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Completed

NCT Number: NCT04249557

Exercise is Medicine: a Cohort Study

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lek Yuen Clinic

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

exercise is medicine

Behavioral

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

Primary outcomes

  1. office blood pressure

    Time frame: Change from Baseline Systolic Blood Pressure at 3 months

    office systolic blood pressure

Secondary outcomes

  1. serum lipid level

    Time frame: baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)

    low density lipoprotein, high density lipoprotein, total cholesterol, triglyceride

  2. body fat percentage

    Time frame: baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)

    that will be measured by a validated machine

  3. body mass index

    Time frame: baseline, 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)

  4. international physical activity questionnaire- short form

    Time frame: baseline, 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

  5. office blood pressure

    Time frame: baseline, 12-month after recruitment (end-of-study)

    office systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Acronym: EIM-cohort

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2020
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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