Exercise is Medicine: a Pilot Study

Not Applicable

Completed

• Conditions: Hypertension; Diabetes Mellitus
• Interventions: Behavioral: EIM exercise classes and intervention

• Registration Number: NCT03922022
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-19
• Study Start: 2019-05-21
• Primary Completion: 2019-09-01
• Status Verified: 2019-12
• Study Completion: 2019-12-01
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EIM group	EIM exercise classes and intervention	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

Primary Outcome Measures

Name	Time	Method
Rate of recruitment	from recruitment to the start of the 12-week program	Rate of recruitment
rate of retention	from recruitment to finish of the 12-week program	rate of retention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lek Yuen Clinic; 🇭🇰 Hong Kong, Hong Kong