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Exercise is Medicine: a Cohort Study

Exercise is Medicine: a Cohort Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04249557
Acronym
EIM-cohort
Enrollment
6000
Registered
2020-01-31
Start date
2020-07-01
Completion date
2024-06-30
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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

Interventions

BEHAVIORALexercise is medicine

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

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
office blood pressureChange from Baseline Systolic Blood Pressure at 3 monthsoffice systolic blood pressure

Secondary

MeasureTime frameDescription
serum lipid levelbaseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)low density lipoprotein, high density lipoprotein, total cholesterol, triglyceride
body fat percentagebaseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)that will be measured by a validated machine
body mass indexbaseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)body weight (in kilogram) divided by square of body height (in meter)
international physical activity questionnaire- short formbaseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)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
office blood pressurebaseline, 12-month after recruitment (end-of-study)office systolic and diastolic blood pressure

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026