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Skeletal Muscle Dysfunction in Heart Failure

Primary Purpose

Heart Failure, Congestive

Status

Unknown status

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

One-knee extension ergometer

About this trial

This is an interventional educational/counseling/training trial for Heart Failure, Congestive

Eligibility Criteria

40 Years - 78 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Coronary Heart Failure Ejection fraction <35% NYHA 2-3 Spirometry FEV1 > 80% Exclusion Criteria: Cardiomyopathy Transplantation candidate Active malignancy Restraining skeletal-muscular disease Claudication in legs Hospitalized last 30 days due to acute ischemic episode Intravenous inotrope or vasodilatating drugs last 14 days prior to inclusion AMI last 8 weeks prior to inclusion Organized training last 4 months Smoking on daily basis last 4 months Creatinin < 150microliters/liter

Sites / Locations

Institute for Experimental Medical ResearchRecruiting
Norwegian School of Sport SciencesRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00156234

First Posted

September 8, 2005

Last Updated

September 8, 2005

Sponsor

Ullevaal University Hospital

Collaborators

Norwegian Health Association, Norwegian School of Sport Sciences, The Research Council of Norway, University of Oslo

1. Study Identification

Unique Protocol Identification Number

NCT00156234

Brief Title

Skeletal Muscle Dysfunction in Heart Failure

Official Title

Training and Congestive Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

March 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Ullevaal University Hospital

Collaborators

Norwegian Health Association, Norwegian School of Sport Sciences, The Research Council of Norway, University of Oslo

4. Oversight

5. Study Description

Brief Summary

Patients suffering from congestive heart failure report reduced exercise capacity. This skeletal muscle dysfunction is also detectable when using small muscle groups which should not put any demand on the heart. We hypothesize that congestive heart failure has systemic effects that causes the skeletal muscle dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Congestive

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

45 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

One-knee extension ergometer

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ole M Sejersted, Professor

Organizational Affiliation

Institute for Experimental Medical Research, Ullevaal University Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Per Kristian B Lunde, Post Doc

Organizational Affiliation

Institute for Experimental Medical Research, Ullevaal University Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ivar Sjaastad, Post Doc

Organizational Affiliation

Institute for Experimental Medical Research, Ullevaal University Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jostein Hallen, Professor

Organizational Affiliation

Norwegian School of Sport Sciences

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Morten Munkvik, Ph.D student

Organizational Affiliation

Institute for Experimental Medical Research, Ullevaal University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tommy A Rehn, Vit.ass.

Organizational Affiliation

Institute for Experimental Medical Research, Ullevaal University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gunnar S Petersen, Ph.D student

Organizational Affiliation

Norwegian School of Sport Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute for Experimental Medical Research

City

Oslo

ZIP/Postal Code

0407

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ole M Sejersted, Professor

Phone

23 01 68 00

Ext

o.m.sejersted@medisin.uio.no

First Name & Middle Initial & Last Name & Degree

Per Kristian B Lunde, Post Doc

Phone

23 01 68 35

Ext

p.k.lunde@medisin.uio.no

Facility Name

Norwegian School of Sport Sciences

City

Oslo

ZIP/Postal Code

0806

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jostein Hallén, Professor

Phone

23 26 23 14

Ext

jostein.hallen@nih.no

First Name & Middle Initial & Last Name & Degree

Gunnar Petersen, Ph.D student

gunnar.petersen@nih.no

First Name & Middle Initial & Last Name & Degree

Jostein Hallen, Professor

12. IPD Sharing Statement

Citations:

PubMed Identifier

19996998

Citation

Munkvik M, Rehn TA, Slettalokken G, Hasic A, Hallen J, Sjaastad I, Sejersted OM, Lunde PK. Training effects on skeletal muscle calcium handling in human chronic heart failure. Med Sci Sports Exerc. 2010 May;42(5):847-55. doi: 10.1249/MSS.0b013e3181c29ec1.

Results Reference

derived

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Skeletal Muscle Dysfunction in Heart Failure

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