Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00755131
First received: September 17, 2008
Last updated: January 25, 2010
Last verified: December 2009
Results First Received: November 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Basic Science
Condition: Acute Myocardial Infarction
Intervention: Other: Exercise-based Cardiac Rehabilitation program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was a single-center, randomized, controlled study carried out from October 2008 to January 2009 at the Department of Clinical Medicine, Cardiovascular and Immunological Sciences, University of Naples “Federico II”.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Exercise Training Group Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
Control Group Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.

Participant Flow:   Overall Study
    Exercise Training Group     Control Group  
STARTED     37     38  
COMPLETED     37     38  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Exercise Training Group Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program
Control Group Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program.
Total Total of all reporting groups

Baseline Measures
    Exercise Training Group     Control Group     Total  
Number of Participants  
[units: participants]
  37     38     75  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     29     57  
>=65 years     9     9     18  
Age  
[units: years]
Mean ± Standard Deviation
  60.8  ± 7.0     59.5  ± 7.7     60.4  ± 7.5  
Gender  
[units: participants]
     
Female     9     6     15  
Male     28     32     60  
Region of Enrollment  
[units: participants]
     
Italy     37     38     75  



  Outcome Measures
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1.  Primary:   High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months   [ Time Frame: baseline and 6-month follow-up ]

2.  Secondary:   Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months   [ Time Frame: Baseline and 6-month follow-up ]

3.  Other Pre-specified:   Heart Rate Recovery at Baseline and 6 Months   [ Time Frame: baseline and 6 month follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. Carlo Vigorito, Director Cardiac Rehabilitation Unit, Federico II University
Organization: University of Naples Federico II
phone: +39081746 ext 2639
e-mail: vigorito@unina.it


Publications:

Publications automatically indexed to this study:

Responsible Party: Carlo Vigorito, Department of Clinical Medicine, Cardiovascular and Immunological Sciences
ClinicalTrials.gov Identifier: NCT00755131     History of Changes
Other Study ID Numbers: UNINA-15775
Study First Received: September 17, 2008
Results First Received: November 5, 2009
Last Updated: January 25, 2010
Health Authority: Italy: National Institute of Health