Exercise is Medicine: a Pilot Study

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922022
• Other study ID #: NTEC-2019-0121
• Status: Completed
• Phase: N/A
• Start date: May 21, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Intervention

Behavioral:
• EIM exercise classes and intervention
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.

Locations

Country	Name	City	State
Hong Kong	Lek Yuen Clinic	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of retention	rate of retention	from recruitment to finish of the 12-week program
Primary	Rate of recruitment	Rate of recruitment	from recruitment to the start of the 12-week program
Secondary	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
Secondary	HbA1c (glycosylated hemoglobin)	for DM patients only	on recruitment and after the 12- week class
Secondary	Godin-Shephard Laiesure-Time Physical Activity Questoinnaire	a validated questionnaire to detect change in exercise level	on recruitment and after the 12- week class
Secondary	body mass index (BMI)	the weight and height of the patients will be measured	on recruitment and after the 12- week class
Secondary	body fat percentage	body fat percentage	on recruitment and after the 12- week class
Secondary	lipid level	this will include low-density lipoprotein, high-density lipoprotein, and total lipoprotein	on recruitment and after the 12- week class
Secondary	9-item patient health questionnaire	a validated questionnaire to detect depressive symptoms	on recruitment and after the 12- week class
Secondary	Generalized anxiety disorder-7	a validated questionnaire to detect anxiety symptoms	on recruitment and after the 12- week class
Secondary	EQ-5D-5L	a validated questionnaire to measure quality of life	on recruitment and after the 12- week class