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)

Обзор

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.

Вмешательства

• Поведенческое Enhanced Mini-Program Intervention
  physician training/assessment + patient exercise guidance via the mini-program + patient social support group activities
• Поведенческое Enhanced Control
  physicians receiving training/assessment in addition to conducting patient exercise guidance autonomously

Первичные конечные точки

• Change in mean daily step count [Срок оценки: from baseline to Month 3]

Вторичные конечные точки (10)

• Change from Baseline in Average Daily Moderate-to-Vigorous Physical Activity (MVPA) Time (minutes/day) Measured by HLWH005 Accelerometer-Based Wearable [Срок оценки: from baseline to Month 3]
• Change from Baseline in Maximum Handgrip Strength (kg) Measured by CAMRY EH101 Hand Dynamometer [Срок оценки: from baseline to Month 3]
• Change from Baseline in Body Mass Index (BMI) (kg/m²) Based on Measured Height and Weight [Срок оценки: from baseline to Month 3]
• Change from Baseline in Waist-to-Height Ratio (unitless) Based on Measured Waist Circumference and Height [Срок оценки: from baseline to Month 3]
• Change from Baseline in Waist-to-Hip Ratio (unitless) Based on Measured Waist and Hip Circumference [Срок оценки: from baseline to Month 3]
• Change from Baseline in Resting Systolic Blood Pressure (mmHg) Measured by HELOWIN TE-7003Y-C Automated Arm Cuff [Срок оценки: from baseline to Month 3]
• Change from Baseline in Glycated Hemoglobin (HbA1c) (%) Measured by Laboratory Assay [Срок оценки: from baseline to Month 3]
• Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) Concentration (mmol/L) Measured by Laboratory Assay [Срок оценки: from baseline to Month 3]
• Change from Baseline in Serum Uric Acid Concentration (µmol/L) Measured by Laboratory Assay [Срок оценки: 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) [Срок оценки: from baseline to Month 3]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.
• Participation in other physical activity level intervention programs within the six months prior to the screening visit.
• Current participation in another randomized clinical trial.
• Any other condition that, in the investigator's judgment, may interfere with adherence to the trial protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital, Chinese Academy of MedicL Sciences — Пекин

Публикации

• Egan BM. Physical Activity and Hypertension: Knowing Is Not Enough; We Must Apply. Willing Is Not Enough; We Must Do-von Goethe. Hypertension. 2017 Mar;69(3):404-406. doi: 10.1161/HYPERTENSIONAHA.116.08508. Epub 2017 Jan 30. No abstract available. PMID 28137989
• Colberg SR, Sigal RJ, Yardley JE, Riddell MC, Dunstan DW, Dempsey PC, Horton ES, Castorino K, Tate DF. Physical Activity/Exercise and Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care. 2016 Nov;39(11):2065-2079. doi: 10.2337/dc16-1728. No abstract available. PMID 27926890
• Sacks FM, Lichtenstein AH, Wu JHY, Appel LJ, Creager MA, Kris-Etherton PM, Miller M, Rimm EB, Rudel LL, Robinson JG, Stone NJ, Van Horn LV; American Heart Association. Dietary Fats and Cardiovascular Disease: A Presidential Advisory From the American Heart Association. Circulation. 2017 Jul 18;136(3):e1-e23. doi: 10.1161/CIR.0000000000000510. Epub 2017 Jun 15. PMID 28620111
• Piao W, Zhao L, Yang Y, Fang H, Ju L, Cai S, Yu D. The Prevalence of Hyperuricemia and Its Correlates among Adults in China: Results from CNHS 2015-2017. Nutrients. 2022 Oct 2;14(19):4095. doi: 10.3390/nu14194095. PMID 36235748
• Strain T, Flaxman S, Guthold R, Semenova E, Cowan M, Riley LM, Bull FC, Stevens GA; Country Data Author Group. National, regional, and global trends in insufficient physical activity among adults from 2000 to 2022: a pooled analysis of 507 population-based surveys with 5.7 million participants. Lancet Glob Health. 2024 Aug;12(8):e1232-e1243. doi: 10.1016/S2214-109X(24)00150-5. Epub 2024 Jun 25. PMID 38942042
• Smart NA, Downes D, van der Touw T, Hada S, Dieberg G, Pearson MJ, Wolden M, King N, Goodman SPJ. The Effect of Exercise Training on Blood Lipids: A Systematic Review and Meta-analysis. Sports Med. 2025 Jan;55(1):67-78. doi: 10.1007/s40279-024-02115-z. Epub 2024 Sep 27. PMID 39331324
• Wu J, Feng Y, Zhao Y, Guo Z, Liu R, Zeng X, Yang F, Liu B, Gu J, Tarimo CS, Shao W, Guo X, Li Q, Zhao L, Ma M, Shen Z, Zhao Q, Miao Y. Lifestyle behaviors and risk of cardiovascular disease and prognosis among individuals with cardiovascular disease: a systematic review and meta-analysis of 71 prospective cohort studies. Int J Behav Nutr Phys Act. 2024 Apr 22;21(1):42. doi: 10.1186/s12966-024-0158 PMID 38650004
• Hegde SM, Solomon SD. Influence of Physical Activity on Hypertension and Cardiac Structure and Function. Curr Hypertens Rep. 2015 Oct;17(10):77. doi: 10.1007/s11906-015-0588-3. PMID 26277725

Идентификаторы

NCT: NCT07400549 · FW-SG-2025-2635

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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