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| ID | Type | Description | Link |
|---|---|---|---|
| RF009C-2018 | Other Grant/Funding Number | University of Malaya Grant |
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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
Feasibility study objective: - To investigate the feasibility and preliminary of exercise-based telerehabilitation before undertaking full-scale RCT.
Randomized control trial objective: -
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ex group | Experimental | Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation) |
|
| Com group | Active Comparator | Receive CR telerehabilitation (exercise self-monitoring + teleconsultation) |
|
| C group | Placebo Comparator | Standard care - traditional center-based CR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise telemonitoring connects to healthcare platform | Device | 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 |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anwar Suhaimi, MBBS | University of Malaya | Principal Investigator |
| Wan Ling Lee, PhD | University of Malaya | Principal Investigator |
| Sanjay Rampal Lekhraj Rampal, PhD | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Medicine, Pusat Perubatan Universiti Malaya | Kuala Lumpur | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34741536 | Derived | Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4. |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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The masking will be imposed on the investigator who will be involved with the recruitment of the participant to prevent selection bias. The allocation of the participant to a group will be randomised using computer-generated random numbers by the other investigator who did not involve in recruiting the participant.
| Exercise self-monitoring | Device | 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. |
|
| Exercise teleconsultation | Device | Conducted through smartphone video call app. |
|
| Other CR components | Procedure | Including dietary, psychology, education conducted at the center. |
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| Standard care | Procedure | Undergoing standard care by cardiac rehabilitation at the center |
|
| 12 weeks |
| 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 |