Peritoneal DialysisNCT06697418
The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients
An observational study of Peritoneal Dialysis and Cardiovascular Diseases, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Dialysis, Cardiovascular Diseases, Myocardial Infarct
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Oct 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Receiving peritoneal dialysis treatment in Ruijin hospital for more than three months
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital - Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 2000245
About this study
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:
Read more
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.
Read the 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
- Keywords
- peritoneal dialysis, physical activities, wristband, cardiovascular risk, cognition
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Heart Failure, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Cardiac Troponin I (cTnI) is a highly specific biomarker used to assess myocardial injury. It is a subunit of the troponin complex that regulates cardiac muscle contraction. cTnI is uniquely expressed in cardiac muscle and is released into the bloodstream during myocardial cell damage, making it a critical indicator of myocardial injury. Levels of high-sensitivity cardiac troponin I will be evaluated in ug/L.
Measured: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of myoglobin in 2 years
A heme-containing protein found in cardiac and skeletal muscle, released very early during muscle injury. Levels of myoglobin will be evaluated in ug/L.
Measured: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Creatine Kinase-MB (CK-MB) in 2 years
A cardiac-specific isoenzyme of CK, more specific to myocardial tissue than total CK. Levels of CK-MB will be evaluated in ug/L.
Measured: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Creatine Kinase (CK) in 2 years
An enzyme found in various tissues, including skeletal and cardiac muscles. It catalyzes ATP production during muscle contraction. Levels of CK will be evaluated in ug/L.
Measured: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of parameters from echocardiogram in 2 years
Parameters from echocardiogram will be collected including posterior wall thickness in millimeter, septal thickness in millimeter, Left Ventricle Length in millimeter, Left Atrium length in millimeter, Left Ventricle Mass in gram, left ventricular diastolic volume in milliliter, left ventricular systolic volume in milliliter, left ventricular ejection fraction in percent, ejection volume in milliliter and E/A ratio.
Measured: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Mini-Mental State Examination(MMSE) in 2 years
The Mini-Mental State Examination (MMSE) is a widely used tool for assessing cognitive function. It is commonly employed in clinical and research settings to screen for cognitive impairment, monitor cognitive changes over time, and assess the severity of cognitive dysfunction.The MMSE has a minimum score of 0 and a maximum score of 30. Higher scores indicate better cognitive function, while lower scores suggest greater cognitive impairment.
General guidelines for interpreting MMSE scores are:
- 24-30: No cognitive impairment
- 18-23: Mild cognitive impairment
- 0-17: Severe cognitive impairment
Measured: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Montreal Cognitive Assessment (MoCA) in 2 years
The MoCA is a screening tool for detecting mild cognitive impairment (MCI) and early dementia.The MoCA has a maximum score of 30. A score of 26 or higher generally indicates normal cognitive function.Scores below 26 suggest varying degrees of cognitive impairment, though age, education, and cultural differences can affect interpretation. Higher scores reflect better cognitive performance. Lower scores indicate greater cognitive impairment.
Measured: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Auditory Verbal Learning Test-H (AVLT-H) in 2 years
The AVLT-H is used to evaluate verbal memory, learning, and recall. It is a variant of the traditional AVLT adapted for specific populations. It assesses immediate recall, delayed recall, and recognition memory through a list-learning paradigm.The total score depends on the number of correct responses during the recall and recognition phases. Higher scores indicate better memory performance and learning ability.
Measured: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Trail Making Test-B (TMT-B) in 2 years
TMT-B measures executive function, specifically cognitive flexibility, attention, and task-switching ability.The score is the time taken (in seconds) to complete the task. Errors must be corrected, which can increase the time. Lower scores (shorter completion time) indicate better executive function. Higher scores (longer completion time) suggest poorer cognitive flexibility or attention.
Measured: Baseline and the 12th, 24th month after entering the cohort
Baseline levels of total and phosphorylated Tau
Tau is the marker of neuronal injury and tauopathy. Lower levels are generally not diagnostic but may indicate absence of disease.Total Tau (t-Tau): Reflects overall neuronal injury. Phosphorylated Tau (p-Tau): Specifically associated with Alzheimer's disease pathology.
Measured: Baseline
Baseline plasma levels of Neurofilament Light Chain (NfL)
Non-specific marker of axonal damage, elevated in numerous neurological diseases, including multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Alzheimer's, and traumatic brain injury.
Measured: Baseline
Baseline plasma levels of Glial Fibrillary Acidic Protein (GFAP)
Marker of reactive astrocytosis, a process where astrocytes become activated in response to brain injury or disease. Elevated in conditions with neuroinflammation, such as MS, traumatic brain injury, and Alzheimer's.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2024
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Jingyuan, MD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697418
- Sponsor's protocol ID
- PACOPD
- Status last verified
- Nov 2024
- First submitted
- 15 Oct 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to concerns regarding patient privacy and hospital policy restrictions, there are currently no plans to make individual participant data (IPD) publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT06697418
- Acronym / sponsor ID
- PACOPD
- Conditions
- Peritoneal Dialysis, Cardiovascular Diseases, Myocardial Infarct, Heart Failure, Cognitive Disorders
- Keywords
- peritoneal dialysis, physical activities, wristband, cardiovascular risk, cognition
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Receiving peritoneal dialysis treatment in Ruijin hospital for more than three months
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with Composite Endpoints of Cardiovascular Events
Time frame: through study completion, an average of 3 months
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.
12 secondary outcomes
Change from baseline in levels of high-sensitivity cardiac troponin I in 2 years
Time frame: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of myoglobin in 2 years
Time frame: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Creatine Kinase-MB (CK-MB) in 2 years
Time frame: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Creatine Kinase (CK) in 2 years
Time frame: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of parameters from echocardiogram in 2 years
Time frame: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Mini-Mental State Examination(MMSE) in 2 years
Time frame: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Montreal Cognitive Assessment (MoCA) in 2 years
Time frame: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Auditory Verbal Learning Test-H (AVLT-H) in 2 years
Time frame: Baseline and the 12th, 24th month after entering the cohort
Change from baseline in levels of Trail Making Test-B (TMT-B) in 2 years
Time frame: Baseline and the 12th, 24th month after entering the cohort
Baseline levels of total and phosphorylated Tau
Time frame: Baseline
Baseline plasma levels of Neurofilament Light Chain (NfL)
Time frame: Baseline
Baseline plasma levels of Glial Fibrillary Acidic Protein (GFAP)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No. Due to concerns regarding patient privacy and hospital policy restrictions, there are currently no plans to make individual participant data (IPD) publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis and Cardiovascular Diseases, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Composite Endpoints of Cardiovascular Events (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.