Promoting Zero-time Exercise in Patients With Coronary Heart Disease

NCT03464331 | Unknown

• 1 other identifier: HKUCTR-2165
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Exercise Adherence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

EXP group

EXPERIMENTAL

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

CON group

PLACEBO COMPARATOR

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

Interventions

Zero-time exercises BEHAVIORAL

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.

EXP group

relaxation exercises and deep-breathing exercises BEHAVIORAL

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.

CON group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (3)

Grantham Hospital

Hong Kong, China

RECRUITING

Pok Oi Hospital

Hong Kong, China

RECRUITING

Ruttonjee Hospital

Hong Kong, China

RECRUITING

Related Publications (1)

• Chan NPT, Lai AYK, Choy HK, Cheung DYT, Wan ANT, Cheng VYH, Chan KY, Lau YK, Yung CY, Cheung GOC, Lam TH. Feasibility and Potential Effectiveness of a Smartphone Zero-Time Exercise Intervention for Promoting Physical Activity and Fitness in Patients With Coronary Heart Disease: A Pilot Randomized Controlled Trial. Front Public Health. 2022 Jul 14;10:865712. doi: 10.3389/fpubh.2022.865712. eCollection 2022.

  PMID: 35910893 DERIVED

Study Officials

• Po Tai Chan

  School of Nursing, HKU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Po Tai Chan, PhD

CONTACT

(852) 96720440; noelptchan@hku.hk

Po Tai Chan

CONTACT

(852) 96720440; noelptchan@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: October 18, 2016
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: March 15, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)