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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older.

Willing to participate in the study and able to provide written informed consent.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enhanced Mini-Program Intervention

    Behavioral

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

  • Enhanced Control

    Behavioral

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: The Enhanced Mini-Program Intervention GroupExperimental treatment 1 intervention
Group B: The Enhanced Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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")

Time frame
from baseline to Month 3

Secondary outcomes

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).

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
from baseline to Month 3

Other outcomes

Sponsors and contacts

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