Exercise is Medicine: a Cohort Study (EIM-cohort)
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
exercise is medicine
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
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)
Sites / Locations
- Lek Yuen ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EIM group
Arm Description
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)
Outcomes
Primary Outcome Measures
office blood pressure
office systolic blood pressure
Secondary Outcome Measures
serum lipid level
low density lipoprotein, high density lipoprotein, total cholesterol, triglyceride
body fat percentage
that will be measured by a validated machine
body mass index
body weight (in kilogram) divided by square of body height (in meter)
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
office blood pressure
office systolic and diastolic blood pressure
Full Information
NCT ID
NCT04249557
First Posted
January 21, 2020
Last Updated
August 28, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04249557
Brief Title
Exercise is Medicine: a Cohort Study
Acronym
EIM-cohort
Official Title
Exercise is Medicine: a Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EIM group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
exercise is medicine
Intervention Description
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 Outcome Measure Information:
Title
office blood pressure
Description
office systolic blood pressure
Time Frame
Change from Baseline Systolic Blood Pressure at 3 months
Secondary Outcome Measure Information:
Title
serum lipid level
Description
low density lipoprotein, high density lipoprotein, total cholesterol, triglyceride
Time Frame
baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
Title
body fat percentage
Description
that will be measured by a validated machine
Time Frame
baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
Title
body mass index
Description
body weight (in kilogram) divided by square of body height (in meter)
Time Frame
baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
Title
international physical activity questionnaire- short form
Description
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
Time Frame
baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
Title
office blood pressure
Description
office systolic and diastolic blood pressure
Time Frame
baseline, 12-month after recruitment (end-of-study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kam Pui Lee, MSc
Phone
2252 8562
Email
lkp032@cuhk.edu.hk
Facility Information:
Facility Name
Lek Yuen Clinic
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kam Pui Lee, Msc
Phone
+852 60996560
Email
Lkp032@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Kam pui Lee, Msc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Can share out after personal permission is obtained
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Exercise is Medicine: a Cohort Study
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