We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755131
First Posted: September 18, 2008
Last Update Posted: February 2, 2010
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.
Information provided by:
Federico II University
Results First Submitted: November 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Basic Science
Condition: Acute Myocardial Infarction
Intervention: Other: Exercise-based Cardiac Rehabilitation program

  Participant Flow
  Hide 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 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
No text entered.

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
  Hide 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
  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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide 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
No text entered.


  More Information
  Hide More Information

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 by ClinicalTrials.gov Identifier (NCT Number):

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
First Submitted: September 17, 2008
First Posted: September 18, 2008
Results First Submitted: November 5, 2009
Results First Posted: January 25, 2010
Last Update Posted: February 2, 2010