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

NCT07131488 | Not Yet Recruiting

• 1 other identifier: 20250731
• Study Type: observational
• Target: 614
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular-kidney-metabolic Syndrome

Keywords

Time-limited Self-regulation Theory; physical activity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline , 3 months, 6 months, 9 months

Secondary Outcomes (8)

• Monetary Choice Questionnaire (MCQ)

  Baseline , 3 months, 6 months, 9 months

• Exercise Benefits/Barriers Scale (EBBS)

  Baseline , 3 months, 6 months, 9 months

• Intentions

  Baseline , 3 months, 6 months, 9 months

• Self-Report Habit Index (SRHI)

  Baseline , 3 months, 6 months, 9 months

• Healthy Neighborhood Survey for Community-Dwelling Older Adults

  Baseline , 3 months, 6 months, 9 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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)
• 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).

Sponsors & Collaborators

• Nanjing Medical University: lead

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Zhongmin Fu

CONTACT

86-15120179663; 15120179663@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 20, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share