Effects of Intelligent Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction

NCT ID: NCT01250600

Last Updated: 2010-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-04-30

Brief Summary

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Although a lot of evidence and guidelines recommend that patients have cardiac rehabilitation, in reality, the actual rate cardiac patients entering cardiac rehabilitation program is low, usually less than one third. One of the main hindrances of patients participating cardiac rehabilitation program is insufficient number of medical institutions that can provide rehabilitation services. Patients usually cannot perform exercise program under medical professionals monitoring without having to go far. This spatial and temporal difficulty led to the low rate of patients taking cardiac rehabilitation program. The risk of patients to do exercise is higher than healthy adult.

This project will develop the intelligent portable remote care system for cardiopulmonary exercise to provide an instant ECG monitoring service through the integration of front-end wireless ECG measuring devices, expert system, and back-end tele-care platform. Many patients are inconvenient to go to large hospital regularly for cardiac rehabilitation training. This project will help them to exercise at home after once or twice rehabilitation training in clinic for each month and the medical professional will supervise remotely to see how much exercise they did. For that reason the project can help to break through spatial and temporal difficulty of having cardiac rehabilitation, so that cardiac rehabilitation can be help more patients. Patients have this tele-care system while they are doing exercise at home, the built-in heart rate and cardiac rhythm warning function will remind them to take a break, even to take medical treatment. More importantly, the ECG signal can be almost immediately (real time) uploaded by network to the chest pain unit of hospital. The cardiology expert will be aware of the warning at the first moment. This is an important protection to patients' safety of doing rehabilitation sports at home.

This randomized control trial will recruit 80 patients who had myocardial infarction within 6 weeks, and are not able to attend a hospital based cardiac rehabilitation program regularly. All patient will undergo a three-month home exercise program under the instruction provided by the physiatrists and physiotherapists. Forty of them (the remote-care group) will use the intelligent portable remote care system for cardiopulmonary exercise to monitor their exercise intensity and cardiac rhythm during exercise. The other 40 patients (the control group) undertake the exercise program at home without using the remote care system. The efficacy and safety of exercise program will be compared between the two groups.

Detailed Description

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Conditions

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Exercise Capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remote-care

Home exercise monitored by the remote care system

Group Type EXPERIMENTAL

Home exercise

Intervention Type BEHAVIORAL

Daily home exercise for 3 months

Control

Home exercise under expert's instruction

Group Type ACTIVE_COMPARATOR

Home exercise

Intervention Type BEHAVIORAL

Daily home exercise for 3 months

Interventions

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Home exercise

Daily home exercise for 3 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* within 6 weeks after an acute myocardial infarction
* not able to attend a hospital based cardiac rehabilitation program regularly

Exclusion Criteria

* with left ventricular ejection fraction lower than 40%
* history of cardiac arrest
* history of cardiogenic shock, heart failure
* complicated arrhythmia
* abnormal exercise hemodynamics: blood pressure not increased with exercise
* any other physical/psychological condition that hinders the patient's walking ability
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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China Medical University Hospital

Principal Investigators

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Nai-Hsin Meng, M.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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China Medical University Hospital

Taichung, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Nai-Hsin Meng, M.D.

Role: CONTACT

Phone: 886-4-22052121

Email: [email protected]

Facility Contacts

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Nai-Hsin Meng, M.D.

Role: primary

Other Identifiers

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CMU99-NCTU-12

Identifier Type: -

Identifier Source: org_study_id