NCT01760538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
Last Updated

January 4, 2013

Status Verified

November 1, 2012

Enrollment Period

2.1 years

First QC Date

January 2, 2013

Last Update Submit

January 3, 2013

Conditions

Cardiac Transplant Disorder

Keywords

Cardiac transplant recipientsHeart rate variabilityExercise training

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    R-R interval difference

    8 weeks

Secondary Outcomes (2)

  • Exercise capacity

    8 weeks

  • Quality of life

    8 weeks

Study Arms (2)

exercise group

EXPERIMENTAL

exercise training

Behavioral: Exercise training

Control

ACTIVE COMPARATOR

usual care

Behavioral: usual care

Interventions

Exercise trainingBEHAVIORAL

exercise training

exercise group
usual careBEHAVIORAL

received usual medical care after heart transplantation

Control

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Any condition that might affect exercise performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ying-Tai Wu, Doctor

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 4, 2013

Study Start

August 1, 2001

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

January 4, 2013

Record last verified: 2012-11

Locations

TW(1)