Clinical trial NCT04249557: Exercise is Medicine: a Cohort Study
Official title: Exercise is Medicine: a Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 6,000 patients with HT and/or DM will be recruited to participate a 12-week EIM exercise intervention, which also involve consistent feedback and reminders using information technology (IT). The primary outcome will be improvement of blood pressure at 1-year. Other clinical outcomes will be obtained on recruitment (baseline), 12-week (immediately after EIM classes) and 1-year after recruitment


Eligibility criteria: Inclusion Criteria:

* have a clinical diagnosis of primary HT and/or type II DM from clinical medical record
* having less than 150 minutes of moderate intensity exercise per week OR having less than 75 minutes of intensive intensity exercise per week (this is set according to latest World Health Organization guideline)
* who have used any mobile apps on their phone (because the intervention involve use of apps to monitor and remind regular exercise)

Exclusion Criteria:

* patients with diagnosed chronic obstructive lung disease and recent stroke (within last 12 months)
* Patients on 3 or more anti-hypertensive medications (on maximum or maximal tolerable doses) are excluded because these patients have resistant HT and may represent another spectrum of disease.
* Patients with spinal cord compression, radiculopathy with active pain, or osteoarthritis of hips and knees that are on the waiting list for joint replacement surgery are excluded for safety reasons.
* acute myocardial infarction in last 6 months
* ongoing angina
* uncontrolled cardiac arrhythmia
* acute diseases including known active endocarditis/acute pulmonary embolism, pulmonary infarction, deep vein thrombosis, acute aortic dissection, acute myocarditis
* known aortic stenosis
* known heart failure
* known obstructive left main coronary artery stenosis
* uncontrolled ventricular rates
* complete heart block
* known hypertrophic obstructive cardiomyopathy
* mental impairment that limit co-operation
* resting blood pressure with systolic blood pressure \>180mmHg or diastolic blood pressure \>110mmHg
* known anaemia with haemoglobin level less than 11gm/dL
* known uncorrected electrolyte imbalance
* known uncontrolled hyperthyroidism.
* For DM patients, patients with proliferative diabetic retinopathy and recent retinal bleeding (in last 12 months)

Primary outcomes:
measure: office blood pressure
timeFrame: Change from Baseline Systolic Blood Pressure at 3 months
Secondary outcomes:
measure: serum lipid level
timeFrame: baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
measure: body fat percentage
timeFrame: baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
measure: body mass index
timeFrame: baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
measure: international physical activity questionnaire- short form
timeFrame: baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
measure: office blood pressure
timeFrame: baseline, 12-month after recruitment (end-of-study)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Lek Yuen Clinic
Study officials:
References: