Maximal Leg Press Strength Training Study for Coronary Ar... | NCT00184457

Studies
Maximal Leg Press Strength Training Study for Coronary Artery Disease Patients

NCT00184457

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Heart Failure
Coronary Artery Disease

Interventions

Strength training intervention

Countries

Norway

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 2011

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

Sep 2005

Primary Completion Date

Apr 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Sep 15, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 16, 2005Estimated

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 16, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Name	Class
St. Olavs Hospital	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

Description Module

Brief Summary

Maximal strength training has been shown to increase muscular strength, muscular volume and work economy. An 8 week maximal leg press training regime will be conducted on cardiac heart failure patients to evaluate whether they increase their maximal leg press strength, work economy, serum testosterone and quality of life. The study hypotheses are that:

Aerobic work capacity will increase due to increased work economy, without increases in maximal oxygen uptake.
Strength training will increase serum testosterone.

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

12Actual

Name	Type	Description	Arm Group Labels	Other Names
Strength training intervention	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal leg press strength
Work economy
Serum testosterone
Quality of life

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically diagnosed coronary artery disease
Stable coronary artery disease
1.5 mm depression in ST segment during a cycling strain test
Between 18-70 years of age

Exclusion Criteria:

Unstable coronary artery disease
Other limitations to exercise than coronary artery disease
Participants in other study interventions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Asbjørn Støylen, MD	Norwegian University of Science and Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norwegian University of Science and Technology		Trondheim		7489	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19199203	Result	Karlsen T, Helgerud J, Stoylen A, Lauritsen N, Hoff J. Maximal strength training restores walking mechanical efficiency in heart patients. Int J Sports Med. 2009 May;30(5):337-42. doi: 10.1055/s-0028-1105946. Epub 2009 Feb 6.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia

ID	Term
D006333	Heart Failure
D003324	Coronary Artery Disease