NCT07400549
Recruiting
Not Applicable
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 Diseases1 site in 1 country100 target enrollmentStarted: June 1, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- China National Center for Cardiovascular Diseases
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in mean daily step count
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 years or older.
- •Willing to participate in the study and able to provide written informed consent.
- •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.
- •Capable of using a smartphone.
- •A local permanent resident who receives basic public health service management at the designated community health center/station or township hospital.
- •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:
- •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.
- •Current malignant tumor or history of malignant tumor within the past five years.
- •Contraindications to exercise, such as bone and joint diseases.
- •Severe respiratory diseases, including asthma, chronic obstructive pulmonary disease (COPD), restricted lung volume (due to obesity, pregnancy, or spinal deformity), or cystic fibrosis.
- •Neuromuscular and degenerative diseases, such as muscular dystrophy, poliomyelitis, and dementia.
- •Severe mental illness, including schizophrenia, bipolar disorder, eating disorders, or depression (with hospitalization for the condition within the past 6 months).
- •Movement and other neurological disorders, such as Huntington's disease, torsion dystonia, Parkinson's disease, and certain epileptic disorders.
- •Severe comorbidities with a life expectancy of less than 24 months.
- •Plans to relocate from the area within the next three months.
Arms & Interventions
The Enhanced Control Group
Active Comparator
Intervention: Enhanced Control (Behavioral)
The Enhanced Mini-Program Intervention Group
Experimental
Intervention: Enhanced Mini-Program Intervention (Behavioral)
Outcomes
Primary Outcomes
Change in mean daily step count
Time Frame: from baseline to Month 3
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")
Secondary Outcomes
- Change from Baseline in Average Daily Moderate-to-Vigorous Physical Activity (MVPA) Time (minutes/day) Measured by HLWH005 Accelerometer-Based Wearable(from baseline to Month 3)
- Change from Baseline in Maximum Handgrip Strength (kg) Measured by CAMRY EH101 Hand Dynamometer(from baseline to Month 3)
- Change from Baseline in Body Mass Index (BMI) (kg/m²) Based on Measured Height and Weight(from baseline to Month 3)
- Change from Baseline in Waist-to-Height Ratio (unitless) Based on Measured Waist Circumference and Height(from baseline to Month 3)
- Change from Baseline in Waist-to-Hip Ratio (unitless) Based on Measured Waist and Hip Circumference(from baseline to Month 3)
- Change from Baseline in Resting Systolic Blood Pressure (mmHg) Measured by HELOWIN TE-7003Y-C Automated Arm Cuff(from baseline to Month 3)
- Change from Baseline in Glycated Hemoglobin (HbA1c) (%) Measured by Laboratory Assay(from baseline to Month 3)
- Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) Concentration (mmol/L) Measured by Laboratory Assay(from baseline to Month 3)
- Change from Baseline in Serum Uric Acid Concentration (µmol/L) Measured by Laboratory Assay(from baseline to Month 3)
- High Adherence Rate to the Mini-Program-Based Exercise Plan (%) Assessed by Mini-Program Check-in Logs and Social-Support Attendance Records (Intervention Group Only)(from baseline to Month 3)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Multi-Domain Exercise Program In Older WomenNCT07311265Universidade do Oeste de Santa Catarina108
Recruiting
Not Applicable
Exercise as Medicine: A Non-Pharmacological Approach to Menopausal SymptomsNCT07351006Linnaeus University45
Unknown
Not Applicable
Traditional Exercise RCT in Visually Impaired AdultsNCT07265024Northeast Normal University90
Recruiting
Not Applicable
Effectiveness of a Physical Exercise Prescription Program in Primary Care for Adults Aged 65 and Older: PREFIS-APNCT07394790Instituto de Investigación Biomédica de Salamanca210
Recruiting
Not Applicable
Exercise Approaches and Physical Activity Level in Inactive AdultsNCT07411248Biruni University30