Exercise-prescription mini-program for people with high blood pressure, high blood sugar, high cholesterol, or high uric acid.

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)

This study will try a digital exercise-prescription mini-program to help adults with one or more of the 'Four Highs' increase physical activity and improve related health measures over six months in primary care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing)
• Trial ID: NCT07400549 on ClinicalTrials.gov

What this trial studies

This was a six-month interventional exploratory trial conducted in primary healthcare settings in China using an exercise prescription mini-program based on the "Exercise Guidelines for the 'Four Highs'." Participants meeting inclusion criteria received either an enhanced mini-program intervention or an enhanced control and were followed for changes in physical activity and clinical indicators. Outcomes included measures of physical activity and related cardiometabolic and metabolic markers (blood pressure, glucose control, lipids, and uric acid) collected in routine primary care visits. The lead site for the work was Fuwai Hospital, Chinese Academy of Medical Sciences in Beijing.

Who should consider this trial

Good fit: Adults aged 18 or older with at least one diagnosis of hypertension, diabetes/high blood sugar, hyperlipidemia, or hyperuricemia who can give written informed consent and receive care in participating primary healthcare settings are the intended candidates.

Not a fit: People who cannot use the digital mini-program, who have medical conditions outside the trial's inclusion ranges, or who require different medical interventions may not gain benefit from this approach.

Why it matters

Potential benefit: If successful, the program could help people increase activity and improve blood pressure, blood sugar, cholesterol, or uric acid through personalized, guideline-based exercise plans delivered digitally.

How similar studies have performed: Similar digital exercise-prescription and mobile health programs have shown promise for increasing physical activity and improving cardiometabolic risk factors, though applying a guideline-based program specifically for the Four Highs in primary care remains exploratory.

Eligibility criteria

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.

Where this trial is running

Beijing

• Fuwai Hospital, Chinese Academy of MedicL Sciences — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Tian

Conditions Hypertension; Hyperglycemia; Hyperlipidemia; Hyperuricemia; Digital Intervention; Digitally-Enabled Health; Chronic Disease Prevention and Control; Sports prescription