Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: Exercise telemonitoring connects to healthcare platform; Device: Exercise teleconsultation; Procedure: Other CR components; Device: Exercise self-monitoring; Procedure: Standard care

Detailed Description

Feasibility study objective: - To investigate the feasibility and preliminary of exercise-based telerehabilitation before undertaking full-scale RCT.

Randomized control trial objective: -

1. Primary Objective: To determine the exercise capacity among patients with CHD,
2. 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Rehabilitation Medicine, Pusat Perubatan Universiti Malaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ex group; Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation)	Device: Exercise telemonitoring connects to healthcare platform; 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; Device: Exercise teleconsultation; Conducted through smartphone video call app.; Procedure: Other CR components; Including dietary, psychology, education conducted at the center.
ACTIVE_COMPARATOR: Com group; Receive CR telerehabilitation (exercise self-monitoring + teleconsultation)	Device: Exercise teleconsultation; Conducted through smartphone video call app.; Procedure: Other CR components; Including dietary, psychology, education conducted at the center.; Device: Exercise self-monitoring; 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.
PLACEBO_COMPARATOR: C group; Standard care - traditional center-based CR	Procedure: Standard care; Undergoing standard care by cardiac rehabilitation at the center

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Wan Ling Lee, PhD, University of Malaya; Principal Investigator: Sanjay Rampal Lekhraj Rampal, PhD, University of Malaya

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ACTUAL): May 26, 2021
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (ACTUAL): April 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2018112-6846; RF009C-2018 (OTHER_GRANT: University of Malaya Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No