Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
- Conditions
- Coronary Heart Disease
- Interventions
- Device: Exercise self-monitoringDevice: Exercise telemonitoring connects to healthcare platformProcedure: Standard careDevice: Exercise teleconsultationProcedure: Other CR components
- Registration Number
- NCT04330560
- Lead Sponsor
- University of Malaya
- 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: -
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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ex group Other CR components Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation) Com group Exercise self-monitoring Receive CR telerehabilitation (exercise self-monitoring + teleconsultation) Com group Exercise teleconsultation Receive CR telerehabilitation (exercise self-monitoring + teleconsultation) Ex group Exercise teleconsultation Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation) Com group Other CR components Receive CR telerehabilitation (exercise self-monitoring + teleconsultation) Ex group Exercise telemonitoring connects to healthcare platform Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation) C group Standard care Standard care - traditional center-based CR
- Primary Outcome Measures
Name Time Method Exercise capacity during exercise stress test 12 weeks Changes of metabolic equivalents (METs)
Exercise capacity during six-minutes walking test 12 weeks Changes of walking distance (meter)
Feasibility (Safety - cardiac adverse events) 12 weeks To inform the patient's safety on cardiac adverse events
Feasibility (Safety - hospital readmission) 12 weeks To inform the patient's safety on hospital readmission
Feasibility (Recruitment procedure) 12 weeks To inform the patient's acceptability towards recruitment procedure
Feasibility (Cardiac rehabilitation program adherence) 12 weeks To inform the patient's acceptability towards cardiac rehabilitation program adherence
Feasibility (Randomization procedure) 12 weeks To inform the patient's acceptability towards randomization procedure
Feasibility (Assessment adherence) 12 weeks To inform the patient's acceptability towards assessment adherence
- Secondary Outcome Measures
Name Time Method Exercise adherence - Exercise frequency 12 weeks Changes in patient's weekly exercise frequency.
Blood collection - high-density lipoproteins (HDL) 12 weeks Changes of high-density lipoproteins (HDL) (mmol/L)
Body mass index (BMI) (kg/m2) 12 weeks Changes of BMI (kg/m2)
Usability scale score 12 weeks 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.
Exercise adherence - Steps count 12 weeks Changes in patient's weekly steps count.
Exercise adherence - Exercise duration 12 weeks Changes in patient's weekly exercise duration (minutes).
Hospital readmission 12 weeks Changes of frequency of hospital readmission throughout the intervention
Cardiac adverse events 12 weeks Changes of frequency of cardiac adverse events throughout the intervention
Blood collection - serum cholesterol 12 weeks Changes of serum cholesterol (mmol/L)
Blood collection - triglyceride 12 weeks Changes of serum triglyceride (mmol/L)
Blood collection - low-density lipoprotein (LDL) 12 weeks Changes of low-density lipoprotein (LDL) (mmol/L)
Blood collection - Haemoglobin A1C (HA1c) 12 weeks Changes of Haemoglobin A1C (HA1c) (mmols/mol)
Participant's acceptance to the exercise-based telemonitoring 12 weeks Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session
Body mass (kg) 12 weeks Changes of body mass (kg)
Factors associated with non-adherence to cardiac rehabilitation program score 12 weeks 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 12 weeks 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 12 weeks 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.
Trial Locations
- Locations (1)
Rehabilitation Medicine, Pusat Perubatan Universiti Malaya
🇲🇾Kuala Lumpur, Malaysia