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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:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01760538
First received: January 2, 2013
Last updated: January 3, 2013
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Heart rate variability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    R-R interval difference


Secondary Outcome Measures:
  • Exercise capacity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    oxygen consumption

  • Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 2, 2013
Last Updated: January 3, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Cardiac transplant recipients
Heart rate variability
Exercise training

ClinicalTrials.gov processed this record on May 19, 2013