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CompletedNCT04059627Updated Aug 19, 2019

Feasibility of the "Heart-track" Rehabilitative Device Prototype

An interventional study of Heart Track in Cardiac Infarct and Cardiac Event, sponsored by Tan Tock Seng Hospital. Completed at 1 site in Singapore. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-19.

Sponsored by Tan Tock Seng Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jul 2018, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
21 Years to 65 Years
Sex
All
01

Study summary

Abstract Title: "Heart-track" cardiac rehabilitation device prototype designed for exercise training post coronary revascularisation: A usability study Background: Percutaneous Coronary Intervention (PCI) is a common surgical procedure for heart attack patients. International guidelines recommend that all patients complete phase two (outpatient) cardiac rehabilitation (CR) after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. Patients in our institution have suboptimal exercise compliance and effectiveness during cardiac rehabilitation. Root cause analysis identified 'lack of commitment', 'lack of care monitoring and continuity' and 'lack of motivation and engagement' to be key contributing factors. Yet, healthcare resource limitations necessitate innovation for care continuity and patient engagement. "Heart-track", a novel, app-based innovation was created. By 'game-ifying' cardiac rehabilitative exercise training program, "Heart-track" guides and tracks cardiac rehabilitation at home at patient's comfort.

Purpose: To explore experiences of app usability in terms of content, functionality and design of the prototype "Heart-track" app to improve user experience.

Methods: Twelve community-dwelling adults who are also active member of cardiac rehab support group, aged above 50, and undergone coronary revascularisation for acute myocardial infarction at least 1 year before were recruited. Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app. Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. Descriptive analysis of quantitative responses were analysed using IBM SPSS software version 19.0 (Armonk, NY: IBM Corp).

Read the detailed description

Abstract Title: "Heart-track" cardiac rehabilitation device prototype designed for exercise training post coronary revascularisation: A usability study Background: Percutaneous Coronary Intervention (PCI) is a common surgical procedure for heart attack patients. International guidelines recommend that all patients complete phase two (outpatient) cardiac rehabilitation (CR) after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission. Patients in our institution have suboptimal exercise compliance and effectiveness during cardiac rehabilitation. Root cause analysis identified 'lack of commitment', 'lack of care monitoring and continuity' and 'lack of motivation and engagement' to be key contributing factors. Yet, healthcare resource limitations necessitate innovation for care continuity and patient engagement. "Heart-track", a novel, app-based innovation was created. By 'game-ifying' cardiac rehabilitative exercise training program, "Heart-track" guides and tracks cardiac rehabilitation at home at patient's comfort.

Purpose: To explore experiences of app usability in terms of content, functionality and design of the prototype "Heart-track" app to improve user experience.

Methods: Twelve community-dwelling adults who are also active member of cardiac rehab support group, aged above 50, and undergone coronary revascularisation for acute myocardial infarction at least 1 year before were recruited. Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app. Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. Descriptive analysis of quantitative responses were analysed using IBM SPSS software version 19.0 (Armonk, NY: IBM Corp).

02

Conditions studied

  • Cardiac Infarct
  • Cardiac Event

Keywords

  • Cardiac Rehab
03

In context

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 12 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Tan Tock Seng Hospital is the lead sponsor of 103 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Minimum 21 to 65 years of age
  • conversational fluency in English
  • undergone coronary revascularisation for acute myocardial infarction within last 5 years
  • last documented ejection fraction of at least 40%
  • completed a minimum of eight supervised CR sessions
  • exercises at least once a week for a minimum duration of thirty minutes
  • at least 6 months' experience using a smartphone
  • recent experience(at least one months' experience) with any mobile app
  • displaying capacity for self-monitoring and entering data.

Exclusion criteria

Exclusion Criteria:

-Abnormal physiological response during exercise

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Experimental arm

    Participants were introduced to "Heart-Track" mobile app system and its navigational characteristics with standardised instructions. Each participant then performed a self-directed Cardiac rehabilitation session using the app.

    Device: Heart Track

Interventions

  • DeviceHeart Track

    Description of the device: Wearable heart rate sensors are used in Heart-track, and a receiver on a smartphone app. Real-time wireless heart rate data is sent to paired mobile device with a wireless distance of up to 10m. The sensor is able to monitor a heart rate range of 30 to 240 beats per minute. Another component of Heart-track is a "Heart-track" mobile app which captures and reflect real-time heart rate from the heart rate sensor. The mobile app also includes warm-up and cool down exercises that are gamified and supported on a smart-phone running on Android or iOS platforms. The HR sensor will be purchased by our collaborator, Immersive Play Pte Ltd.

06

What researchers measure

Primary outcomes

  1. Survey

    Participants rated their experience with the hardware and software components of "Heart Track", and their acceptance of it as a cardiac rehabilitation tool. The survey form is a likert-scale ( Strongly agree to strongly disagree) survey that asking subjects about their feedback and satisfaction about the Heart Track hardware and software, and overall experience using Heart Track.

    Time frame: through study completion, an average of 3 months

07

Study locations

1 site
  • Tan Tock Seng Hospital
    Singapore, Singapore
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04059627
Lead sponsor
Tan Tock Seng Hospital
Responsible party
Eng Chan Neoh (Senior Physiotherapist, Tan Tock Seng Hospital) — Principal investigator
First posted
Aug 16, 2019
Start date
Jul 1, 2018
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Last update
Aug 19, 2019

Study contacts

Eng Chuan Neoh, masters
study director · Senior Physiotherapist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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