Exercise is Medicine: a Cohort Study

NCT04249557 | Completed DMC

• 1 other identifier: EIM-cohort
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• office blood pressure

  office systolic blood pressure

  Change from Baseline Systolic Blood Pressure at 3 months

Secondary Outcomes (5)

• serum lipid level

  baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)

• body fat percentage

  baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)

• body mass index

  baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)

• international physical activity questionnaire- short form

  baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)

• office blood pressure

  baseline, 12-month after recruitment (end-of-study)

Study Arms (1)

EIM group

EXPERIMENTAL

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

Interventions

exercise is medicine 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

EIM group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Lek Yuen Clinic

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 31, 2020
• Study Start: July 1, 2020
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

HK (1)