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Completed

NCT Number: NCT04330560

Exercise-based Telerehabilitation in 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Medicine, Pusat Perubatan Universiti Malaya

Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise telemonitoring connects to healthcare platform

Device

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

Device

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

Device

Conducted through smartphone video call app.

Other CR components

Procedure

Including dietary, psychology, education conducted at the center.

Standard care

Procedure

Undergoing standard care by cardiac rehabilitation at the center

Primary outcomes

  1. Feasibility (Recruitment procedure)

    Time frame: 12 weeks

    To inform the patient's acceptability towards recruitment procedure

  2. Feasibility (Randomization procedure)

    Time frame: 12 weeks

    To inform the patient's acceptability towards randomization procedure

  3. Feasibility (Cardiac rehabilitation program adherence)

    Time frame: 12 weeks

    To inform the patient's acceptability towards cardiac rehabilitation program adherence

  4. Feasibility (Assessment adherence)

    Time frame: 12 weeks

    To inform the patient's acceptability towards assessment adherence

  5. Feasibility (Safety - hospital readmission)

    Time frame: 12 weeks

    To inform the patient's safety on hospital readmission

  6. Feasibility (Safety - cardiac adverse events)

    Time frame: 12 weeks

    To inform the patient's safety on cardiac adverse events

  7. Exercise capacity during exercise stress test

    Time frame: 12 weeks

    Changes of metabolic equivalents (METs)

  8. Exercise capacity during six-minutes walking test

    Time frame: 12 weeks

    Changes of walking distance (meter)

Secondary outcomes

  1. Exercise adherence - Steps count

    Time frame: 12 weeks

    Changes in patient's weekly steps count.

  2. Exercise adherence - Exercise frequency

    Time frame: 12 weeks

    Changes in patient's weekly exercise frequency.

  3. Exercise adherence - Exercise duration

    Time frame: 12 weeks

    Changes in patient's weekly exercise duration (minutes).

  4. Hospital readmission

    Time frame: 12 weeks

    Changes of frequency of hospital readmission throughout the intervention

  5. Cardiac adverse events

    Time frame: 12 weeks

    Changes of frequency of cardiac adverse events throughout the intervention

  6. Blood collection - serum cholesterol

    Time frame: 12 weeks

    Changes of serum cholesterol (mmol/L)

  7. Blood collection - triglyceride

    Time frame: 12 weeks

    Changes of serum triglyceride (mmol/L)

  8. Blood collection - high-density lipoproteins (HDL)

    Time frame: 12 weeks

    Changes of high-density lipoproteins (HDL) (mmol/L)

  9. Blood collection - low-density lipoprotein (LDL)

    Time frame: 12 weeks

    Changes of low-density lipoprotein (LDL) (mmol/L)

  10. Blood collection - Haemoglobin A1C (HA1c)

    Time frame: 12 weeks

    Changes of Haemoglobin A1C (HA1c) (mmols/mol)

  11. Body mass (kg)

    Time frame: 12 weeks

    Changes of body mass (kg)

  12. Body mass index (BMI) (kg/m2)

    Time frame: 12 weeks

    Changes of BMI (kg/m2)

  13. Usability scale score

    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.

  14. Factors associated with non-adherence to cardiac rehabilitation program score

    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."

  15. Quality of life (QOL) score

    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.

  16. Fitness tracker acceptance score

    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.

  17. Participant's acceptance to the exercise-based telemonitoring

    Time frame: 12 weeks

    Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Apr 1, 2020
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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