Exercise is Medicine: a Cohort Study

Study Overview
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Brief Summary
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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

Official Title
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Exercise is Medicine: a Cohort Study

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: exercise is medicine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EIM group<br>This contains: A 12-week Exercise is medicine teaching class containing 6-18 patients per group (class size may be limited by social distancing policy in Hong Kong), homework are prescribed to participants to encourage regular exercise. The exercise level will be recorded by a tracker and provides feedback to the participants and physical trainer. The physical parameters such as fat percentage and blood pressure level will be feedback to the patients to encourage exercise. (If sports center are closed by the Government, the classes will be conducted online) | Behavioral: exercise is medicine<br>* a 12-week exercise classes program combined with other motivational skills, including feedback and information technology support. The whole program lasts for 1 year for each participant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| office blood pressure | office systolic blood pressure | Change from Baseline Systolic Blood Pressure at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| office blood pressure | office systolic and diastolic blood pressure | baseline, 12-month after recruitment (end-of-study) |