Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
Primary Purpose
Coronary Heart Disease
Status
Active
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Exercise telemonitoring connects to healthcare platform
Exercise self-monitoring
Exercise teleconsultation
Other CR components
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease
Eligibility Criteria
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.
Sites / Locations
- Rehabilitation Medicine, Pusat Perubatan Universiti Malaya
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Ex group
Com group
C group
Arm Description
Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation)
Receive CR telerehabilitation (exercise self-monitoring + teleconsultation)
Standard care - traditional center-based CR
Outcomes
Primary Outcome Measures
Feasibility (Recruitment procedure)
To inform the patient's acceptability towards recruitment procedure
Feasibility (Randomization procedure)
To inform the patient's acceptability towards randomization procedure
Feasibility (Cardiac rehabilitation program adherence)
To inform the patient's acceptability towards cardiac rehabilitation program adherence
Feasibility (Assessment adherence)
To inform the patient's acceptability towards assessment adherence
Feasibility (Safety - hospital readmission)
To inform the patient's safety on hospital readmission
Feasibility (Safety - cardiac adverse events)
To inform the patient's safety on cardiac adverse events
Exercise capacity during exercise stress test
Changes of metabolic equivalents (METs)
Exercise capacity during six-minutes walking test
Changes of walking distance (meter)
Secondary Outcome Measures
Exercise adherence - Steps count
Changes in patient's weekly steps count.
Exercise adherence - Exercise frequency
Changes in patient's weekly exercise frequency.
Exercise adherence - Exercise duration
Changes in patient's weekly exercise duration (minutes).
Hospital readmission
Changes of frequency of hospital readmission throughout the intervention
Cardiac adverse events
Changes of frequency of cardiac adverse events throughout the intervention
Blood collection - serum cholesterol
Changes of serum cholesterol (mmol/L)
Blood collection - triglyceride
Changes of serum triglyceride (mmol/L)
Blood collection - high-density lipoproteins (HDL)
Changes of high-density lipoproteins (HDL) (mmol/L)
Blood collection - low-density lipoprotein (LDL)
Changes of low-density lipoprotein (LDL) (mmol/L)
Blood collection - Haemoglobin A1C (HA1c)
Changes of Haemoglobin A1C (HA1c) (mmols/mol)
Body mass (kg)
Changes of body mass (kg)
Body mass index (BMI) (kg/m2)
Changes of BMI (kg/m2)
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.
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."
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.
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.
Participant's acceptance to the exercise-based telemonitoring
Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session
Full Information
NCT ID
NCT04330560
First Posted
February 25, 2020
Last Updated
November 1, 2022
Sponsor
University of Malaya
1. Study Identification
Unique Protocol Identification Number
NCT04330560
Brief Title
Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ex group
Arm Type
Experimental
Arm Description
Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation)
Arm Title
Com group
Arm Type
Active Comparator
Arm Description
Receive CR telerehabilitation (exercise self-monitoring + teleconsultation)
Arm Title
C group
Arm Type
Placebo Comparator
Arm Description
Standard care - traditional center-based CR
Intervention Type
Device
Intervention Name(s)
Exercise telemonitoring connects to healthcare platform
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Exercise self-monitoring
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Exercise teleconsultation
Intervention Description
Conducted through smartphone video call app.
Intervention Type
Procedure
Intervention Name(s)
Other CR components
Intervention Description
Including dietary, psychology, education conducted at the center.
Intervention Type
Procedure
Intervention Name(s)
Standard care
Intervention Description
Undergoing standard care by cardiac rehabilitation at the center
Primary Outcome Measure Information:
Title
Feasibility (Recruitment procedure)
Description
To inform the patient's acceptability towards recruitment procedure
Time Frame
12 weeks
Title
Feasibility (Randomization procedure)
Description
To inform the patient's acceptability towards randomization procedure
Time Frame
12 weeks
Title
Feasibility (Cardiac rehabilitation program adherence)
Description
To inform the patient's acceptability towards cardiac rehabilitation program adherence
Time Frame
12 weeks
Title
Feasibility (Assessment adherence)
Description
To inform the patient's acceptability towards assessment adherence
Time Frame
12 weeks
Title
Feasibility (Safety - hospital readmission)
Description
To inform the patient's safety on hospital readmission
Time Frame
12 weeks
Title
Feasibility (Safety - cardiac adverse events)
Description
To inform the patient's safety on cardiac adverse events
Time Frame
12 weeks
Title
Exercise capacity during exercise stress test
Description
Changes of metabolic equivalents (METs)
Time Frame
12 weeks
Title
Exercise capacity during six-minutes walking test
Description
Changes of walking distance (meter)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Exercise adherence - Steps count
Description
Changes in patient's weekly steps count.
Time Frame
12 weeks
Title
Exercise adherence - Exercise frequency
Description
Changes in patient's weekly exercise frequency.
Time Frame
12 weeks
Title
Exercise adherence - Exercise duration
Description
Changes in patient's weekly exercise duration (minutes).
Time Frame
12 weeks
Title
Hospital readmission
Description
Changes of frequency of hospital readmission throughout the intervention
Time Frame
12 weeks
Title
Cardiac adverse events
Description
Changes of frequency of cardiac adverse events throughout the intervention
Time Frame
12 weeks
Title
Blood collection - serum cholesterol
Description
Changes of serum cholesterol (mmol/L)
Time Frame
12 weeks
Title
Blood collection - triglyceride
Description
Changes of serum triglyceride (mmol/L)
Time Frame
12 weeks
Title
Blood collection - high-density lipoproteins (HDL)
Description
Changes of high-density lipoproteins (HDL) (mmol/L)
Time Frame
12 weeks
Title
Blood collection - low-density lipoprotein (LDL)
Description
Changes of low-density lipoprotein (LDL) (mmol/L)
Time Frame
12 weeks
Title
Blood collection - Haemoglobin A1C (HA1c)
Description
Changes of Haemoglobin A1C (HA1c) (mmols/mol)
Time Frame
12 weeks
Title
Body mass (kg)
Description
Changes of body mass (kg)
Time Frame
12 weeks
Title
Body mass index (BMI) (kg/m2)
Description
Changes of BMI (kg/m2)
Time Frame
12 weeks
Title
Usability scale score
Description
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.
Time Frame
12 weeks
Title
Factors associated with non-adherence to cardiac rehabilitation program score
Description
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."
Time Frame
12 weeks
Title
Quality of life (QOL) score
Description
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.
Time Frame
12 weeks
Title
Fitness tracker acceptance score
Description
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.
Time Frame
12 weeks
Title
Participant's acceptance to the exercise-based telemonitoring
Description
Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anwar Suhaimi, MBBS
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wan Ling Lee, PhD
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjay Rampal Lekhraj Rampal, PhD
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Medicine, Pusat Perubatan Universiti Malaya
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34741536
Citation
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.
Results Reference
derived
Learn more about this trial
Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
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