Exercise is Medicine: a Pilot Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: EIM exercise classes and intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: patients will go to different classes: (i) Hypertension basic exercise class (ii) Hypertension advanced exercise class (iii) diabetes basic exercise class (iv) diabetes advanced exercise class; if the patient has normal BMI AND reported some regular exercise, they will be prescribed the advanced level class. There is no control group for this pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EIM group<br>patients will go to different classes: (i) Hypertension basic exercise class (ii) Hypertension advanced exercise class (iii) diabetes basic exercise class (iv) diabetes advanced exercise class; if the patient has normal BMI AND reported some regular exercise, they will be prescribed the advanced level class. There is no control group for this pilot study | Behavioral: EIM exercise classes and intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of retention | rate of retention | from recruitment to finish of the 12-week program | 
| Rate of recruitment | Rate of recruitment | from recruitment to the start of the 12-week program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic blood pressure (BP) | Clinical BP will be measured 3 times and the last 2 will be averaged | on recruitment and after the 12- week class | 
| HbA1c (glycosylated hemoglobin) | for DM patients only | on recruitment and after the 12- week class | 
| Godin-Shephard Laiesure-Time Physical Activity Questoinnaire | a validated questionnaire to detect change in exercise level | on recruitment and after the 12- week class | 
| body mass index (BMI) | the weight and height of the patients will be measured | on recruitment and after the 12- week class | 
| body fat percentage | body fat percentage | on recruitment and after the 12- week class | 
| lipid level | this will include low-density lipoprotein, high-density lipoprotein, and total lipoprotein | on recruitment and after the 12- week class | 
| 9-item patient health questionnaire | a validated questionnaire to detect depressive symptoms | on recruitment and after the 12- week class | 
| Generalized anxiety disorder-7 | a validated questionnaire to detect anxiety symptoms | on recruitment and after the 12- week class | 
| EQ-5D-5L | a validated questionnaire to measure quality of life | on recruitment and after the 12- week class |