Rehabilitation Medicine, Pusat Perubatan Universiti Malaya
Kuala Lumpur, 59100, Malaysia
NCT Number: NCT04330560
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kuala Lumpur, 59100, Malaysia
Feasibility study objective: - To investigate the feasibility and preliminary of exercise-based telerehabilitation before undertaking full-scale RCT.
Randomized control trial objective: -
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Conducted through smartphone video call app.
Including dietary, psychology, education conducted at the center.
Undergoing standard care by cardiac rehabilitation at the center
Time frame: 12 weeks
To inform the patient's acceptability towards recruitment procedure
Time frame: 12 weeks
To inform the patient's acceptability towards randomization procedure
Time frame: 12 weeks
To inform the patient's acceptability towards cardiac rehabilitation program adherence
Time frame: 12 weeks
To inform the patient's acceptability towards assessment adherence
Time frame: 12 weeks
To inform the patient's safety on hospital readmission
Time frame: 12 weeks
To inform the patient's safety on cardiac adverse events
Time frame: 12 weeks
Changes of metabolic equivalents (METs)
Time frame: 12 weeks
Changes of walking distance (meter)
Time frame: 12 weeks
Changes in patient's weekly steps count.
Time frame: 12 weeks
Changes in patient's weekly exercise frequency.
Time frame: 12 weeks
Changes in patient's weekly exercise duration (minutes).
Time frame: 12 weeks
Changes of frequency of hospital readmission throughout the intervention
Time frame: 12 weeks
Changes of frequency of cardiac adverse events throughout the intervention
Time frame: 12 weeks
Changes of serum cholesterol (mmol/L)
Time frame: 12 weeks
Changes of serum triglyceride (mmol/L)
Time frame: 12 weeks
Changes of high-density lipoproteins (HDL) (mmol/L)
Time frame: 12 weeks
Changes of low-density lipoprotein (LDL) (mmol/L)
Time frame: 12 weeks
Changes of Haemoglobin A1C (HA1c) (mmols/mol)
Time frame: 12 weeks
Changes of body mass (kg)
Time frame: 12 weeks
Changes of BMI (kg/m2)
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session
University of Malaya
Other
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
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