Promoting Zero-time Exercise in Patients With Coronary Heart Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03464331|
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : March 15, 2018
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Exercise Adherence||Behavioral: Zero-time exercises Behavioral: relaxation exercises and deep-breathing exercises||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Simple individual randomization method by sequentially numbered, opaque sealed envelopes (SNOSE) will be used to ensure the research staff / interventionists and participants will be concealed from the allocation sequence. The statistician will prepare about 150 identical, opaque, sealed, A5-sized envelops, with a unique 3-digit serial number on the cover of each envelope as an identifier. Half of them will each contain a card indicating EXP and the other half, CON. For EXP, the card will further indicate activity tracker or no tracker, in 1:1 ratio. After consent, the RS will open an envelope according to the sequence of the serial number and assign participant to either EXP or CON group. The envelop must be opened according to the serial number. All others will not know the group allocation before the envelope is opened. Frequent checks (at least weekly) of these numbers will be done to ensure no deviation.|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||October 18, 2016|
|Estimated Primary Completion Date :||July 30, 2018|
|Estimated Study Completion Date :||July 30, 2018|
Experimental: EXP group
Participants in EXP group (EXP) will be asked to practise Zero-time exercises (ZTE) at least 20-30 minutes per day, and on most and preferably all days of the week.
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.
Placebo Comparator: CON group
Participants in CON group (CON) will be asked to practise relaxation exercises (RE) and deep-breathing exercises (DBE) at least 30 mins every day.
Behavioral: 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.
- Adherence to the zero time exercise intervention [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464331
|Contact: Po Tai Chan, PhD||(852) email@example.com|
|Contact: Po Tai Chan||(852) firstname.lastname@example.org|
|Hong Kong, China|
|Contact: Fan Yue Yan, MBBS (852) 25182619 email@example.com|
|Pok Oi Hospital||Recruiting|
|Hong Kong, China|
|Contact: Yue Hong Cheng, MBBS (852) 66905411 firstname.lastname@example.org|
|Contact: Yue Hong Cheng (852) 66905411 email@example.com|
|Principal Investigator: Yue Hong Cheng, MBBS|
|Hong Kong, China|
|Contact: Chi Yui Yung, MBBS (852) 98102685 firstname.lastname@example.org|
|Principal Investigator: Chi Yui Yung, MBBS|
|Principal Investigator:||Po Tai Chan||School of Nursing, HKU|