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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-60
SponsorNanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥45 years and <60 years;

Disqualifiers

Severe cognitive impairment (e.g., MMSE score <10 or clinical dementia diagnosis);

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

614 Participants
are grouped into 1 trial group
Group A: Middle-aged frail population with CKM syndrome

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline , 3 months, 6 months, 9 months
2

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.

Time frame
Baseline , 3 months, 6 months, 9 months

Secondary outcomes

1

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.

Time frame
Baseline , 3 months, 6 months, 9 months
2

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.

Time frame
Baseline , 3 months, 6 months, 9 months
3

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.

Time frame
Baseline , 3 months, 6 months, 9 months
4

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.

Time frame
Baseline , 3 months, 6 months, 9 months

Other outcomes

Locations

This trial has no locations.

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