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eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
eHealth-based cardiac rehabilitation
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring cardiac rehabilitation, telerehabilitation, myocardial infarction

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: ≥ 20 years of age. Within 6 months after the onset of acute myocardial infarction. At lowest to moderate risk according to the guideline from American Association of Cardiovascular and Pulmonary Rehabilitation. Unable or refused to attend center-based cardiac rehabilitation. Exclusion criteria: Unable to walk independently or use a stationary bike. Unable to follow verbal command. Not having a smartphone which can get on the internet. Having contraindications for exercise according to American College of Sports Medicine's Guidelines for Exercise Testing and Prescription. Unable to provide informed consent.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eHealth-based cardiac rehabilitation

Usual care

Arm Description

Participants receive a 12-wk case manager-led eHealth-based cardiac rehabilitation program with follow-up at 12 week, 6 months and 12 months.

Participants receive usual care.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Adherence to prescribed exercise
The degree of completion of prescribed exercise will be assessed at 12 weeks and 12 months.
Evaluation of Quality of life
The investigators will assess the change in 36-Item Short Form Survey(SF-36).
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.
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.
Evaluation of physical activity
The investigators will assess the change in physical activity using Long form International Physical Activity Questionnaire(IPAQ) Taiwan version.
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.
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.

Full Information

First Posted
January 3, 2023
Last Updated
April 23, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05689385
Brief Title
eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients
Official Title
The Effectiveness of eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients:a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
cardiac rehabilitation, telerehabilitation, myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eHealth-based cardiac rehabilitation
Arm Type
Experimental
Arm Description
Participants receive a 12-wk case manager-led eHealth-based cardiac rehabilitation program with follow-up at 12 week, 6 months and 12 months.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants receive usual care.
Intervention Type
Other
Intervention Name(s)
eHealth-based cardiac rehabilitation
Other Intervention Name(s)
eHCR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of peak oxygen uptake
Description
Peak oxygen uptake will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.
Time Frame
at baseline, 12 weeks(post-intervention), and 12 months.
Title
Change of ventilatory anaerobic threshold
Description
Ventilatory anaerobic threshold will be assessed using cardiopulmonary exercise test before intervention, at 12 weeks (post-intervention), and at 12 months.
Time Frame
at baseline, 12 weeks(post-intervention), and 12 months.
Secondary Outcome Measure Information:
Title
Adherence to prescribed exercise
Description
The degree of completion of prescribed exercise will be assessed at 12 weeks and 12 months.
Time Frame
at 12 weeks(post-intervention) and 12 months.
Title
Evaluation of Quality of life
Description
The investigators will assess the change in 36-Item Short Form Survey(SF-36).
Time Frame
at baseline, 12 weeks(post-intervention), and 12 months.
Title
Depression
Description
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.
Time Frame
at baseline, 12 weeks(post-intervention), and 12 months.
Title
Anxiety
Description
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.
Time Frame
at baseline, 12 weeks(post-intervention), and 12 months.
Title
Evaluation of physical activity
Description
The investigators will assess the change in physical activity using Long form International Physical Activity Questionnaire(IPAQ) Taiwan version.
Time Frame
at baseline, 12 weeks(post-intervention), and 12 months.
Title
Evaluation of grip strength
Description
The grip strength will be measured using a grip goniometer with the participants seated and the elbow flexed at 90 degrees.
Time Frame
at baseline, 12 weeks(post-intervention), and 12 months.
Title
Evaluation of isometric knee extension strength
Description
The isometric knee extension strength will be measured using a dynamometer with participants seated and knee flexed at 90 degrees.
Time Frame
at baseline, 12 weeks(post-intervention), and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: ≥ 20 years of age. Within 6 months after the onset of acute myocardial infarction. At lowest to moderate risk according to the guideline from American Association of Cardiovascular and Pulmonary Rehabilitation. Unable or refused to attend center-based cardiac rehabilitation. Exclusion criteria: Unable to walk independently or use a stationary bike. Unable to follow verbal command. Not having a smartphone which can get on the internet. Having contraindications for exercise according to American College of Sports Medicine's Guidelines for Exercise Testing and Prescription. Unable to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Jui Chuang, MD
Phone
00886-2-23123456
Ext
67034
Email
103311@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Jui Chuang, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Jui Chuang, MD
Phone
00886-2-23123456
Ext
67034
Email
rexintwo@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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eHealth-based Cardiac Rehabilitation in Post-myocardial Infarction Patients

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