The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients

NCT06697418 | Enrolling By Invitation

• 1 other identifier: PACOPD
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore how daily physical activity (PA) levels affect the heart health and cognitive function of patients on peritoneal dialysis (PD). Using a fitness tracker, the investigators will measure how much patients move during the day and see if lower activity levels are linked to a higher risk of heart disease or memory issues. The study has two parts: Part A: The investigators will evaluate 266 patients to understand their current PA levels and how these relate to heart health and cognitive function. Part B: The investigators will follow the same patients over a year, measuring their activity at the beginning and after 12 months. The investigators will divide them into two groups-those who increase their PA and those whose PA decreases-and follow their heart health and memory function over two years. The goal is to understand whether higher PA levels can reduce the risk of heart problems and memory issues in PD patients.

Conditions

Peritoneal Dialysis; Cardiovascular Diseases; Myocardial Infarct; Heart Failure; Cognitive Disorders

Keywords

peritoneal dialysis; physical activities; wristband; cardiovascular risk; cognition

Outcome Measures

Primary Outcomes (1)

• Number of participants with Composite Endpoints of Cardiovascular Events

  The composite endpoint of cardiovascular events includes cardiovascular death, non-fatal myocardial infarction, heart failure, stroke, valve replacement surgery, and coronary artery bypass surgery. Planning to establish a terminal endpoint assessment group to review the medical records of each patient, with two physicians independently assessing the endpoints for each case.

  through study completion, an average of 3 months

Secondary Outcomes (12)

• Change from baseline in levels of high-sensitivity cardiac troponin I in 2 years

  Baseline and the 12th, 24th month after entering the cohort

• Change from baseline in levels of myoglobin in 2 years

  Baseline and the 12th, 24th month after entering the cohort

• Change from baseline in levels of Creatine Kinase-MB (CK-MB) in 2 years

  Baseline and the 12th, 24th month after entering the cohort

• Change from baseline in levels of Creatine Kinase (CK) in 2 years

  Baseline and the 12th, 24th month after entering the cohort

• Change from baseline in levels of parameters from echocardiogram in 2 years

  Baseline and the 12th, 24th month after entering the cohort

Study Arms (2)

Active Group

The average daily physical activity measured by the fitness tracker is above 5,000 steps.

Sedentary Group

The average daily physical activity measured by the fitness tracker is below 5,000 steps.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Receiving peritoneal dialysis treatment in Ruijin hospital for more than three months

You may qualify if:

• years old or above, under 75 years old
• Receiving peritoneal dialysis treatment in Ruijin hospital for more than three months
• Having the ability to walk independently
• Willing to accept relevant training and sign informed consent

You may not qualify if:

• Unable or unwilling to provide written informed consent;
• Unwilling to cooperate with regular follow-up or telephone follow-up;
• Evidence of liver damage (ALT, AST≥ 2 times the upper limit of normal);
• Patients with newly diagnosed malignant tumors in the past year or undergoing radiotherapy or chemotherapy;
• NYHA class III or IV congestive heart failure, myocardial infarction, stable or unstable angina;
• New-onset stroke (within the past 3 months, including cerebral hemorrhage and cerebral infarction);
• Severe mental illness or a diagnosis of dementia.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital - Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 2000245, China

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Myocardial Infarction; Heart Failure; Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 20, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)