Cardiovascular-kidney-metabolic SyndromeCKMNCT07131488
Mechanisms and Interventions for Physical Activity in Frail Cardiovascular-kidney-metabolic Syndrome Patients: A Temporal Self-Regulation Approach
An observational study of Cardiovascular-kidney-metabolic Syndrome, run by Nanjing Medical University.
Trial summary
Longitudinal physical activity data and associated factors were collected at baseline (diagnosis), 3-month, 6-month, and 9-month follow-ups in cardiovascular-kidney-metabolic syndrome patients. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Cardiovascular-kidney-metabolic Syndrome
- How many people
- 614 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 12 Oct 2026
- How long will I take part?
- 9 Months
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study was conducted at the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), enrolling 614 middle-aged adults with frailty and cardiovascular-kidney-metabolic (CKM) syndrome. Participants who met the inclusion/exclusion criteria and provided written informed consent were prospectively followed for 12 months.
Who may be able to join
- Aged ≥45 years and <60 years;
- Frailty status assessed by Fried phenotype criteria, including those diagnosed with frailty or pre-frailty;
- Meeting AHA guideline criteria for Stage 1-2 CKM syndrome (diagnostic details in Table 1);
- Ability to communicate normally and use smartphones or wearable devices;
- Willingness to participate in surveys and follow-up;
- Additional Note on PREVENT Equation:
Show all 13Show fewer
- The PREVENT equation, developed by the American Heart Association (AHA), is a cardiovascular disease (CVD) risk prediction tool. It calculates 10-year CVD risk based on:
- Age, sex
- Total cholesterol, HDL-C
- Systolic blood pressure, BMI
- eGFR
- History of diabetes, smoking
- Use of antihypertensive or lipid-lowering medications
Who cannot join
- Severe cognitive impairment (e.g., MMSE score <10 or clinical dementia diagnosis);
- Severe psychiatric/psychological disorders (e.g., schizophrenia, major depressive disorder with suicidal ideation);
- Advanced chronic diseases including:
- End-stage renal disease (eGFR <15 mL/min/1.73m² or on dialysis)
- Metastatic cancer (stage IV per AJCC criteria)
- Cardiorespiratory insufficiency (NYHA Class III-IV heart failure or COPD GOLD Stage D)
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- Severe osteoarthritis (Kellgren-Lawrence Grade 4 with functional limitation)
- Major surgery or acute illness within 3 months (e.g., myocardial infarction, stroke, or major trauma requiring hospitalization);
- Physical disabilities impairing mobility (e.g., amputation, paralysis, or severe Parkinsonism with Hoehn \& Yahr Stage ≥3).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Research on the Mechanisms and Intervention Strategies for Physical Activity Promotion in Frail Patients With Cardiovascular-Kidney-Metabolic Syndrome From a Temporal Self-Regulation Perspective
Longitudinal physical activity data and associated factors were collected at baseline (diagnosis), 3-month, 6-month, and 9-month follow-ups in cardiovascular-kidney-metabolic syndrome patients.
Read the detailed description
This study targets the frail population with early-middle-age CKM syndrome. Grounded in the Time-limited Self-regulation Theory (TST), it employs behavioral data analysis, theoretical variable modeling, and intervention strategy development to systematically identify risk trajectories and influencing pathways of physical activity (PA) insufficiency, thereby formulating stratified and classified intervention strategies to enhance PA levels. The research comprises three key components:
Research Component 1: Risk Prediction Model for PA Insufficiency in Frail CKM Syndrome Patients Early-middle-age frail CKM syndrome patients exhibit significant PA insufficiency and behavioral variability at the disease onset. Early identification of PA evolution trends and high-risk groups is crucial for timely intervention and precise resource allocation.
Objective:
To determine "who is more likely to sustain PA insufficiency" by constructing a trajectory identification model and risk prediction tool using longitudinal data, analyzing dynamic PA behavior patterns, and quantifying multifactorial risk probabilities to support subsequent intervention mechanisms and strategy classification.
Study Design:
Exploring PA Trajectories in Frail CKM Syndrome Patients
Target Population: Early-middle-age frail CKM patients (aligned with AHA lifestyle management guidelines).
Method: Prospective longitudinal study with multi-timepoint data collection.
Analysis: Group-based trajectory modeling (GBTM) to delineate PA dynamics, identifying high-risk trends (e.g., persistent insufficiency, steep decline).
Developing a Risk Prediction Model for PA Insufficiency
Dependent Variable: PA trajectory classification (e.g., stable-high, persistent-low, fluctuating).
Predictors: Sociodemographics, health behaviors, and environmental factors.
Method: Multi-class machine learning (XGBoost) to identify key predictors and quantify risk probabilities.
Output: Interactive visualization tool for community-level screening of high-risk individuals.
Research Component 2: TST-Based Mechanisms of PA Promotion in Frail CKM Syndrome Patients
To elucidate the key determinants and moderators of PA insufficiency, this study leverages TST's six core variables:
Behavioral intention
Consistency beliefs
Self-control capacity
Delay discounting tendency
Environmental cue perception
Habit formation strength
Methodological Approach:
Dynamic Feature Engineering:
Multi-timepoint measurement of TST variables → Derived metrics (baseline level, trend, mean, variability).
Dimensionality Reduction:
LASSO regression + PCA to mitigate multicollinearity.
Predictive Modeling:
XGBoost classification (trajectory groups as outcomes) + SHAP analysis to rank variable contributions.
Causal Pathway Analysis:
Generalized structural equation modeling (GSEM) to identify mechanistic pathways.
Outcome:
Prioritized modifiable factors (e.g., self-control > environmental cues) for tailored interventions.
Research Component 3: TST-Driven PA Promotion Strategies for Frail CKM Syndrome Patients Goal: Translate mechanistic insights into actionable, precision strategies for behavior change.
Strategy Development Framework:
Intervention Targets:
Mechanistic variables (e.g., enhancing self-control in "persistent-low" trajectory patients).
Three Strategy Archetypes:
Intrinsic Motivation Modulation (e.g., goal-setting interventions)
Social Support Activation (e.g., peer coaching)
Environmental Cue Optimization (e.g., neighborhood walkability enhancements)
Strategy Prioritization:
Analytic Hierarchy Process (AHP) to weight strategies by feasibility, acceptability, and efficacy.
Deliverable:
A modular "PA Promotion Toolkit" for phased, adaptive community interventions.
- Conditions
- Cardiovascular-kidney-metabolic Syndrome
- Keywords
- Time-limited Self-regulation Theory, physical activity
- Medical subject headings
- 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 |
|---|---|---|
| Middle-aged frail population with CKM syndrome | This was a non-interventional longitudinal study，primarily focuses on the mechanisms and factors influencing physical activity in middle-aged CKM syndrome patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consideration of Future Consequences Scale (CFC-S)
The Consideration of Future Consequences Scale (CFC-S), developed by Strathman et al., includes two dimensions: consideration of the present (items 3, 4, 5, 9, 10, 11, 12) and consideration of the future (items 1, 2, 6, 7, 8). The Chinese version was cross-culturally adapted by Feng Jiaxi et al. The scale includes 12 items, rated on a 7-point Likert scale, where 1 means "not at all like me" and 7 means "exactly like me." Internal consistency coefficients in elderly populations are 0.71 and 0.80 for the two dimensions, and split-half reliability is 0.69 and 0.78, indicating good psychometric properties.
Measured: Baseline , 3 months, 6 months, 9 months
Global Physical Activity Questionnaire (GPAQ)
It includes four domains: work, transportation, recreation, and sedentary behavior. The questionnaire assesses the participant's PA in these four areas over the course of a week. PA in the work and recreation domains is further classified into vigorous and moderate levels. The questionnaire contains 16 items, and only activities lasting more than 10 minutes are considered relevant PA.The higher the activity intensity, the greater the MET value, meaning the body consumes more energy. High PA Level: At least three days of vigorous-intensity activity per week, with a total MET value of at least 1500 METs, or daily moderate-to-vigorous activity with a total MET value of at least 3000 METs per week.
Moderate PA Level: At least three days of vigorous-intensity activity per week.Low PA Level: Insufficient activity, where the individual does not meet the moderate-to-vigorous intensity activity standard.
Measured: Baseline , 3 months, 6 months, 9 months
Secondary outcomes (8)
Monetary Choice Questionnaire (MCQ)
he Monetary Choice Questionnaire (MCQ), developed by Kirby et al., is a widely validated tool to assess delay discounting. An Excel-based tool for automatic calculation of discount rates is available for free.
Measured: Baseline , 3 months, 6 months, 9 months
Exercise Benefits/Barriers Scale (EBBS)
The Exercise Benefits/Barriers Scale (EBBS) measures perceived exercise benefits and barriers in CKM syndrome patients. Higher scores indicate greater perception of exercise benefits and fewer barriers.
Measured: Baseline , 3 months, 6 months, 9 months
Intentions
Participants are informed of the recommended weekly PA levels: 150 minutes of moderate-intensity aerobic exercise or 75 minutes of vigorous-intensity aerobic exercise, plus at least two days of muscle-strengthening exercises. Physical activity intentions will be measured using a subscale from the TPB questionnaire, developed and validated by Ajzen (1991) and adapted for China by Hu et al. (2008). Intention is assessed using three items on a scale from 1 (strongly disagree) to 6 (strongly agree). Higher average scores indicate stronger intentions. This subscale has excellent reliability, with a Cronbach's α of 0.944.
Measured: Baseline , 3 months, 6 months, 9 months
Self-Report Habit Index (SRHI)
The Self-Report Habit Index (SRHI), a commonly used measure of habits, consists of 12 items covering three dimensions: behavioral repetition history, lack of awareness, and lack of control. The behavior X (defined as moderate-to-vigorous physical activity in this study) is assessed by participants through these 12 items. A 5-point Likert scale is used in the Chinese version, which has a Cronbach's α of 0.961.
Measured: Baseline , 3 months, 6 months, 9 months
Healthy Neighborhood Survey for Community-Dwelling Older Adults
The community leisure environment is assessed in terms of 10 aspects: interesting architecture, clean and tidy surroundings, attractive environment, easy walkability, suitability for walking, abundant trees, availability of exercise opportunities, sufficient exercise facilities, ability to attract residents to walk, and ability to encourage residents to exercise. The scale ranges from 1 to 5, with options for "Strongly Disagree," "Disagree," "Neutral," "Agree," and "Strongly Agree," reflecting the respondent's recognition of various aspects of the community leisure environment.
Measured: Baseline , 3 months, 6 months, 9 months
Brief Self-Control Scale (BSCS)
Self-control, an important aspect of self-regulation, will be measured using the Brief Self-Control Scale (BSCS), originally developed by Morean et al. The scale consists of 7 items measuring two dimensions: self-discipline (items 1, 3, 5) and impulse control (items 2, 4, 6, 7). Higher scores indicate better self-regulation. The Chinese version of the BSCS has a Cronbach's α of 0.83.
Measured: Baseline , 3 months, 6 months, 9 months
Multidimensional Frailty
Multidimensional frailty is assessed based on the Frailty Integration Model and the Tilburg Frailty Indicator. The indicators include physical frailty, psychological frailty, and social frailty. Frailty is measured by calculating a total frailty score, with a maximum score of 15 points. A score of ≥5 indicates multidimensional frailty, with higher scores indicating greater severity of frailty.
Physical Frailty: The maximum score is 8 points, with ≥3 points indicating physical frailty.
Psychological Frailty: The maximum score is 4 points, with ≥1.5 points indicating psychological frailty.
Social Frailty: The maximum score is 3 points, with ≥1.5 points indicating social frailty
Measured: baseline
Charlson Comorbidity Index (CCI)
The CCI evaluates comorbidities and disease severity, with a higher score indicating greater comorbidity. Different diseases have different weightings, and the index has been updated to include 23 diseases, including hypertension, depression, and the use of anticoagulants. The higher the score, the more severe the comorbidities.
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 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion12 Oct 2026 (estimated)
- Study completion12 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular-kidney-metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 614 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongmin Fu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131488
- Sponsor's protocol ID
- 20250731
- Acronym
- CKM
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Mechanisms and Intervention Strategies for Physical Activity Promotion in Frail Patients With Cardiovascular-Kidney-Metabolic Syndrome From a Temporal Self-Regulation Perspective
- ClinicalTrials.gov ID
- NCT07131488
- Acronym / sponsor ID
- CKM / 20250731
- Conditions
- Cardiovascular-kidney-metabolic Syndrome
- Keywords
- Time-limited Self-regulation Theory, physical activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 614 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 12 Oct 2026 (estimated)
- Study completion
- 12 Oct 2026 (estimated)
- First posted
- 20 Aug 2025 (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.
Longitudinal physical activity data and associated factors were collected at baseline (diagnosis), 3-month, 6-month, and 9-month follow-ups in cardiovascular-kidney-metabolic syndrome patients.
Detailed description
This study targets the frail population with early-middle-age CKM syndrome. Grounded in the Time-limited Self-regulation Theory (TST), it employs behavioral data analysis, theoretical variable modeling, and intervention strategy development to systematically identify risk trajectories and influencing pathways of physical activity (PA) insufficiency, thereby formulating stratified and classified intervention strategies to enhance PA levels. The research comprises three key components:
Research Component 1: Risk Prediction Model for PA Insufficiency in Frail CKM Syndrome Patients Early-middle-age frail CKM syndrome patients exhibit significant PA insufficiency and behavioral variability at the disease onset. Early identification of PA evolution trends and high-risk groups is crucial for timely intervention and precise resource allocation.
Objective:
To determine "who is more likely to sustain PA insufficiency" by constructing a trajectory identification model and risk prediction tool using longitudinal data, analyzing dynamic PA behavior patterns, and quantifying multifactorial risk probabilities to support subsequent intervention mechanisms and strategy classification.
Study Design:
Exploring PA Trajectories in Frail CKM Syndrome Patients
Target Population: Early-middle-age frail CKM patients (aligned with AHA lifestyle management guidelines).
Method: Prospective longitudinal study with multi-timepoint data collection.
Analysis: Group-based trajectory modeling (GBTM) to delineate PA dynamics, identifying high-risk trends (e.g., persistent insufficiency, steep decline).
Developing a Risk Prediction Model for PA Insufficiency
Dependent Variable: PA trajectory classification (e.g., stable-high, persistent-low, fluctuating).
Predictors: Sociodemographics, health behaviors, and environmental factors.
Method: Multi-class machine learning (XGBoost) to identify key predictors and quantify risk probabilities.
Output: Interactive visualization tool for community-level screening of high-risk individuals.
Research Component 2: TST-Based Mechanisms of PA Promotion in Frail CKM Syndrome Patients
To elucidate the key determinants and moderators of PA insufficiency, this study leverages TST's six core variables:
Behavioral intention
Consistency beliefs
Self-control capacity
Delay discounting tendency
Environmental cue perception
Habit formation strength
Methodological Approach:
Dynamic Feature Engineering:
Multi-timepoint measurement of TST variables → Derived metrics (baseline level, trend, mean, variability).
Dimensionality Reduction:
LASSO regression + PCA to mitigate multicollinearity.
Predictive Modeling:
XGBoost classification (trajectory groups as outcomes) + SHAP analysis to rank variable contributions.
Causal Pathway Analysis:
Generalized structural equation modeling (GSEM) to identify mechanistic pathways.
Outcome:
Prioritized modifiable factors (e.g., self-control > environmental cues) for tailored interventions.
Research Component 3: TST-Driven PA Promotion Strategies for Frail CKM Syndrome Patients Goal: Translate mechanistic insights into actionable, precision strategies for behavior change.
Strategy Development Framework:
Intervention Targets:
Mechanistic variables (e.g., enhancing self-control in "persistent-low" trajectory patients).
Three Strategy Archetypes:
Intrinsic Motivation Modulation (e.g., goal-setting interventions)
Social Support Activation (e.g., peer coaching)
Environmental Cue Optimization (e.g., neighborhood walkability enhancements)
Strategy Prioritization:
Analytic Hierarchy Process (AHP) to weight strategies by feasibility, acceptability, and efficacy.
Deliverable:
A modular "PA Promotion Toolkit" for phased, adaptive community interventions.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle-aged frail population with CKM syndrome | – | –This was a non-interventional longitudinal study，primarily focuses on the mechanisms and factors influencing physical activity in middle-aged CKM syndrome patients. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study was conducted at the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), enrolling 614 middle-aged adults with frailty and cardiovascular-kidney-metabolic (CKM) syndrome. Participants who met the inclusion/exclusion criteria and provided written informed consent were prospectively followed for 12 months.
Key inclusion criteria (13 listed)
- Aged ≥45 years and <60 years;
- Frailty status assessed by Fried phenotype criteria, including those diagnosed with frailty or pre-frailty;
- Meeting AHA guideline criteria for Stage 1-2 CKM syndrome (diagnostic details in Table 1);
- Ability to communicate normally and use smartphones or wearable devices;
- Willingness to participate in surveys and follow-up;
Key exclusion criteria (9 listed)
- Severe cognitive impairment (e.g., MMSE score <10 or clinical dementia diagnosis);
- Severe psychiatric/psychological disorders (e.g., schizophrenia, major depressive disorder with suicidal ideation);
- End-stage renal disease (eGFR <15 mL/min/1.73m² or on dialysis)
- Metastatic cancer (stage IV per AJCC criteria)
- Cardiorespiratory insufficiency (NYHA Class III-IV heart failure or COPD GOLD Stage D)
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
Consideration of Future Consequences Scale (CFC-S)
Time frame: Baseline , 3 months, 6 months, 9 months
The Consideration of Future Consequences Scale (CFC-S), developed by Strathman et al., includes two dimensions: consideration of the present (items 3, 4, 5, 9, 10, 11, 12) and consideration of the future (items 1, 2, 6, 7, 8). The Chinese version was cross-culturally adapted by Feng Jiaxi et al. The scale includes 12 items, rated on a 7-point Likert scale, where 1 means "not at all like me" and 7 means "exactly like me." Internal consistency coefficients in elderly populations are 0.71 and 0.80 for the two dimensions, and split-half reliability is 0.69 and 0.78, indicating good psychometric properties.
Global Physical Activity Questionnaire (GPAQ)
Time frame: Baseline , 3 months, 6 months, 9 months
It includes four domains: work, transportation, recreation, and sedentary behavior. The questionnaire assesses the participant's PA in these four areas over the course of a week. PA in the work and recreation domains is further classified into vigorous and moderate levels. The questionnaire contains 16 items, and only activities lasting more than 10 minutes are considered relevant PA.The higher the activity intensity, the greater the MET value, meaning the body consumes more energy. High PA Level: At least three days of vigorous-intensity activity per week, with a total MET value of at least 1500 METs, or daily moderate-to-vigorous activity with a total MET value of at least 3000 METs per week. Moderate PA Level: At least three days of vigorous-intensity activity per week.Low PA Level: Insufficient activity, where the individual does not meet the moderate-to-vigorous intensity activity standard.
8 secondary outcomes
Monetary Choice Questionnaire (MCQ)
Time frame: Baseline , 3 months, 6 months, 9 months
Exercise Benefits/Barriers Scale (EBBS)
Time frame: Baseline , 3 months, 6 months, 9 months
Intentions
Time frame: Baseline , 3 months, 6 months, 9 months
Self-Report Habit Index (SRHI)
Time frame: Baseline , 3 months, 6 months, 9 months
Healthy Neighborhood Survey for Community-Dwelling Older Adults
Time frame: Baseline , 3 months, 6 months, 9 months
Brief Self-Control Scale (BSCS)
Time frame: Baseline , 3 months, 6 months, 9 months
Multidimensional Frailty
Time frame: baseline
Charlson Comorbidity Index (CCI)
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 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular-kidney-metabolic Syndrome, run by Nanjing Medical University.
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 13 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zhongmin Fu (86-15120179663, 15120179663@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consideration of Future Consequences Scale (CFC-S) (time frame: Baseline , 3 months, 6 months, 9 months). The study lists 2 primary outcomes in all. 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 Aug 2025.