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

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

Tracking Information

• First Submitted Date: January 2, 2013
• First Posted Date: January 4, 2013
• Last Update Posted Date: January 4, 2013
• Study Start Date: August 2001
• Actual Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2013)

Heart rate variability [ Time Frame: 8 weeks ]

R-R interval difference

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study on Heart Rate Variability in Cardiac Transplant Recipients With Exercise and After Exercise Training
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cardiac Transplant Disorder

Intervention

• Behavioral: Exercise training
  exercise training
• Behavioral: usual care
  received usual medical care after heart transplantation

Study Arms

• Experimental: exercise group
  exercise training
  Intervention: Behavioral: Exercise training
• Active Comparator: Control
  usual care
  Intervention: Behavioral: usual care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 3, 2013): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2003
• Actual Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT01760538
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: National Taiwan University Hospital
• Study Sponsor: National Taiwan University Hospital
• Collaborators: Not Provided

Investigators

• Study Director: Ying-Tai Wu, Doctor; National Taiwan University Hospital

• PRS Account: National Taiwan University Hospital
• Verification Date: November 2012