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Completed

NCT Number: NCT03922022

Exercise is Medicine: a Pilot Study

Background: Regular exercise is beneficial to patients with hypertension and/or diabetes mellitus. However, most patients cannot maintain exercise habit. The investigators had developed a program called the "exercise is medicine"(EIM), combining motivational technique, information technology use and teaching exercise techniques. Before using this intervention in a main randomized controlled trial, the investigators would like to test its feasibility and acceptability. It is hypothesized that this program is feasible and acceptable to patients.

Method: 40 patients with HT and/or DM will be recruited to attend the EIM intervention. Primary outcomes will be the rate of recruitment and rate of retention. Other clinical outcomes will be obtained before and immediately after the 12-week program.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lek Yuen Clinic

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinic systolic BP(SBP) higher than 130mmHg (for HT class) because the Hong Kong primary care office guideline, as of Jan 2019, regarded good control of SBP to be ≤130mmHg, OR HbA1c >7% (for DM class)
  • self-reported regular exercise of ≤3 times per week - this cut-off is arbitrary but people who exercise more than 3 times may have little space for improvement; and these patients will unlikely be referred to EIM when it is implemented in routine clinical practice, - 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) are excluded because there are other evidence-proven and well-structured programmes for these patients in the Hospital Authority (HA), for instance, pulmonary rehabilitation program conducted by physiotherapy and/or occupational therapist in HA. - - 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) are also excluded due to reports that vigorous exercise may increase blood pressure and led to retinal bleeding in these patients

Treatment and study plan

EIM exercise classes and intervention

Behavioral

This is a complex intervention. On recruitment, they will be seen by a nurse and counselled using motivational technique. They will then undergo a 12-week class. The exercise levels will be regularly feedback to the patients by use of mobile devices and trackers. Peer support is formed during the 12-week class. Resources to continue exercise will be provided to patients. Regular monitoring of physical improvement will be feedback to patients to encourage continued exercise.

Primary outcomes

  1. rate of retention

    Time frame: from recruitment to finish of the 12-week program

    rate of retention

  2. Rate of recruitment

    Time frame: from recruitment to the start of the 12-week program

    Rate of recruitment

Secondary outcomes

  1. Clinic blood pressure (BP)

    Time frame: on recruitment and after the 12- week class

    Clinical BP will be measured 3 times and the last 2 will be averaged

  2. HbA1c (glycosylated hemoglobin)

    Time frame: on recruitment and after the 12- week class

    for DM patients only

  3. Godin-Shephard Laiesure-Time Physical Activity Questoinnaire

    Time frame: on recruitment and after the 12- week class

    a validated questionnaire to detect change in exercise level

  4. body mass index (BMI)

    Time frame: on recruitment and after the 12- week class

    the weight and height of the patients will be measured

  5. body fat percentage

    Time frame: on recruitment and after the 12- week class

    body fat percentage

  6. lipid level

    Time frame: on recruitment and after the 12- week class

    this will include low-density lipoprotein, high-density lipoprotein, and total lipoprotein

  7. 9-item patient health questionnaire

    Time frame: on recruitment and after the 12- week class

    a validated questionnaire to detect depressive symptoms

  8. Generalized anxiety disorder-7

    Time frame: on recruitment and after the 12- week class

    a validated questionnaire to detect anxiety symptoms

  9. EQ-5D-5L

    Time frame: on recruitment and after the 12- week class

    a validated questionnaire to measure quality of life

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Exercise is Medicine for Chronic Diseases: a Pilot Study for Future Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2019
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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