Coronary Heart DiseaseNCT04330560
Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
A study testing Exercise telemonitoring connects to healthcare platform, Exercise self-monitoring and Exercise teleconsultation in people with Coronary Heart Disease, run by University of Malaya at 1 site in Malaysia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Exercise telemonitoring connects to healthcare platform, Exercise self-monitoring and Exercise teleconsultation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Rehabilitation Medicine, Pusat Perubatan Universiti Malaya
Kuala Lumpur, 59100
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Coronary Heart Disease
- Being tested
- Exercise telemonitoring connects to healthcare platform, Exercise self-monitoring, Exercise teleconsultation, Other CR components, Standard care
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise telemonitoring connects to healthcare platformDevice
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
Exercise self-monitoringDevice
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 teleconsultationDevice
Conducted through smartphone video call app.
Other CR componentsProcedure or surgery
Including dietary, psychology, education conducted at the center.
Standard careProcedure or surgery
Undergoing standard care by cardiac rehabilitation at the center
| Study group | Role | What they receive |
|---|---|---|
| Ex group | Experimental | Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation) Receives: Device: Exercise telemonitoring connects to healthcare platform; Device: Exercise teleconsultation; Procedure: Other CR components |
| Com group | Active comparator | Receive CR telerehabilitation (exercise self-monitoring + teleconsultation) Receives: Device: Exercise self-monitoring; Device: Exercise teleconsultation; Procedure: Other CR components |
| C group | Placebo comparator | Standard care - traditional center-based CR Receives: Procedure: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Recruitment procedure)
To inform the patient's acceptability towards recruitment procedure
Measured: 12 weeks
Feasibility (Randomization procedure)
To inform the patient's acceptability towards randomization procedure
Measured: 12 weeks
Feasibility (Cardiac rehabilitation program adherence)
To inform the patient's acceptability towards cardiac rehabilitation program adherence
Measured: 12 weeks
Feasibility (Assessment adherence)
To inform the patient's acceptability towards assessment adherence
Measured: 12 weeks
Feasibility (Safety - hospital readmission)
To inform the patient's safety on hospital readmission
Measured: 12 weeks
Feasibility (Safety - cardiac adverse events)
To inform the patient's safety on cardiac adverse events
Measured: 12 weeks
Exercise capacity during exercise stress test
Changes of metabolic equivalents (METs)
Measured: 12 weeks
Exercise capacity during six-minutes walking test
Changes of walking distance (meter)
Measured: 12 weeks
Secondary outcomes (17)
Exercise adherence - Steps count
Changes in patient's weekly steps count.
Measured: 12 weeks
Exercise adherence - Exercise frequency
Changes in patient's weekly exercise frequency.
Measured: 12 weeks
Exercise adherence - Exercise duration
Changes in patient's weekly exercise duration (minutes).
Measured: 12 weeks
Hospital readmission
Changes of frequency of hospital readmission throughout the intervention
Measured: 12 weeks
Cardiac adverse events
Changes of frequency of cardiac adverse events throughout the intervention
Measured: 12 weeks
Blood collection - serum cholesterol
Changes of serum cholesterol (mmol/L)
Measured: 12 weeks
Blood collection - triglyceride
Changes of serum triglyceride (mmol/L)
Measured: 12 weeks
Blood collection - high-density lipoproteins (HDL)
Changes of high-density lipoproteins (HDL) (mmol/L)
Measured: 12 weeks
Blood collection - low-density lipoprotein (LDL)
Changes of low-density lipoprotein (LDL) (mmol/L)
Measured: 12 weeks
Blood collection - Haemoglobin A1C (HA1c)
Changes of Haemoglobin A1C (HA1c) (mmols/mol)
Measured: 12 weeks
Body mass (kg)
Changes of body mass (kg)
Measured: 12 weeks
Body mass index (BMI) (kg/m2)
Changes of BMI (kg/m2)
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 12 weeks
Participant's acceptance to the exercise-based telemonitoring
Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Dec 2020
- Primary completion26 May 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anwar Suhaimi, MBBS, Principal investigator, University of MalayaWan Ling Lee, PhD, Principal investigator, University of MalayaSanjay Rampal Lekhraj Rampal, PhD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330560
- Sponsor's protocol ID
- 2018112-6846
- Other IDs
- RF009C-2018
- Status last verified
- May 2024
- First submitted
- 25 Feb 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34741536
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04330560
- Acronym / sponsor ID
- 2018112-6846
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ex group | Experimental | Device: Exercise telemonitoring connects to healthcare platform, Device: Exercise teleconsultation, Procedure: Other CR componentsReceive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation) |
| Com group | Active comparator | Device: Exercise self-monitoring, Device: Exercise teleconsultation, Procedure: Other CR componentsReceive CR telerehabilitation (exercise self-monitoring + teleconsultation) |
| C group | Placebo comparator | Procedure: Standard careStandard care - traditional center-based CR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise telemonitoring connects to healthcare platformThe 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 | Device | Ex group |
| Exercise self-monitoringThe 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. | Device | Com group |
| Exercise teleconsultationConducted through smartphone video call app. | Device | Com group, Ex group |
| Other CR componentsIncluding dietary, psychology, education conducted at the center. | Procedure or surgery | Com group, Ex group |
| Standard careUndergoing standard care by cardiac rehabilitation at the center | Procedure or surgery | C group |
Primary outcome
Feasibility (Recruitment procedure)
Time frame: 12 weeks
To inform the patient's acceptability towards recruitment procedure
Feasibility (Randomization procedure)
Time frame: 12 weeks
To inform the patient's acceptability towards randomization procedure
Feasibility (Cardiac rehabilitation program adherence)
Time frame: 12 weeks
To inform the patient's acceptability towards cardiac rehabilitation program adherence
Feasibility (Assessment adherence)
Time frame: 12 weeks
To inform the patient's acceptability towards assessment adherence
Feasibility (Safety - hospital readmission)
Time frame: 12 weeks
To inform the patient's safety on hospital readmission
Feasibility (Safety - cardiac adverse events)
Time frame: 12 weeks
To inform the patient's safety on cardiac adverse events
Exercise capacity during exercise stress test
Time frame: 12 weeks
Changes of metabolic equivalents (METs)
Exercise capacity during six-minutes walking test
Time frame: 12 weeks
Changes of walking distance (meter)
17 secondary outcomes
Exercise adherence - Steps count
Time frame: 12 weeks
Exercise adherence - Exercise frequency
Time frame: 12 weeks
Exercise adherence - Exercise duration
Time frame: 12 weeks
Hospital readmission
Time frame: 12 weeks
Cardiac adverse events
Time frame: 12 weeks
Blood collection - serum cholesterol
Time frame: 12 weeks
Blood collection - triglyceride
Time frame: 12 weeks
Blood collection - high-density lipoproteins (HDL)
Time frame: 12 weeks
Blood collection - low-density lipoprotein (LDL)
Time frame: 12 weeks
Blood collection - Haemoglobin A1C (HA1c)
Time frame: 12 weeks
Body mass (kg)
Time frame: 12 weeks
Body mass index (BMI) (kg/m2)
Time frame: 12 weeks
Usability scale score
Time frame: 12 weeks
Factors associated with non-adherence to cardiac rehabilitation program score
Time frame: 12 weeks
Quality of life (QOL) score
Time frame: 12 weeks
Fitness tracker acceptance score
Time frame: 12 weeks
Participant's acceptance to the exercise-based telemonitoring
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 34741536Dibben 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anwar Suhaimi, MBBS principal investigator
University of Malaya
Wan Ling Lee, PhD principal investigator
University of Malaya
Sanjay Rampal Lekhraj Rampal, PhD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise telemonitoring connects to healthcare platform, Exercise self-monitoring and Exercise teleconsultation in people with Coronary Heart Disease, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Recruitment procedure) (time frame: 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.