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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760538
First Posted: January 4, 2013
Last Update Posted: January 4, 2013
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 (Responsible Party):
National Taiwan University Hospital
  Purpose
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 Intervention
Cardiac Transplant Disorder Behavioral: Exercise training Behavioral: usual care

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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


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

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


Enrollment: 30
Study Start Date: August 2001
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
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
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
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Ying-Tai Wu, Doctor National Taiwan University Hospital
  More Information

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 Submitted: January 2, 2013
First Posted: January 4, 2013
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