Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT06697418
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-11-20
First Post:
2024-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients
Sponsor:
Ruijin Hospital
Organization:
Study Overview
Official Title:
The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: