Exercise is Medicine: a Pilot Study

NCT03922022 | Completed

• 1 other identifier: NTEC-2019-0121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Clinic blood pressure (BP)

  on recruitment and after the 12- week class

• HbA1c (glycosylated hemoglobin)

  on recruitment and after the 12- week class

• Godin-Shephard Laiesure-Time Physical Activity Questoinnaire

  on recruitment and after the 12- week class

• body mass index (BMI)

  on recruitment and after the 12- week class

• body fat percentage

  on recruitment and after the 12- week class

Study Arms (1)

EIM group

EXPERIMENTAL

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

Interventions

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.

EIM group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Lek Yuen Clinic

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

Methods

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: May 21, 2019
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

HK (1)