Exercise is Medicine: a Cohort Study

NCT ID: NCT04249557

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2024-06-30

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

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

exercise is medicine

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lee Kam Pui

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lek Yuen Clinic

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

EIM-cohort

Identifier Type: -

Identifier Source: org_study_id