Study on Heart Rate Variability in Cardiac Transplant Rec... | NCT01760538

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

NCT01760538

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Jan 4, 2013Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Cardiac Transplant Disorder

Interventions

Exercise training
usual care

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2001

Primary Completion Date

Sep 2003Actual

Completion Date

Sep 2003Actual

First Submitted Date

Jan 2, 2013

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2013

Last Update Posted Date

Jan 4, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
exercise group	Experimental	exercise training	Behavioral: Exercise training
Control	Active Comparator	usual care	Behavioral: usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise training	Behavioral	exercise training	exercise group
usual care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rate variability	R-R interval difference	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Exercise capacity	oxygen consumption	8 weeks
Quality of life	This outcome measures how good life the patients have	8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ying-Tai Wu, Doctor	National Taiwan University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
NSC 90-2314-B-002-313
NSC 91-2314-B-002-320