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NCT04249557Completed

Exercise is Medicine: a Cohort Study

Source: ClinicalTrials.gov · Last updated 16 Jul 2024

Brief summary (registry, in English)

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 (registry)
Completed
Study type
Interventional
Enrollment
6000 (actual)
First submitted
21 Jan 2020
Start date
1 Jul 2020
Primary completion date
30 May 2024
Lead sponsor
Chinese University of Hong Kong
NCT number
NCT04249557

What you commit to

  • Study type: Interventional
  • Participants enrolled: 6000
  • From 1 Jul 2020 to the primary completion date, 30 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.
  • 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 heart failure
  • complete heart block
  • mental impairment that limit co-operation
  • For DM patients, patients with proliferative diabetic retinopathy and recent retinal bleeding (in last 12 months)

Lab values

  • known anaemia with haemoglobin level less than 11gm/dL

Other

  • known aortic stenosis
  • known obstructive left main coronary artery stenosis
  • uncontrolled ventricular rates
  • known hypertrophic obstructive cardiomyopathy
  • resting blood pressure with systolic blood pressure \>180mmHg or diastolic blood pressure \>110mmHg
  • known uncorrected electrolyte imbalance
  • known uncontrolled hyperthyroidism.

Who the study is looking for

  • 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)

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lek Yuen Clinic
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.