Study on the Efficacy and Mechanism of Cardiac Rehabilitation for Stem Cell Mobilization and Heart Failure Improvement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154466
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Myocardial Infarction
Intervention: Behavioral: cardiac rehabilitation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This prospective randomised controlled study was approved by the ethics committee of the National Taiwan University Hospital. Between August 2004 and December 2005, 91 postinfarction patients were informed about the trial. Thirty-seven refused to participate and 15 did not meet the inclusion criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Inclusion criteria:a successful primary stenting, a clinically stable course after MI, and no ischemia on exercise testing. Exclusion criteria: effort angina, Af, sustained ventricular arrhythmia, NYHA functional class IV, exercise-limiting diseases, severe pulmonary or renal disease, an implanted pacemaker, or claustrophobia.

Reporting Groups
Post-infarction Training which underwent a 3-month cardiac rehabilitation program
Post-infarction Nontraining in which patients continued their usual lifestyle.
Healthy Controls For comparison of myocardial perfusion and angiogenic cytokines, 19 age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.

Participant Flow:   Overall Study
    Post-infarction Training   Post-infarction Nontraining   Healthy Controls
STARTED   20   19   19 [1] 
COMPLETED   20   19   19 
NOT COMPLETED   0   0   0 
[1] Healthy controls underwent the test of myocardial perfusion only at baseline.

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Postinfarction Training Patients 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
Postinfarction Nontraining Patients 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
Healthy Controls 39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
Total Total of all reporting groups

Baseline Measures
   Postinfarction Training Patients   Postinfarction Nontraining Patients   Healthy Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   19   19   58 
[Units: Participants]
<=18 years   0   0   0   0 
Between 18 and 65 years   20   19   19   58 
>=65 years   0   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 52  (8)   52  (9)   50  (9)   52  (8) 
[Units: Participants]
Female   0   0   0   0 
Male   20   19   19   58 
Region of Enrollment 
[Units: Participants]
Taiwan   20   19   19   58 

  Outcome Measures

1.  Primary:   Myocardial Blood Flow at Baseline and 3-month Follow-up   [ Time Frame: 3 months ]

2.  Secondary:   Angiogenic Cytokines at Baseline and 3-month Follow-up   [ Time Frame: 3 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
First, our trial is small size. Second, these results are applicable only for male patients less than 65 years old with ST-segment elevation MI after successful PCI. Third, the source of angiogenic cytokines cannot be elucidated.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Bai-Chin Lee
Organization: National Taiwan University Hospital
phone: 0223123456 ext 63352

Publications of Results:

Responsible Party: National Taiwan University Hospital Identifier: NCT00154466     History of Changes
Other Study ID Numbers: 9261701248
First Submitted: September 9, 2005
First Posted: September 12, 2005
Results First Submitted: December 6, 2012
Results First Posted: June 26, 2014
Last Update Posted: June 26, 2014