Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support Tools in the Management of Patients With "Four Highs" (Hypertension, Hyperglycemia, Hyperlipidemia, Hyperuricemia)

China National Center for Cardiovascular Diseases100 enrolled

Overview

This study conducted a six-month exploratory clinical trial to evaluate the impact of an exercise prescription mini-program, based on the "Exercise Guidelines for the 'Four Highs'", on the physical activity levels and related health indicators of patients with hypertension, hyperglycemia, hyperlipidemia, and hyperuricemia in primary healthcare settings in China.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hypertension Hyperglycemia Hyperlipidemia Hyperuricemia Digital Intervention

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 years or older. 2. Willing to participate in the study and able to provide written informed consent. 3. Diagnosed with at least one of the following "Four Highs" conditions: Hypertension: Diagnosed primary hypertension, defined as seated office SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg on at least three non-consecutive days, or currently taking antihypertensive medication. Blood pressure must be controlled while on four or more antihypertensive agents. Diabetes Mellitus: Diagnosed diabetes, defined as having typical symptoms plus random plasma glucose ≥ 11.1 mmol/L, or fasting plasma glucose ≥ 7.0 mmol/L, or 2-hour plasma glucose during OGTT ≥ 11.1 mmol/L, or HbA1c ≥ 6.5%, or currently taking glucose-lowering medication. HbA1c level must be between 6.5% and 13.0%. Hyperlipidemia: Diagnosed hyperlipidemia, defined as total cholesterol (TC) ≥ 6.22 mmol/L, or LDL-C ≥ 4.14 mmol/L, or HDL-C \< 1.04 mmol/ L, or triglycerides (TG) \> 2.26 mmol/L, or currently taking lipid-lowering medication. Hyperuricemia: Diagnosed hyperuricemia, defined as a fasting serum uric acid level \> 420 μmol/L (7 mg/dL) in men and postmenopausal women, or \> 360 μmol/L (6 mg/dL) in premenopausal women, on two non-consecutive days under a normal purine diet, or currently taking urate-lowering medication. 4. Capable of using a smartphone. 5. A local permanent resident who receives basic public health service management at the designated community health center/station or township hospital. 6. Has not engaged in regular moderate- to vigorous-intensity physical activity (defined as at least 30 minutes per session, on at least 3 days per week) in the past three months. Exclusion Criteria: Patients meeting any of the following criteria will be excluded: 1. History or acute episode of cardiovascular or cerebrovascular disease, including: angina pectoris, myocardial infarction, coronary revascularization surgery, stroke (ischemic or hemorrhagic, including transient ischemic attack), symptomatic peripheral arterial disease requiring surgery or diagnosed by vascular imaging, ventricular arrhythmia, uncontrolled atrial fibrillation, congestive heart failure (New York Heart Association Class III or IV), hypertrophic cardiomyopathy, history of aneurysm with diameter ≥ 5.5 cm or prior aneurysm surgery. 2. Current malignant tumor or history of malignant tumor within the past five years. 3. Contraindications to exercise, such as bone and joint diseases. 4. Severe respiratory diseases, including asthma, chronic obstructive pulmonary disease (COPD), restricted lung volume (due to obesity, pregnancy, or spinal deformity), or cystic fibrosis. 5. Neuromuscular and degenerative diseases, such as muscular dystrophy, poliomyelitis, and dementia. 6. Severe mental illness, including schizophrenia, bipolar disorder, eating disorders, or depression (with hospitalization for the condition within the past 6 months). 7. Movement and other neurological disorders, such as Huntington's disease, torsion dystonia, Parkinson's disease, and certain epileptic disorders. 8. Severe comorbidities with a life expectancy of less than 24 months. 9. Plans to relocate from the area within the next three months. 10. Participation in other physical activity level intervention programs within the six months prior to the screening visit. 11. Current participation in another randomized clinical trial. 12. Any other condition that, in the investigator's judgment, may interfere with adherence to the trial protocol.

Outcomes

Primary Outcomes

Change in mean daily step count

The calculation of changes in average daily step count is defined as the difference between the average daily step count during the 7-day period prior to intervention (hereafter referred to as "the pre-intervention week") and the average daily step count during the final 7-day period of the third intervention month (hereafter referred to as "the final intervention week")