Training Study to Evaluate the Benefit of Exercise for Pa... | NCT00934609

Studies
Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure

NCT00934609

Sponsor

Universität des Saarlandes

Status

Completed

Last Update Posted

Sep 18, 2009Estimated

Enrollment

66Actual

Phase

Not Applicable

Conditions

Dilated Cardiomyopathy
Chronic Heart Failure

Interventions

Endurance training

Countries

Germany

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

Sep 2009

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 7, 2009

First Submission Date that Met QC Criteria

Jul 7, 2009

First Posted Date

Jul 8, 2009Estimated

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

Sep 17, 2009

Last Update Posted Date

Sep 18, 2009Estimated

Name	Class
The German Heart Foundation	OTHER

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

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

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training	Experimental	12 weeks of endurance training on the cycle ergometer under supervision on a physician	Behavioral: Endurance training
Control	No Intervention	Control condition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endurance training	Behavioral	45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks	Training

Measure	Description	Time Frame
Physical capacity

Measure	Description	Time Frame
Left ventricular function
occurence of complications		within study period

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic heart failure NYHA stage 2 and 3

Exclusion Criteria:

Valvular disease
recent decompensation
Other complaints that might interfere with ergometer exercise

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Sports- and Preventive Medicine, Saarland University		Saarbrücken	Saarland	66123	Germany

Condition Browse Module

MeSH Terms

ID	Term
D002311	Cardiomyopathy, Dilated
D009043	Motor Activity
D006333	Heart Failure

Ancestor Terms

ID	Term
D006332	Cardiomegaly
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009202	Cardiomyopathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000076663	Endurance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided