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HypertensionNCT07400549

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)

A study testing Enhanced Mini-Program Intervention in people with Hypertension and Hyperglycemia, run by China National Center for Cardiovascular Diseases at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Hyperglycemia, Hyperlipidemia
What is being tested?
Enhanced Mini-Program Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Jun 2025to 1 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Fuwai Hospital, Chinese Academy of MedicL Sciences

    Beijing, 100061

    Tian, 86+88319206, sigaoresearch@163.com

    Recruiting

Other trials in China

About this study

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.

Being tested
Enhanced Mini-Program Intervention, Enhanced Control
Keywords
Digitally-Enabled Health, Chronic Disease Prevention and Control, Sports prescription, Primary health care (PHC)
Medical subject headings
Hypertension, Hyperglycemia, Hyperlipidemias, Hyperuricemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Mini-Program InterventionBehavioural

    physician training/assessment + patient exercise guidance via the mini-program + patient social support group activities

  • Enhanced ControlBehavioural

    physicians receiving training/assessment in addition to conducting patient exercise guidance autonomously

Study groups in NCT07400549
Study groupRoleWhat they receive
The Enhanced Mini-Program Intervention GroupExperimentalNot described
Receives: Behavioral: Enhanced Mini-Program Intervention
The Enhanced Control GroupActive comparatorNot described
Receives: Behavioral: Enhanced Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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")

    Measured: from baseline to Month 3

Secondary outcomes (10)
  1. Change from Baseline in Average Daily Moderate-to-Vigorous Physical Activity (MVPA) Time (minutes/day) Measured by HLWH005 Accelerometer-Based Wearable

    Average daily time (minutes/day) spent in MVPA, defined as activity intensity >100 steps/min, assessed using the HLWH005 accelerometer-based wearable device. MVPA will be calculated as the mean MVPA minutes per day over a 7-day monitoring period. The outcome is the change from the baseline 7-day period (pre-intervention week) to the final 7-day period of Month 3 (last week of intervention).

    Measured: from baseline to Month 3

  2. Change from Baseline in Maximum Handgrip Strength (kg) Measured by CAMRY EH101 Hand Dynamometer

    Maximum handgrip strength (kg) assessed using the CAMRY EH101 hand dynamometer. Grip strength will be measured in a standing position with the elbow extended and wrist in neutral position. Both hands will be assessed; each hand will be measured 3 times and the maximum value will be recorded. The outcome is the change from baseline to Month 3.

    Measured: from baseline to Month 3

  3. Change from Baseline in Body Mass Index (BMI) (kg/m²) Based on Measured Height and Weight

    BMI (kg/m²) calculated as weight (kg) / height (m)², using standard clinical measurements of body weight (calibrated digital scale) and height (stadiometer). The outcome is the change from baseline to Month 3.

    Measured: from baseline to Month 3

  4. Change from Baseline in Waist-to-Height Ratio (unitless) Based on Measured Waist Circumference and Height

    Waist-to-height ratio (unitless) calculated as waist circumference (cm) / height (cm). Waist circumference will be measured using a non-stretch measuring tape following standard clinical procedures; height will be measured using a stadiometer. The outcome is the change from baseline to Month 3.

    Measured: from baseline to Month 3

  5. Change from Baseline in Waist-to-Hip Ratio (unitless) Based on Measured Waist and Hip Circumference

    Waist-to-hip ratio (unitless) calculated as waist circumference (cm) / hip circumference (cm). Waist and hip circumference will be measured using a non-stretch measuring tape following standard clinical procedures. The outcome is the change from baseline to Month 3.

    Measured: from baseline to Month 3

  6. Change from Baseline in Resting Systolic Blood Pressure (mmHg) Measured by HELOWIN TE-7003Y-C Automated Arm Cuff

    Resting systolic blood pressure (mmHg) measured using the HELOWIN TE-7003Y-C automated upper-arm blood pressure monitor. After 5 minutes of seated rest, blood pressure will be measured 3 times at 5-minute intervals; the average of the 3 readings will be used. The outcome is the change from baseline to Month 3.

    Measured: from baseline to Month 3

  7. Change from Baseline in Glycated Hemoglobin (HbA1c) (%) Measured by Laboratory Assay

    HbA1c (%) measured from fasting venous blood samples analyzed at the local clinical laboratory using standard laboratory assay methods. The outcome is the change from baseline to Month 3.

    Measured: from baseline to Month 3

  8. Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) Concentration (mmol/L) Measured by Laboratory Assay

    LDL-C concentration (mmol/L) measured from fasting venous blood samples analyzed at the local clinical laboratory using standard laboratory assay methods. The outcome is the change from baseline to Month 3.

    Measured: from baseline to Month 3

  9. Change from Baseline in Serum Uric Acid Concentration (µmol/L) Measured by Laboratory Assay

    Serum uric acid concentration (µmol/L) measured from fasting venous blood samples analyzed at the local clinical laboratory using standard laboratory assay methods. The outcome is the change from baseline to Month 3.

    Measured: from baseline to Month 3

  10. 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)

    High adherence rate, defined as the percentage of participants in the mini-program intervention group who meet the pre-specified adherence criteria during the 3-month intervention period: (1) average weekly completion rate ≥70% for each of the three check-in modules ("aerobic exercise", "resistance exercise", and "step count") recorded in the mini-program logs; and (2) attendance at ≥2 monthly social-support group sessions recorded by attendance logs.

    Measured: from baseline to Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start1 Jun 2025
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07400549
Sponsor's protocol ID
FW-SG-2025-2635
Status last verified
Feb 2026
First submitted
25 Dec 2025
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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/s12966-024-01586-7.

    PubMed 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.

    PubMed 26277725
  • Heath L, Stevens R, Nicholson BD, Wherton J, Gao M, Callan C, Haasova S, Aveyard P. Strategies to improve the implementation of preventive care in primary care: a systematic review and meta-analysis. BMC Med. 2024 Sep 27;22(1):412. doi: 10.1186/s12916-024-03588-5.

    PubMed 39334345
  • Singh B, Ahmed M, Staiano AE, Gough C, Petersen J, Vandelanotte C, Kracht C, Huong C, Yin Z, Vasiloglou MF, Pan CC, Short CE, Mclaughlin M, von Klinggraeff L, Pfledderer CD, Moran LJ, Button AM, Maher CA. A systematic umbrella review and meta-meta-analysis of eHealth and mHealth interventions for improving lifestyle behaviours. NPJ Digit Med. 2024 Jul 5;7(1):179. doi: 10.1038/s41746-024-01172-y.

    PubMed 38969775
  • Kickbusch I, Piselli D, Agrawal A, Balicer R, Banner O, Adelhardt M, Capobianco E, Fabian C, Singh Gill A, Lupton D, Medhora RP, Ndili N, Rys A, Sambuli N, Settle D, Swaminathan S, Morales JV, Wolpert M, Wyckoff AW, Xue L; Secretariat of the Lancet and Financial Times Commission. The Lancet and Financial Times Commission on governing health futures 2030: growing up in a digital world. Lancet. 2021 Nov 6;398(10312):1727-1776. doi: 10.1016/S0140-6736(21)01824-9. Epub 2021 Oct 24. No abstract available.

    PubMed 34706260
  • Zangger G, Bricca A, Liaghat B, Juhl CB, Mortensen SR, Andersen RM, Damsted C, Hamborg TG, Ried-Larsen M, Tang LH, Thygesen LC, Skou ST. Benefits and Harms of Digital Health Interventions Promoting Physical Activity in People With Chronic Conditions: Systematic Review and Meta-Analysis. J Med Internet Res. 2023 Jul 6;25:e46439. doi: 10.2196/46439.

    PubMed 37410534
  • Kart O, Mevsim V, Kut A, Yurek I, Altin AO, Yilmaz O. A mobile and web-based clinical decision support and monitoring system for diabetes mellitus patients in primary care: a study protocol for a randomized controlled trial. BMC Med Inform Decis Mak. 2017 Nov 29;17(1):154. doi: 10.1186/s12911-017-0558-6.

    PubMed 29187186
  • Raghu A, Praveen D, Peiris D, Tarassenko L, Clifford G. Engineering a mobile health tool for resource-poor settings to assess and manage cardiovascular disease risk: SMARThealth study. BMC Med Inform Decis Mak. 2015 Apr 29;15:36. doi: 10.1186/s12911-015-0148-4.

    PubMed 25924825
  • Chen D, Zhang H, Wu J, Xue E, Guo P, Tang L, Shao J, Cui N, Wang X, Chen L, Ye Z. Effects of an Individualized mHealth-Based Intervention on Health Behavior Change and Cardiovascular Risk Among People With Metabolic Syndrome Based on the Behavior Change Wheel: Quasi-Experimental Study. J Med Internet Res. 2023 Nov 29;25:e49257. doi: 10.2196/49257.

    PubMed 38019579

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Mini-Program Intervention in people with Hypertension and Hyperglycemia, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tian (86+ 88319206, sigaoresearch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in mean daily step count (time frame: from baseline to Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07400549, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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Clinical Trial NCT07400549 | AzTrials