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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by China Medical University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
China Medical University, China
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01250600
First received: November 26, 2010
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Exercise Capacity
Behavioral: Home exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Application of Intelligent Wireless and Portable Tele-Cardiopulmonary Exercise System on Rehabilitation for Patients With Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Change from baseline in exercise capacity at 3 months [ Time Frame: baseline and after a 3-month exercise program ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: baseline and after a 3-month exercise program ] [ Designated as safety issue: No ]
    Quality of life questionnaires, including SF-36

  • Change from baseline in physical activities at 3 months. [ Time Frame: baseline and after a 3-month exercise program ] [ Designated as safety issue: No ]
    The International Physical Activity Questionnaire


Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote-care
Home exercise monitored by the remote care system
Behavioral: Home exercise
Daily home exercise for 3 months
Active Comparator: Control
Home exercise under expert's instruction
Behavioral: Home exercise
Daily home exercise for 3 months

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250600

Contacts
Contact: Nai-Hsin Meng, M.D. 886-4-22052121 ext 2380 nsmeng@ms13.hinet.net

Locations
Taiwan
China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 404
Contact: Nai-Hsin Meng, M.D.    886-4-22052121 ext 2380    nsmeng@ms13.hinet.net   
Principal Investigator: Nai-Hsin Meng, M.D.         
Sub-Investigator: Pei-Yu Yang, MD, Msc         
Sponsors and Collaborators
China Medical University Hospital
China Medical University, China
Investigators
Principal Investigator: Nai-Hsin Meng, M.D. China Medical University Hospital
  More Information

No publications provided

Responsible Party: Nai-Hsin Meng, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01250600     History of Changes
Other Study ID Numbers: CMU99-NCTU-12
Study First Received: November 26, 2010
Last Updated: November 29, 2010
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014