Fuwai Hospital, Chinese Academy of MedicL Sciences
Beijing, 100061, China
Location status: Recruiting
NCT Number: NCT07400549
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, 100061, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Patients meeting any of the following criteria will be excluded:
physician training/assessment + patient exercise guidance via the mini-program + patient social support group activities
physicians receiving training/assessment in addition to conducting patient exercise guidance autonomously
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")
Time frame: from baseline to Month 3
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
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
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
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
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.
Time frame: from baseline to Month 3
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.
Time frame: from baseline to Month 3
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.
Time frame: from baseline to Month 3
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.
Time frame: from baseline to Month 3
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.
Time frame: from baseline to Month 3
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.
Contact information is provided by the study sponsor or research team.
China National Center for Cardiovascular Diseases
Other Gov
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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