Promoting Zero-time Exercise in Patients With Coronary Heart Disease

Exercise Adherence Clinical Trial

Official title:

Effectiveness of a Smartphone App in Promoting Zero-time Exercise and Fitness in Patients With Coronary Heart Disease: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03464331
• Other study ID #: HKUCTR-2165
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2018
• Last updated: March 14, 2018
• Start date: October 18, 2016
• Est. completion date: July 30, 2018

Study information

• Verified date: March 2018
• Source: The University of Hong Kong
• Contact: Po Tai Chan, PhD
• Phone: (852) 96720440
• Email: noelptchan[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background Physical activity (PA), is an effective means of protecting against cardiovascular disease (CVD) development. PA refers to any skeletal muscle bodily movement that requires energy expenditure. Research shows that low- to moderate-intensity muscle endurance exercise, such as walking or brisk walking for about 15-20 minutes per day, is associated with a significantly lower CVD risk regardless of body mass index. Mobile technologies such as smartphone physical exercise apps offer a potentially cost-effective platform for facilitating regular exercise, allowing individuals to set goals, receiving feedback on achievements and health information for facilitating regular exercise. "Zero-time Exercise" (ZTE) is a new concept for physical activities (PA) and exercise promotion and can easily attract attention especially when most people believe that extra time is needed to do exercise. ZTE can be done easily during most time of day, while sitting, standing, walking or waiting. These include simple movements, such as stretching and resistance (endurance) movements of the head, neck and shoulders, chest and abdominal muscles and the upper and lower limbs. When ZTE is integrated into daily life and sustained with increasing intensity, the effects could be substantial, especially for those who are sedentary and have difficulties to meet the minimal requirements of 150 minutes of at least moderate PA per week. The term is also intended to motivate people to start with simple exercises (the 'Foot-in-the-door' approach), change the mindset (that exercises need much time, money and sweats) and overcome the inertia from a sedentary lifestyle to become more active. It could also be a way to promote mental health (such as increasing happiness) through PA or exercises and enjoying the fun and satisfaction from the rapid improvements in fitness performances. Having brought some easily observable benefits quickly to those who are willing to try for a few days, ZTE might lead to more intensive or vigorous exercises requiring extra time for greater benefits.

Objective:

To test the feasibility [recruitment, dropout, and adherence to PA] of using whatsapp as an inertia reminder to promote the adherence of Zero-time Exercises (ZTE) in patients with CHD.

Description:

Methods:

A 12-week single-blind randomised control design pilot study. 100 participants aged 18-69 years or above with proven stabilized acute coronary heart disease, physical inactive and having own smartphone with adequate internet technology literacy to operate the smartphone app and able to read and understand Chinese were recruited from the outpatient Cardiac Clinic in 3 hospitals.

The intervention group will be asked to practise ZTE either using the smartphone app or a zerotime exercise booklet with a focus on exercise adherence to at least 20-30 minutes per day, and on most and preferably all days of the week. The control group (CON) were asked to do deep breathing exercise at least 20 minutes daily. The exercise adherence of 25 participants in each EXP and CON groups are measured by activity trackers.

A mobile electronic whatsapp message was used as an anti- inertia reminder (AIR) to promote ZTE adherence. We used pictures with simple exercises to remind the participants in intervention group (EXP) to do ZTE regularly. Whatsapp reminders on deep breathing exercises are sent to CON. The frequency, format, whatsapp feedback and response to enquiry are the same as for EXP.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Aged 18-69 years;

• Stable CHD;

• Able to walk at normal speed for at least 15 min with no breathlessness;

• Have own smartphone and can operate a smartphone app;

• Have not downloaded and used the ZTE mobile app;

• Able to read and understand Chinese;

• Willing to come back at 3-month FU (the second face-to-face session, S2) for the measurements and/or intervention

Exclusion Criteria:

• Presence of medical conditions that might limit ability to perform moderate-intensity PA;

• Currently engaging in more than 150 minutes/week of moderate/vigorous PA

• Had revascularisation performed within past 3 months;

• Currently participating in another clinical trial and/or cardiac rehabilitation programme;

• Experience wearing an activity tracker;

• Experience using a smartphone app for exercises;

• Not a Hong Kong resident, or cannot communicate in Cantonese or Putonghua.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Exercise Adherence
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Zero-time exercises
The Investigators/research staff (RS) will help EXP download, operate the Zero-time exercises (ZTE) app and ZTE e-diary. The EXP can enter their goal for the chosen exercise by setting the target duration or number of completed repetitions, review their previous record, and compare their exercise frequency and time ranking with those of the other EXP. After the EXP uploads the goal and results to the ZTE e-diary, the data will be automatically sent to the ZTE app database for data analysis. The EXP will be given a paper diary to record their Zero-time exercises (ZTE). Twenty-five EXP will be given activity trackers (e.g. Fitbit) to record their steps/motion throughout the 3 months.
• relaxation exercises and deep-breathing exercises
The Investigators/RS will teach the CON group (CON) to do relaxation exercises (RE) and deep-breathing exercises (DBE) for at least 30 mins every day. They will be helped download and use the electronic diary (CON_e-diary) to record their RE and DBE. The CON will also be given a paper diary to record RE and DBE they have done if they prefer to use paper diary.

Locations

Country	Name	City	State
China	Grantham Hospital	Hong Kong
China	Pok Oi Hospital	Hong Kong
China	Ruttonjee Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the zero time exercise intervention	Adherence to zero time exercise intervention is calculated as the total time (duration) of ZTE done per week (as reported by participants) divided by total time (150 minutes per week as prescribed by the research team) of ZTE to be done per week. Seventy percent is considered as a good adherence rate.	3 months