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Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training

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ClinicalTrials.gov Identifier: NCT01760538
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date January 4, 2013
Study Start Date  ICMJE August 2001
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Heart rate variability [ Time Frame: 8 weeks ]
R-R interval difference
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • Exercise capacity [ Time Frame: 8 weeks ]
    oxygen consumption
  • Quality of life [ Time Frame: 8 weeks ]
    This outcome measures how good life the patients have
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training
Official Title  ICMJE Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training
Brief Summary The purpose of the study was to investigate the changes on heart rate variability, exercise capacity, activities of daily living, and quality of life after aerobic exercise training in cardiac transplant recipients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Transplant Disorder
Intervention  ICMJE
  • Behavioral: Exercise training
    exercise training
  • Behavioral: usual care
    received usual medical care after heart transplantation
Study Arms  ICMJE
  • Experimental: exercise group
    exercise training
    Intervention: Behavioral: Exercise training
  • Active Comparator: Control
    usual care
    Intervention: Behavioral: usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2013)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2003
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Heart transplant recipients with stable post operation condition
  • Age between 20-70 years
  • No acute or severe chronic rejection

Exclusion Criteria:

  • Any condition that might affect exercise performance
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760538
Other Study ID Numbers  ICMJE 1913
NSC 90-2314-B-002-313
NSC 91-2314-B-002-320
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ying-Tai Wu, Doctor National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP