Exercise is Medicine: a Cohort Study (EIM-cohort)

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

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: exercise is medicine

• Study Type: Interventional
• Enrollment (Estimated): 6000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kam Pui Lee, MSc; Phone Number: 2252 8562; Email: lkp032@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Lek Yuen Clinic
    • Contact: Kam Pui Lee, Msc; Phone Number: +852 60996560; Email: Lkp032@cuhk.edu.hk
    • Principal Investigator: Kam pui Lee, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EIM group; 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; 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: EIM-cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Can share out after personal permission is obtained

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No