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

NCT ID: NCT06697418

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 266 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-10-31

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.

Detailed Description

Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney disease (CKD), and cognitive impairment is also common in CKD patients. Previous studies have suggested an association between physical activity (PA) levels, CVD, and mild cognitive impairment. However, no relevant studies have been conducted in peritoneal dialysis (PD) patients, who are at high risk for both CVD and cognitive impairment. This study aims to measure the daily PA levels of PD patients using a wristband and analyze its impact on CVD and cognitive function in these patients.

The study consists of two parts:

Part A: A cross-sectional study, planning to enroll 266 patients. Demographic and baseline clinical data will be recorded, and PA will be assessed using the wrist-wearable devices. CVD will be evaluated using cardiac enzyme levels, N-terminal pro-B-type natriuretic peptide (NTpro-BNP), and echocardiography (UCG) parameters, while cognitive function will be assessed with the MMSE, MOCA and other scales. A multivariate logistic regression model will be used to analyze the correlation between PA and the prevalence of CVD and cognitive impairment.

Part B: A prospective cohort study. The enrolled patients will undergo repeated PA assessments using the wristband at months 0 and 12. Based on changes in PA from baseline, patients will be divided into an increased PA group and a decreased PA group. Both groups will be followed up to record major cardiovascular events and assess changes in left ventricular function and structure using cardiac enzyme levels, NTpro-BNP, and UCG indicators. Cognitive function will be evaluated using the MMSE, MOCA and other scales at months 0, 12, and 24 to assess changes in cognitive levels.

Expected Results: PA levels are expected to be associated with CVD and cognitive impairment in PD patients, with lower PA levels or decreased PA predicting a higher risk of new-onset CVD and cognitive impairment.

Primary Hypothesis: Lower PA levels are associated with increased CVD risk in PD patients, while higher PA levels or improvements in PA are associated with a lower risk of new-onset CVD.

Secondary Hypothesis: Lower PA levels are associated with increased cognitive impairment in PD patients, while higher PA levels or improvements in PA are associated with a lower risk of new-onset cognitive impairment.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active Group

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

No interventions assigned to this group

Sedentary Group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. 18 years old or above, under 75 years old

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

3. Having the ability to walk independently

4. Willing to accept relevant training and sign informed consent

Exclusion Criteria

1. Unable or unwilling to provide written informed consent;

2. Unwilling to cooperate with regular follow-up or telephone follow-up;

3. Evidence of liver damage (ALT, AST≥ 2 times the upper limit of normal);

4. Patients with newly diagnosed malignant tumors in the past year or undergoing radiotherapy or chemotherapy;

5. NYHA class III or IV congestive heart failure, myocardial infarction, stable or unstable angina;

6. New-onset stroke (within the past 3 months, including cerebral hemorrhage and cerebral infarction);

7. Severe mental illness or a diagnosis of dementia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xie Jingyuan, MD

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital - Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

PACOPD

Identifier Type: -

Identifier Source: org_study_id