Clinical trial NCT06697418: The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients
Official title: The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Peritoneal Dialysis
Cardiovascular Diseases
Myocardial Infarct
Heart Failure
Cognitive Disorders
Keywords: peritoneal dialysis
physical activities
wristband
cardiovascular risk
cognition
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Receiving peritoneal dialysis treatment in Ruijin hospital for more than three months

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.

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.

Primary outcomes:
measure: Number of participants with Composite Endpoints of Cardiovascular Events
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Change from baseline in levels of high-sensitivity cardiac troponin I in 2 years
timeFrame: Baseline and the 12th, 24th month after entering the cohort
measure: Change from baseline in levels of myoglobin in 2 years
timeFrame: Baseline and the 12th, 24th month after entering the cohort
measure: Change from baseline in levels of Creatine Kinase-MB (CK-MB) in 2 years
timeFrame: Baseline and the 12th, 24th month after entering the cohort
measure: Change from baseline in levels of Creatine Kinase (CK) in 2 years
timeFrame: Baseline and the 12th, 24th month after entering the cohort
measure: Change from baseline in levels of parameters from echocardiogram in 2 years
timeFrame: Baseline and the 12th, 24th month after entering the cohort
measure: Change from baseline in levels of Mini-Mental State Examination(MMSE) in 2 years
timeFrame: Baseline and the 12th, 24th month after entering the cohort
measure: Change from baseline in levels of Montreal Cognitive Assessment (MoCA) in 2 years
timeFrame: Baseline and the 12th, 24th month after entering the cohort
measure: Change from baseline in levels of Auditory Verbal Learning Test-H (AVLT-H) in 2 years
timeFrame: Baseline and the 12th, 24th month after entering the cohort
measure: Change from baseline in levels of Trail Making Test-B (TMT-B) in 2 years
timeFrame: Baseline and the 12th, 24th month after entering the cohort
measure: Baseline levels of total and phosphorylated Tau
timeFrame: Baseline
measure: Baseline plasma levels of Neurofilament Light Chain (NfL)
timeFrame: Baseline
measure: Baseline plasma levels of Glial Fibrillary Acidic Protein (GFAP)
timeFrame: Baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital - Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: