Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program

Study Overview
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Brief Summary
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The intervention will involve a system that comprises a wrist-worn activity tracker and a smartphone app that acts as a medium to link to the healthcare website

Detailed Description
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Feasibility study objective: - To investigate the feasibility and preliminary of exercise-based telerehabilitation before undertaking full-scale RCT. Randomized control trial objective: - Primary Objective: To determine the exercise capacity among patients with CHD, Secondary Objectives: To assess patient exercise adherence and determine the changes in other clinical health outcomes. Study Population: Patients with coronary heart disease Description of Sites/Facilities Enrolling Participants: Patient engagement with the cardiac rehabilitation phase 2 (CRP2) at the University Malaya Medical Centre (UMMC). Description of Study Intervention: This study is a mixed-methods study consisting of a quantitative study (feasibility, preliminary evaluation, and full randomized control trial) and a qualitative study (interviewing). The present study will be conducting a single-blinded, three-arm, parallel over a 12-weeks study period during CRP2. Measurement will be collected during pre-and post-test.

Official Title
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Feasibility and Preliminary Evaluation and the Effects of Exercise-based Telerehabilitation on the Acceptability and Safety, and Clinical Effectiveness Among Patients With Coronary Heart Disease Undergoing the Cardiac Rehabilitation Program

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Exercise telemonitoring connects to healthcare platform
* Device: Exercise self-monitoring
* Device: Exercise teleconsultation
* Procedure: Other CR components
* Procedure: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with 18 years old and above with indexed diagnosis of coronary heart disease (CHD) and are referred for Cardiac Rehabilitation Program; Low- and moderate-risk patient category (controlled BP, sinus rhythm at 60-90 bpm, pain score< 3/10) and received a statement of medical clearance by a CR physician to undertake exercise with minimal supervision; The patient is willing to wear trackers during waking hours, own a personal smartphone and have access to internet/Wi-Fi; and Participant must be able to able to read, speak and understand English and Malay. Exclusion Criteria: Heart failure NYHA Stage 3-4, pulse undetected by trackers; The participant who cannot detect their pulse through wrist-worn tracker; Do not own a smartphone with the mobile internet/Wi-Fi ; and Contraindicated for an exercise stress test and concomitant morbidity that limit physical activity and exercise.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ex group<br>Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation) | Device: Exercise telemonitoring connects to healthcare platform<br>* The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) link to the healthcare practitioner<br>Device: Exercise teleconsultation<br>* Conducted through smartphone video call app.<br>Procedure: Other CR components<br>* Including dietary, psychology, education conducted at the center.<br>|
| Active Comparator: Com group<br>Receive CR telerehabilitation (exercise self-monitoring + teleconsultation) | Device: Exercise self-monitoring<br>* The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) for exercise self-monitoring.<br>Device: Exercise teleconsultation<br>* Conducted through smartphone video call app.<br>Procedure: Other CR components<br>* Including dietary, psychology, education conducted at the center.<br>|
| Placebo Comparator: C group<br>Standard care - traditional center-based CR | Procedure: Standard care<br>* Undergoing standard care by cardiac rehabilitation at the center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (Recruitment procedure) | To inform the patient's acceptability towards recruitment procedure | 12 weeks | 
| Feasibility (Randomization procedure) | To inform the patient's acceptability towards randomization procedure | 12 weeks | 
| Feasibility (Cardiac rehabilitation program adherence) | To inform the patient's acceptability towards cardiac rehabilitation program adherence | 12 weeks | 
| Feasibility (Assessment adherence) | To inform the patient's acceptability towards assessment adherence | 12 weeks | 
| Feasibility (Safety - hospital readmission) | To inform the patient's safety on hospital readmission | 12 weeks | 
| Feasibility (Safety - cardiac adverse events) | To inform the patient's safety on cardiac adverse events | 12 weeks | 
| Exercise capacity during exercise stress test | Changes of metabolic equivalents (METs) | 12 weeks | 
| Exercise capacity during six-minutes walking test | Changes of walking distance (meter) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise adherence - Steps count | Changes in patient's weekly steps count. | 12 weeks | 
| Exercise adherence - Exercise frequency | Changes in patient's weekly exercise frequency. | 12 weeks | 
| Exercise adherence - Exercise duration | Changes in patient's weekly exercise duration (minutes). | 12 weeks | 
| Hospital readmission | Changes of frequency of hospital readmission throughout the intervention | 12 weeks | 
| Cardiac adverse events | Changes of frequency of cardiac adverse events throughout the intervention | 12 weeks | 
| Blood collection - serum cholesterol | Changes of serum cholesterol (mmol/L) | 12 weeks | 
| Blood collection - triglyceride | Changes of serum triglyceride (mmol/L) | 12 weeks | 
| Blood collection - high-density lipoproteins (HDL) | Changes of high-density lipoproteins (HDL) (mmol/L) | 12 weeks | 
| Blood collection - low-density lipoprotein (LDL) | Changes of low-density lipoprotein (LDL) (mmol/L) | 12 weeks | 
| Blood collection - Haemoglobin A1C (HA1c) | Changes of Haemoglobin A1C (HA1c) (mmols/mol) | 12 weeks | 
| Body mass (kg) | Changes of body mass (kg) | 12 weeks | 
| Body mass index (BMI) (kg/m2) | Changes of BMI (kg/m2) | 12 weeks | 
| Usability scale score | Measured by using mHealth App Usability Questionnaire (MAUQ). Indicators are evaluated according to the seven-point Likert scale ranging from Strongly Disagree to Strongly Agree on smartphone app ease of use, interface and satisfaction, and usefulness. | 12 weeks | 
| Factors associated with non-adherence to cardiac rehabilitation program score | Measured by using Cardiac Rehabilitation Barriers Scale (CRBS) questionnaire. Indicators are evaluated according to the five-point Likert scale ranging from Strongly Disagree to Strongly Agree. | 12 weeks | 
| Quality of life (QOL) score | Measured by using WHO Quality of Life-BREF (WHOQOL-BREF) questionnaire. Indicators are evaluated according to the five-point Likert scale ranging from Strongly Disagree to Strongly Agree on the physical health, psychological, social relationship and environment. | 12 weeks | 
| Fitness tracker acceptance score | Measured by using Technology Acceptance Model (TAM) questionnaire. Indicators are evaluated according to the five-point Likert scale ranging from Strongly Disagree to Strongly Agree on the effort expectancy, performance expectancy, facilitating conditions, perceived enjoyment, perceived fee, perceived privacy, perceived trust, perceived value, social influence, perceived health increase and intention to use. | 12 weeks | 
| Participant's acceptance to the exercise-based telemonitoring | Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session | 12 weeks |