- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04074057
Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation
August 28, 2019 updated by: Eng Chan Neoh, Tan Tock Seng Hospital
Effectiveness of a Novel Mobile App Based Cardiac Rehabilitation Compared to Traditional Centre-based, Therapist Driven Cardiac Rehabilitation for Patients Post Coronary Revascularisation : A Non-inferiority Pilot Study
n Tan Tock Seng (TTSH), Acute myocardial infarction (AMI) is one of the top 4 reasons for admissions with 948 percutaneous coronary intervention (PCI) procedures done in year 2016.
International guidelines recommend that all patients complete CR after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission.
However, the rate of completion of CR has been found to be low as only 19% of post PCI patients completed CR in 2016.
According to a patient survey conducted, the main reason for non-completion is the inconvenience experienced by patients from needing to return to hospital weekly.
In addition, poor compliance to prescribed home exercises limits the effectiveness of exercise training.
Hence, there is a pertinent need to activate patients to engage in self-directed CR in a safe and effective manner to target these issues.
Current solutions to increase participation and compliance involve strategies have been limited.
Participation and compliance to prescribed exercises recorded via brochures and activity diaries have been limited by difficulties experienced by patients when providing this information, posing a risk of recall bias or the risk of misplacing their activity logs.
Mobile applications targeted at increasing fitness addresses the problem of the risk of misplacing activity logs but is still subjected to recall bias as self-input of multiple data is required.
Exercise guidelines within these applications are also generic and does not adhere to international exercise training guidelines targeted at patients after coronary revascularisation.
In order to address these gaps, there is a need for a technology enabled solution that can provide evidence-based CR programme with constant HR monitoring which offers direct feedback to the patients and at the same time affordable and easy to use.
"Heart-Track" is a novel mobile app based CR model of care that utilises a technology-enabled device designed specifically for patients post PCI to complete CR at their convenience, while ensuring that evidence-based clinical outcomes are achieved.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In Tan Tock Seng (TTSH), Acute myocardial infarction (AMI) is one of the top 4 reasons for admissions with 948 percutaneous coronary intervention (PCI) procedures done in year 2016.
International guidelines recommend that all patients complete CR after PCI, as it plays a critical role in reducing five-year cardiovascular mortality and the risk of cardiovascular-related hospital admission.
However, the rate of completion of CR has been found to be low as only 19% of post PCI patients completed CR in 2016.
According to a patient survey conducted, the main reason for non-completion is the inconvenience experienced by patients from needing to return to hospital weekly.
In addition, poor compliance to prescribed home exercises limits the effectiveness of exercise training.
Hence, there is a pertinent need to activate patients to engage in self-directed CR in a safe and effective manner to target these issues.
Current solutions to increase participation and compliance involve strategies have been limited.
Participation and compliance to prescribed exercises recorded via brochures and activity diaries have been limited by difficulties experienced by patients when providing this information, posing a risk of recall bias or the risk of misplacing their activity logs.
Mobile applications targeted at increasing fitness addresses the problem of the risk of misplacing activity logs but is still subjected to recall bias as self-input of multiple data is required.
Exercise guidelines within these applications are also generic and does not adhere to international exercise training guidelines targeted at patients after coronary revascularisation.
In order to address these gaps, there is a need for a technology enabled solution that can provide evidence-based CR programme with constant HR monitoring which offers direct feedback to the patients and at the same time affordable and easy to use.
"Heart-Track" is a novel mobile app based CR model of care that utilises a technology-enabled device designed specifically for patients post PCI to complete CR at their convenience, while ensuring that evidence-based clinical outcomes are achieved.
The key components of "Heart-Track" are: 1. Exercise principles based on international guidelines 2. Gamification; 3. Continuous heart rate monitoring; 4. Adaptation to local context.
As Heart-track is the first of its kind, being designed for use in the local context, findings from research is important in determining its efficacy when compared to traditional cardiac rehabilitation.
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Singapore, Singapore
- Recruiting
- Tan Tock Seng Hospital
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Contact:
- Eng Chuan Neoh, masters
- Phone Number: 91733222
- Email: eng_chuan_neoh@ttsh.com.sg
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 21-65 years old
- Underwent coronary revascularisation follow AMI
- Language literacy English or Mandarin
- Owns a smart phone
- Normal physiological response during exercise testing
- Low or moderate risk following risk stratification.
Exclusion Criteria:
- Medically unfit for exercise
- Post op complication
- High risk following risk stratification
- Cognitive impaired
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control arm
the control group will undergo a conventional weekly CR programme lasting 8-12 sessions.
Components of each session will include warm up, aerobic training, resistance exercises and cool down.
Patients are encouraged to continue their home exercises, exercising another 2 times a week at home and record down using an activity diary.
The importance of CR programme and exercise advice will be explained and reinforced by the CR Physiotherapist.
The submaximal exercise test and a body composition analysis will be repeated on the final assessment.
Every week research coordinator will call the subject to remind them to exercise.
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conventional weekly CR programme lasting 8-12 sessions.
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Other: Intervention arm
During the initial assessment, the importance of CR and regular exercise will be explained and reinforced by CR physiotherapist.
A research assistant will teach the patient how to use "Heart Track".
The patient will then bring "Heart Track" home to continue their CR program.
Patient will then undergo the whole CR programme to exercise for 3 times a day for 8-12 weeks using "Heart Track".
Each "Heart Track" session will include warm up, aerobic training, resistance exercises and cool down (same as the traditional CR session).
After 8-12 weeks, patient will be called back to the clinic by the research assistant to complete the final assessment (sub-maximal exercise test and a body composition analysis) with the blinded assessor.
Every week research coordinator will call the subject to remind them to exercise.
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Key components of "Heart-Track" are a heart rate sensor, a mobile app and a remote monitoring portal.
The "Heart-Track" mobile app is synchronized/ connected to Polar heart rate sensor through bluetooth in order to provide continous heart rate monitoring when subjects are exercising.
This is to ensure safety and exercise effectiveness.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 minutes walk test
Time Frame: through study completion, an average of 1 year
|
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
The MCID for 6MWD in patients with CAD after ACS was 25m.
|
through study completion, an average of 1 year
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Body weight
Time Frame: through study completion, an average of 1 year
|
Body weight will be assessed , record in kg
|
through study completion, an average of 1 year
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Body Height
Time Frame: through study completion, an average of 1 year
|
Body height will be assessed, record in meter
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through study completion, an average of 1 year
|
Body Mass Index
Time Frame: through study completion, an average of 1 year
|
Measure of body fat based on height and weight that applies to adult men and women.
Calculated by using body weight and height (kg/m2)
|
through study completion, an average of 1 year
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Body Fat Percentage
Time Frame: through study completion, an average of 1 year
|
Assess using a bioelectrical impedance analysis (BIA) method, record in percentage %
|
through study completion, an average of 1 year
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Skeletal muscle mass
Time Frame: through study completion, an average of 1 year
|
Assess using a bioelectrical impedance analysis (BIA) method, record in kg
|
through study completion, an average of 1 year
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Waist Hip Ratio
Time Frame: through study completion, an average of 1 year
|
Assess using a bioelectrical impedance analysis (BIA) method
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through study completion, an average of 1 year
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Borg's RPE scale
Time Frame: through study completion, an average of 1 year
|
Rating of perceived exertion (RPE) is a widely used and reliable indicator to monitor and guide exercise intensity.
The scale allows individuals to subjectively rate their level of exertion during exercise or exercise testing.
body fat,Skeletal muscle mass, Waist-hip ratio can be measured by using the body composition analysis machine.
Borg scale 6-20, 6 is very very light and 20 is very very hard.
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through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Efficacy for Exercise Scale•
Time Frame: through study completion, an average of 1 year
|
This scale is a self-report of exercise self-efficacy.
Total score is calculated by summing the responses to each question.
This scale has a range of total scores from 0-90.
A higher score indicates higher self-efficacy for exercise.
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through study completion, an average of 1 year
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Health related QoL: MacNew myocardial infarction Quality of life questionnaire
Time Frame: through study completion, an average of 1 year
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|
through study completion, an average of 1 year
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Patient-reported survey on usability of Heart Track acceptability
Time Frame: through study completion, an average of 1 year
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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.
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through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eng Chuan Neoh, masters, Senior Physiotherapist
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Anticipated)
May 31, 2020
Study Completion (Anticipated)
May 31, 2020
Study Registration Dates
First Submitted
August 20, 2019
First Submitted That Met QC Criteria
August 28, 2019
First Posted (Actual)
August 29, 2019
Study Record Updates
Last Update Posted (Actual)
August 29, 2019
Last Update Submitted That Met QC Criteria
August 28, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/00977
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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