Hypertension Clinical Trial
— EIM-cohortOfficial title:
Exercise is Medicine: a Cohort Study
NCT number | NCT04249557 |
Other study ID # | EIM-cohort |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2020 |
Est. completion date | June 30, 2024 |
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
Status | Recruiting |
Enrollment | 6000 |
Est. completion date | June 30, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Lek Yuen Clinic | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | office blood pressure | office systolic blood pressure | Change from Baseline Systolic Blood Pressure at 3 months | |
Secondary | serum lipid level | low density lipoprotein, high density lipoprotein, total cholesterol, triglyceride | baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study) | |
Secondary | body fat percentage | that will be measured by a validated machine | baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study) | |
Secondary | body mass index | body weight (in kilogram) divided by square of body height (in meter) | baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study) | |
Secondary | international physical activity questionnaire- short form | assess the amount of exercise, physical activities and sitting time in the last 7 days. After asking the number of hours spent on walking, moderate intensity exercise and vigorous exercise, the amount of energy expenditure (in the unit MET-min/week) can be calculated. The higher the number, the higher the energy expenditure | baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study) | |
Secondary | office blood pressure | office systolic and diastolic blood pressure | baseline, 12-month after recruitment (end-of-study) |
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