis treatment for at least three months
- Age ≥ 18
Who cannot join
- Mini Mental Test Score < 24
- Serious cardiovascular, pulmonary, or neurological conditions that make it impossible to wear an accelerometer
- Inability to walk independently
- Conditions affecting participation in daily life due to lower limb injury or surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Faculty of Physical Therapy and Rehabilitation Dokuz Eylul University contact
Turkey (Türkiye)1 site
Dokuz Eylul University Faculty of Physical Therapy and Rehabilitation
Izmir, 35410
Faculty of Physical Therapy and Rehabilitation, +90 232 277 50 30, fiziktedavi@deu.edu.tr
Meriç YILDIRIM, Professor, +90 232 - 4124938 - 24938, meric.senduran@deu.edu.tr
About this study
Official title: Examination of Cardiovascular Risk Factors and Physical Activity in Chronic Kidney Patients Treated With Peritoneal Dialysis
The objective of this study was to examine the association between cardiovascular risk factors and physical activity parameters in patients with chronic kidney disease who are treated with peritoneal dialysis.
Read the detailed description
Chronic kidney disease (CKD) is defined as a progressive disease in which kidney function is permanently impaired for a period of at least three months, glomerular filtration rate falls below 60 milliliters per minute per 1.73 square meters of body surface area, and the kidneys are structurally or functionally damaged. As the kidneys' capacity to regulate fluid, electrolyte, and acid-base balance decreases substantially in the later stages of CKD, renal replacement therapy is necessary to maintain renal function. Peritoneal dialysis, a type of renal replacement therapy, involves the use of a specialized dialysis solution that is injected into the abdominal cavity to effectively remove waste materials and excess fluids from the body.
The risk of cardiovascular disease is higher in peritoneal dialysis (PD) patients compared to the general population. Therefore, it is critical to identify these risk factors and develop effective interventions to reduce the risk of mortality, increase adherence to treatment, and improve quality of life. Arterial stiffness, a pivotal factor, has been shown to markedly elevate the risk of cardiovascular disease in PD patients and is associated with fluid overload and vascular calcification.
Physical activity plays a significant role in the reduction of cardiovascular risk factors in patients with PD. Regular exercise has been shown to improve cardiovascular health, control obesity, lower blood pressure, improve lipid profile, enhance insulin sensitivity, and increase overall physical activity levels. Consequently, these factors contribute to a reduction in cardiovascular disease (CVD) risk in PD patients. A notable study has concluded that physical activity plays a pivotal role in cardiovascular health and possesses the potential to reduce the risk of cardiovascular disease (CVD) in kidney transplant patients. Notably, studies have highlighted that physical activity levels in peritoneal dialysis patients are often suboptimal due to socio-demographic factors, fatigue, pain, psychological problems, and a lack of knowledge about exercise. This underscores the need for further research in this area to elucidate effective strategies for promoting physical activity and enhancing cardiovascular health in PD patients.
The present study will include individuals with chronic kidney disease who are followed up by the Nephrology Outpatient Clinic of Dokuz Eylül University Research and Application Hospital and treated with peritoneal dialysis. The objective of the study is to examine the relationship between cardiovascular risk factors and physical activity parameters in chronic kidney disease patients treated with peritoneal dialysis. Patients who meet the specified criteria will be included in the study. A comprehensive collection of sociodemographic and clinical information will be conducted, followed by an evaluation of cardiovascular risk factors. Heart rate, blood pressure, waist circumference, body mass index, laboratory findings (lipid profile [total cholesterol level, LDL and HDL cholesterol, triglycerides], fasting glucose value, HbA1C value, hemoglobin, CRP, proteinuria, glomerular filtration rate (GFR)), smoking history, and risk percentage will be determined with the HeartScore scoring system. The IEM Mobil-O-Graph® device will be used for arterial stiffness measurement. The physical activity parameters will be evaluated using an accelerometer (Sensewear Armband device), and the relationship between them will be analyzed.
- Conditions
- Chronic Kidney Diseases, Cardiovascular Risk Factors, Arterial Stiffness, Physical Activity
- Keywords
- cardiovascular risk factors, physical activity, arterial stiffness, accelerometer, peritoneal dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease Patients Treated with Peritoneal Dialysis | The study will examine cardiovascular risk factors and physical activity parameters in a sample of 23 participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Physical Activity Level
Physical activity is defined as any body movement that results in the body expending more energy than its basal level of energy expenditure, due to skeletal muscle contraction. The assessment of physical activity levels will be conducted using the SenseWear Armband (SWK). The SWK will be used to obtain several pieces of information, including the number of steps, total energy expenditure (in calories), average day and night sleep time (in minutes), average day and night reaching time (in minutes), average metabolic equivalent (MET), active energy expenditure (in calories) consumed during moderate (3 MET) physical activity, and physical activity duration (in minutes, 3 MET). Subjects will be requested to utilize the device for a period of seven consecutive days.
Measured: Seven days
Arterial Stiffness Measurement
Arterial stiffness represents the viscoelastic properties of the vessel wall, indicates vascular damage, and is a measure of the degree of atherosclerosis. Increased arterial stiffness or decreased compliance indicates diffuse atherosclerotic involvement of the vasculature. One of the non-invasive techniques used to assess arterial stiffness is pulse wave analysis (PWA). PWA examines the pressure waveforms in the major arteries. Pulse wave velocity (PWV) and amplification index (Alx) are indices of arterial stiffness.PWV is the velocity of the pulse propagating along the arterial segment. Alx is the ratio of the difference between the late systolic pressure reflected from the periphery and the early systolic pressure to the pulse pressure and is expressed as a percentage. The IEM Mobil-O-Graph® device is used to assess arterial stiffness.
Measured: 1 day
Assessment of Cardiovascular Risk Factors
The following health metrics will be evaluated using the HeartScore scoring system to determine risk percentage: heart rate, blood pressure, waist circumference, body mass index, lipid profile (total cholesterol level, LDL and HDL cholesterol, triglycerides), fasting glucose value, HbA1C value, hemoglobin, CRP, proteinuria, smoking history, and glomerular filtration rate (GFR).The HeartScore system is a web-based risk prediction and management program that aims to support clinicians in optimizing individual cardiovascular risk reduction. The HeartScore web-based program utilizes a sophisticated algorithm to calculate the 10-year cardiovascular mortality risk based on age, gender, smoking habits, blood pressure, blood cholesterol, and the total cholesterol/HDL ratio. The European (High and Low) and National versions are currently available. However, the program is designed by national cardiology associations to be adapted to the local conditions of the countries.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start23 Jun 2025 (estimated)
- Primary completion2 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayten Demir, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041554
- Sponsor's protocol ID
- DEU-FTR-AE-02
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The reason for not sharing data is the concern about unauthorized use.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Cardiovascular Risk Factors and Physical Activity in Chronic Kidney Patients Treated With Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT07041554
- Acronym / sponsor ID
- DEU-FTR-AE-02
- Conditions
- Chronic Kidney Diseases, Cardiovascular Risk Factors, Arterial Stiffness, Physical Activity
- Keywords
- cardiovascular risk factors, physical activity, arterial stiffness, accelerometer, peritoneal dialysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 23 Jun 2025 (estimated)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jun 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 objective of this study was to examine the association between cardiovascular risk factors and physical activity parameters in patients with chronic kidney disease who are treated with peritoneal dialysis.
Detailed description
Chronic kidney disease (CKD) is defined as a progressive disease in which kidney function is permanently impaired for a period of at least three months, glomerular filtration rate falls below 60 milliliters per minute per 1.73 square meters of body surface area, and the kidneys are structurally or functionally damaged. As the kidneys' capacity to regulate fluid, electrolyte, and acid-base balance decreases substantially in the later stages of CKD, renal replacement therapy is necessary to maintain renal function. Peritoneal dialysis, a type of renal replacement therapy, involves the use of a specialized dialysis solution that is injected into the abdominal cavity to effectively remove waste materials and excess fluids from the body.
The risk of cardiovascular disease is higher in peritoneal dialysis (PD) patients compared to the general population. Therefore, it is critical to identify these risk factors and develop effective interventions to reduce the risk of mortality, increase adherence to treatment, and improve quality of life. Arterial stiffness, a pivotal factor, has been shown to markedly elevate the risk of cardiovascular disease in PD patients and is associated with fluid overload and vascular calcification.
Physical activity plays a significant role in the reduction of cardiovascular risk factors in patients with PD. Regular exercise has been shown to improve cardiovascular health, control obesity, lower blood pressure, improve lipid profile, enhance insulin sensitivity, and increase overall physical activity levels. Consequently, these factors contribute to a reduction in cardiovascular disease (CVD) risk in PD patients. A notable study has concluded that physical activity plays a pivotal role in cardiovascular health and possesses the potential to reduce the risk of cardiovascular disease (CVD) in kidney transplant patients. Notably, studies have highlighted that physical activity levels in peritoneal dialysis patients are often suboptimal due to socio-demographic factors, fatigue, pain, psychological problems, and a lack of knowledge about exercise. This underscores the need for further research in this area to elucidate effective strategies for promoting physical activity and enhancing cardiovascular health in PD patients.
The present study will include individuals with chronic kidney disease who are followed up by the Nephrology Outpatient Clinic of Dokuz Eylül University Research and Application Hospital and treated with peritoneal dialysis. The objective of the study is to examine the relationship between cardiovascular risk factors and physical activity parameters in chronic kidney disease patients treated with peritoneal dialysis. Patients who meet the specified criteria will be included in the study. A comprehensive collection of sociodemographic and clinical information will be conducted, followed by an evaluation of cardiovascular risk factors. Heart rate, blood pressure, waist circumference, body mass index, laboratory findings (lipid profile [total cholesterol level, LDL and HDL cholesterol, triglycerides], fasting glucose value, HbA1C value, hemoglobin, CRP, proteinuria, glomerular filtration rate (GFR)), smoking history, and risk percentage will be determined with the HeartScore scoring system. The IEM Mobil-O-Graph® device will be used for arterial stiffness measurement. The physical activity parameters will be evaluated using an accelerometer (Sensewear Armband device), and the relationship between them will be analyzed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease Patients Treated with Peritoneal Dialysis | – | –The study will examine cardiovascular risk factors and physical activity parameters in a sample of 23 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease who are followed up by the Nephrology Outpatient Clinic of Dokuz Eylül University Research and Application Hospital and treated with peritoneal dialysis will be included in the study.
Key inclusion criteria (3 listed)
- Diagnosed with chronic kidney disease
- Peritoneal dialysis treatment for at least three months
- Age ≥ 18
Key exclusion criteria (4 listed)
- Mini Mental Test Score < 24
- Serious cardiovascular, pulmonary, or neurological conditions that make it impossible to wear an accelerometer
- Inability to walk independently
- Conditions affecting participation in daily life due to lower limb injury or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Physical Activity Level
Time frame: Seven days
Physical activity is defined as any body movement that results in the body expending more energy than its basal level of energy expenditure, due to skeletal muscle contraction. The assessment of physical activity levels will be conducted using the SenseWear Armband (SWK). The SWK will be used to obtain several pieces of information, including the number of steps, total energy expenditure (in calories), average day and night sleep time (in minutes), average day and night reaching time (in minutes), average metabolic equivalent (MET), active energy expenditure (in calories) consumed during moderate (3 MET) physical activity, and physical activity duration (in minutes, 3 MET). Subjects will be requested to utilize the device for a period of seven consecutive days.
Arterial Stiffness Measurement
Time frame: 1 day
Arterial stiffness represents the viscoelastic properties of the vessel wall, indicates vascular damage, and is a measure of the degree of atherosclerosis. Increased arterial stiffness or decreased compliance indicates diffuse atherosclerotic involvement of the vasculature. One of the non-invasive techniques used to assess arterial stiffness is pulse wave analysis (PWA). PWA examines the pressure waveforms in the major arteries. Pulse wave velocity (PWV) and amplification index (Alx) are indices of arterial stiffness.PWV is the velocity of the pulse propagating along the arterial segment. Alx is the ratio of the difference between the late systolic pressure reflected from the periphery and the early systolic pressure to the pulse pressure and is expressed as a percentage. The IEM Mobil-O-Graph® device is used to assess arterial stiffness.
Assessment of Cardiovascular Risk Factors
Time frame: 1 day
The following health metrics will be evaluated using the HeartScore scoring system to determine risk percentage: heart rate, blood pressure, waist circumference, body mass index, lipid profile (total cholesterol level, LDL and HDL cholesterol, triglycerides), fasting glucose value, HbA1C value, hemoglobin, CRP, proteinuria, smoking history, and glomerular filtration rate (GFR).The HeartScore system is a web-based risk prediction and management program that aims to support clinicians in optimizing individual cardiovascular risk reduction. The HeartScore web-based program utilizes a sophisticated algorithm to calculate the 10-year cardiovascular mortality risk based on age, gender, smoking habits, blood pressure, blood cholesterol, and the total cholesterol/HDL ratio. The European (High and Low) and National versions are currently available. However, the program is designed by national cardiology associations to be adapted to the local conditions of the countries.
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 27 Jun 2025.
- Individual participant dataSharing planned: No. The reason for not sharing data is the concern about unauthorized use.
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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.
Faculty of Physical Therapy and Rehabilitation Dokuz Eylul University contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Cardiovascular Risk Factors, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 4 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: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 Ayten Demir, Graduate Student (+90 232 277 50 30, aytenersoz35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Physical Activity Level (time frame: Seven days). The study lists 3 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 27 Jun 2025.