Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330560
• Other study ID #: 2018112-6846
• Secondary ID: RF009C-2018
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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
• 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.
• Exercise teleconsultation
Conducted through smartphone video call app.

Procedure:
• Other CR components
Including dietary, psychology, education conducted at the center.
• Standard care
Undergoing standard care by cardiac rehabilitation at the center

Locations

Country	Name	City	State
Malaysia	Rehabilitation Medicine, Pusat Perubatan Universiti Malaya	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility (Recruitment procedure)	To inform the patient's acceptability towards recruitment procedure	12 weeks
Primary	Feasibility (Randomization procedure)	To inform the patient's acceptability towards randomization procedure	12 weeks
Primary	Feasibility (Cardiac rehabilitation program adherence)	To inform the patient's acceptability towards cardiac rehabilitation program adherence	12 weeks
Primary	Feasibility (Assessment adherence)	To inform the patient's acceptability towards assessment adherence	12 weeks
Primary	Feasibility (Safety - hospital readmission)	To inform the patient's safety on hospital readmission	12 weeks
Primary	Feasibility (Safety - cardiac adverse events)	To inform the patient's safety on cardiac adverse events	12 weeks
Primary	Exercise capacity during exercise stress test	Changes of metabolic equivalents (METs)	12 weeks
Primary	Exercise capacity during six-minutes walking test	Changes of walking distance (meter)	12 weeks
Secondary	Exercise adherence - Steps count	Changes in patient's weekly steps count.	12 weeks
Secondary	Exercise adherence - Exercise frequency	Changes in patient's weekly exercise frequency.	12 weeks
Secondary	Exercise adherence - Exercise duration	Changes in patient's weekly exercise duration (minutes).	12 weeks
Secondary	Hospital readmission	Changes of frequency of hospital readmission throughout the intervention	12 weeks
Secondary	Cardiac adverse events	Changes of frequency of cardiac adverse events throughout the intervention	12 weeks
Secondary	Blood collection - serum cholesterol	Changes of serum cholesterol (mmol/L)	12 weeks
Secondary	Blood collection - triglyceride	Changes of serum triglyceride (mmol/L)	12 weeks
Secondary	Blood collection - high-density lipoproteins (HDL)	Changes of high-density lipoproteins (HDL) (mmol/L)	12 weeks
Secondary	Blood collection - low-density lipoprotein (LDL)	Changes of low-density lipoprotein (LDL) (mmol/L)	12 weeks
Secondary	Blood collection - Haemoglobin A1C (HA1c)	Changes of Haemoglobin A1C (HA1c) (mmols/mol)	12 weeks
Secondary	Body mass (kg)	Changes of body mass (kg)	12 weeks
Secondary	Body mass index (BMI) (kg/m2)	Changes of BMI (kg/m2)	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Participant's acceptance to the exercise-based telemonitoring	Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session	12 weeks