NCT07131488

Mechanisms and Interventions for Physical Activity in Frail Cardiovascular-kidney-metabolic Syndrome Patients: A Temporal Self-Regulation Approach

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 614 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2025-08-20
• Primary completion: 2026-10-12
• Completion: 2026-10-12
• First posted: 2025-08-20
• Last updated: 2025-08-20