EIM-cohort: Exercise is Medicine: a Cohort Study

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04249557
Collaborator
(none)
6,000
1
1
53
113.2

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: exercise is medicine
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Exercise is Medicine: a Cohort Study
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. office blood pressure [Change from Baseline Systolic Blood Pressure at 3 months]

    office systolic blood pressure

Secondary Outcome Measures

  1. serum lipid level [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 [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 [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 [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 [baseline, 12-month after recruitment (end-of-study)]

    office systolic and diastolic blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lek Yuen Clinic Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lee Kam Pui, Clinical Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04249557
Other Study ID Numbers:
  • EIM-cohort
First Posted:
Jan 31, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022