The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disea… (NCT06697418) | Clinical Trial Compass
By InvitationNot Applicable
The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients
China266 participantsStarted 2024-10-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 18 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
Exclusion criteria
✕. 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);
What they're measuring
1
Number of participants with Composite Endpoints of Cardiovascular Events
Timeframe: through study completion, an average of 3 months