Cardiovascular Risk Factors and Physical Activity in Chronic Kidney Patients on Peritoneal Dialysis

NCT07041554 | Not Yet Recruiting

• 1 other identifier: DEU-FTR-AE-02
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Cardiovascular Risk Factors; Arterial Stiffness; Physical Activity

Keywords

cardiovascular risk factors; physical activity; arterial stiffness; accelerometer; peritoneal dialysis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 day

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Diagnosed with chronic kidney disease
• Peritoneal dialysis treatment for at least three months
• Age ≥ 18

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University Faculty of Physical Therapy and Rehabilitation

Izmir, 35410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Ayten Demir, Graduate Student

CONTACT

+90 232 277 50 30; aytenersoz35@gmail.com

Faculty of Physical Therapy and Rehabilitation Dokuz Eylul University

CONTACT

+90 232 277 50 30; fiziktedavi@deu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: June 23, 2025
• Primary Completion: September 2, 2025
• Study Completion: December 31, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)