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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Transplant Disorder Behavioral: Exercise training Behavioral: usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training
Study Start Date : August 2001
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

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Arms and Interventions
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Arm Intervention/treatment
Experimental: exercise group
exercise training
 Behavioral: Exercise training
exercise training
Active Comparator: Control
usual care
 Behavioral: usual care
received usual medical care after heart transplantation


Outcome Measures
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Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 8 weeks ]
    R-R interval difference


Secondary Outcome Measures :
  1. Exercise capacity [ Time Frame: 8 weeks ]
    oxygen consumption

  2. Quality of life [ Time Frame: 8 weeks ]
    This outcome measures how good life the patients have


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760538


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Ying-Tai Wu, Doctor National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01760538     History of Changes
Other Study ID Numbers: 1913
NSC 90-2314-B-002-313
NSC 91-2314-B-002-320
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: November 2012
Keywords provided by National Taiwan University Hospital:
Cardiac transplant recipients
Heart rate variability
Exercise training