eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients

The Effectiveness of eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients：a Randomized Controlled Trial.

The goal of this randomized controlled trial is to compare the effect of eHealth-based cardiac rehabilitation with the effect of usual care on exercise capacity and qualify of life in patients after myocardial infarction.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Other: eHealth-based cardiac rehabilitation

Detailed Description

Cardiac rehabilitation can improve exercise capacity, life of quality, readmission rate and mortality rate for patients after myocardial infarction. International guidelines list cardiac rehabilitation after myocardial infarction as class IA recommendation. However, low participation rate of cardiac rehabilitation due to barriers such as lacking of time, transport or affordability issues is an unsolved problem worldwide.

eHealth, consisting of telemedicine, mobile health and personalized care using wearable devices has the potential to remove the barriers and become an effective model to deliver cardiac rehabilitation. Thus, we design a randomized controlled trial to compare the effect of a case manager-led eHealth-based cardiac rehabilitation program with usual care on the compliance, physical activity, quality of life, and cardiorespiratory fitness in patients after myocardial infarction.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hung-Jui Chuang, MD; Phone Number: 67034 00886-2-23123456; Email: 103311@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Hung-Jui Chuang, MD; Phone Number: 67034 00886-2-23123456; Email: Rexintwo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. ≥ 20 years of age.
2. Within 6 months after the onset of acute myocardial infarction.
3. At lowest to moderate risk according to the guideline from American Association of Cardiovascular and Pulmonary Rehabilitation.
4. Unable or refused to attend center-based cardiac rehabilitation.

Exclusion criteria:

1. Unable to walk independently or use a stationary bike.
2. Unable to follow verbal command.
3. Not having a smartphone which can get on the internet.
4. Having contraindications for exercise according to American College of Sports Medicine's Guidelines for Exercise Testing and Prescription.
5. Unable to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eHealth-based cardiac rehabilitation; Participants receive a 12-wk case manager-led eHealth-based cardiac rehabilitation program with follow-up at 12 week, 6 months and 12 months.	Other: eHealth-based cardiac rehabilitation; The 12-wk case manager-led eHCR program includes: Individualized exercise prescription according to the results of cardiopulmonary exercise test.; At least one session of in-person physical therapy to familiarize participants with the process of exercise training before the initiation of telerehabilitation.; Telerehabilitation: a 30-minute moderate aerobic exercise training with remote monitoring and instruction using video conferencing. (Frequency: twice per week in the first 4 weeks, once per week in the 5th-8th week, once every 2 weeks in the 9th-12th week); Additional self-exercise to achieve the target volume of 150-minute moderate aerobic exercise and 2 sessions of resistance training per week.; Patient education for secondary prevention delivered regularly via a communication app on the smartphone.; Weekly follow-up call from a case manager via phone call or communication app.; Other Names: eHCR
No Intervention: Usual care; Participants receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of peak oxygen uptake	Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.	at baseline, 12 weeks(post-intervention), and 12 months.
Change of ventilatory anaerobic threshold	Ventilatory anaerobic threshold will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.	at baseline, 12 weeks(post-intervention), and 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to prescribed exercise	The degree of completion of prescribed exercise will be assessed at 12 weeks and 12 months.	at 12 weeks(post-intervention) and 12 months.
Evaluation of Quality of life	The investigators will assess the change in 36-Item Short Form Survey(SF-36).	at baseline, 12 weeks(post-intervention), and 12 months.
Depression	The investigators will assess the change in Patient Health Questionnaire (PHQ-9). The PHQ-9 score ranges from 0-27. Higher scores indicate worsen symptoms.	at baseline, 12 weeks(post-intervention), and 12 months.
Anxiety	The investigators will assess the change in Generalized Anxiety Disorder scale (GAD-7). The GAD-7 score ranges 0-21. Higher scores indicate worsen symptoms.	at baseline, 12 weeks(post-intervention), and 12 months.
Evaluation of physical activity	The investigators will assess the change in physical activity using Long form International Physical Activity Questionnaire(IPAQ) Taiwan version.	at baseline, 12 weeks(post-intervention), and 12 months.
Evaluation of grip strength	The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees.	at baseline, 12 weeks(post-intervention), and 12 months.
Evaluation of isometric knee extension strength	The isometric knee extension strength will be measured using a dynamometer with participants seated and knee flexed at 90 degrees.	at baseline, 12 weeks(post-intervention), and 12 months.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hung-Jui Chuang, MD, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: myocardial infarction; telerehabilitation; cardiac rehabilitation
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 202207060RINC

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