Effects of Intelligent Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction
Primary Purpose
Exercise Capacity
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Home exercise
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Capacity
Eligibility Criteria
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
Sites / Locations
- China Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Remote-care
Control
Arm Description
Home exercise monitored by the remote care system
Home exercise under expert's instruction
Outcomes
Primary Outcome Measures
Change from baseline in exercise capacity at 3 months
6-minute walk test and maximum oxygen uptake obtained by a graded exercise test
Secondary Outcome Measures
Change from baseline in quality of life at 3 months.
Quality of life questionnaires, including SF-36
Change from baseline in physical activities at 3 months.
The International Physical Activity Questionnaire
Full Information
NCT ID
NCT01250600
First Posted
November 26, 2010
Last Updated
November 29, 2010
Sponsor
China Medical University Hospital
Collaborators
China Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT01250600
Brief Title
Effects of Intelligent Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction
Official Title
Application of Intelligent Wireless and Portable Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
China Medical University Hospital
Collaborators
China Medical University, China
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Capacity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Remote-care
Arm Type
Experimental
Arm Description
Home exercise monitored by the remote care system
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Home exercise under expert's instruction
Intervention Type
Behavioral
Intervention Name(s)
Home exercise
Intervention Description
Daily home exercise for 3 months
Primary Outcome Measure Information:
Title
Change from baseline in exercise capacity at 3 months
Description
6-minute walk test and maximum oxygen uptake obtained by a graded exercise test
Time Frame
baseline and after a 3-month exercise program
Secondary Outcome Measure Information:
Title
Change from baseline in quality of life at 3 months.
Description
Quality of life questionnaires, including SF-36
Time Frame
baseline and after a 3-month exercise program
Title
Change from baseline in physical activities at 3 months.
Description
The International Physical Activity Questionnaire
Time Frame
baseline and after a 3-month exercise program
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nai-Hsin Meng, M.D.
Phone
886-4-22052121
Ext
2380
Email
nsmeng@ms13.hinet.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nai-Hsin Meng, M.D.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nai-Hsin Meng, M.D.
Phone
886-4-22052121
Ext
2380
Email
nsmeng@ms13.hinet.net
First Name & Middle Initial & Last Name & Degree
Nai-Hsin Meng, M.D.
First Name & Middle Initial & Last Name & Degree
Pei-Yu Yang, MD, Msc
12. IPD Sharing Statement
Learn more about this trial
Effects of Intelligent Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction
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