Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04074057
Other study ID # 2018/00977
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date May 31, 2020

Study information

Verified date August 2019
Source Tan Tock Seng Hospital
Contact Eng Chuan Neoh, Masters
Phone 91733222
Email eng_chuan_neoh@ttsh.com.sg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date May 31, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

1. 21-65 years old

2. Underwent coronary revascularisation follow AMI

3. Language literacy English or Mandarin

4. Owns a smart phone

5. Normal physiological response during exercise testing

6. Low or moderate risk following risk stratification.

Exclusion Criteria:

1. Medically unfit for exercise

2. Post op complication

3. High risk following risk stratification

4. Cognitive impaired

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional Cardiac Rehab Classes
conventional weekly CR programme lasting 8-12 sessions.
Device:
Heart Track
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.

Locations

Country Name City State
Singapore Tan Tock Seng Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 minutes walk test 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
Primary Body weight Body weight will be assessed , record in kg through study completion, an average of 1 year
Primary Body Height Body height will be assessed, record in meter through study completion, an average of 1 year
Primary Body Mass Index 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
Primary Body Fat Percentage Assess using a bioelectrical impedance analysis (BIA) method, record in percentage % through study completion, an average of 1 year
Primary Skeletal muscle mass Assess using a bioelectrical impedance analysis (BIA) method, record in kg through study completion, an average of 1 year
Primary Waist Hip Ratio Assess using a bioelectrical impedance analysis (BIA) method through study completion, an average of 1 year
Primary Borg's RPE scale 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. through study completion, an average of 1 year
Secondary Self-Efficacy for Exercise Scaleā€¢ 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. through study completion, an average of 1 year
Secondary Health related QoL: MacNew myocardial infarction Quality of life questionnaire The MacNew consists of 27 items which fall into three domains [a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale]. There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs.
Scores are reported using a descriptive scale which are described as: "all of the time", "most of the time", "a good bit of the time", "some of the time", "a little of the time", "hardly any of the time" and "none of the time"
The maximum possible score in any domain is 7 [high HRQL] and the minimum is 1 [poor HRQL]
through study completion, an average of 1 year
Secondary Patient-reported survey on usability of Heart Track acceptability 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. through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05490303 - HeartGuide: Preliminary Study N/A
Completed NCT05070819 - Atrial Natriuretic Peptide in Assessing Fluid Status N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT04511403 - Prevalence of Oral Mucosal Alterations In a Sample of Egyptian Patients With Cardiovascular Diseases: A Hospital- Based Cross-Sectional Study
Completed NCT02697760 - The CZT Dynamic Myocardial Perfusion Imaging
Terminated NCT05157568 - Pilot Randomized Clinical Trial of Live-streamed Cardiovascular Rehabilitation N/A
Not yet recruiting NCT04160845 - Non-invasive Forehead Skin Temperature in Cardiac Surgery
Completed NCT04500912 - Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population N/A
Not yet recruiting NCT06438159 - Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation. N/A
Recruiting NCT06154473 - Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit
Not yet recruiting NCT05877755 - Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging N/A
Completed NCT03394859 - Electronic Medical Records and Genomics (eMERGE) Phase III
Recruiting NCT05055830 - Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
Recruiting NCT04374799 - Heparin vs Placebo for Cardiac Catheterization Phase 3
Completed NCT03174106 - Longterm Follow-up of Cardiac Patients With an Smartphone-Application N/A
Recruiting NCT05531253 - Respired Gases in Patients Post Cardiac Surgery
Recruiting NCT04609228 - Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors
Recruiting NCT06149143 - Cardiac Performance System Data Collection Study - Minnesota
Recruiting NCT05725655 - Hot Water Immersion After Myocardial Infarction N/A
Recruiting NCT06073509 - Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT