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

July 15, 2024 updated by: Lee Kam Pui, Chinese University of Hong Kong
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Lek Yuen Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
office blood pressure
Time Frame: Change from Baseline Systolic Blood Pressure at 3 months
office systolic blood pressure
Change from Baseline Systolic Blood Pressure at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
serum lipid level
Time Frame: 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
baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
body fat percentage
Time Frame: baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
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
Time Frame: 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)
baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
international physical activity questionnaire- short form
Time Frame: 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
baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study)
office blood pressure
Time Frame: baseline, 12-month after recruitment (end-of-study)
office systolic and diastolic blood pressure
baseline, 12-month after recruitment (end-of-study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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