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Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01079221
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE March 2, 2010
First Posted Date  ICMJE March 3, 2010
Last Update Posted Date August 2, 2016
Study Start Date  ICMJE February 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
Peak power [ Time Frame: At inclusion and after 6 weeks of training ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
Mitochondrial respiration, Vmax [ Time Frame: At inclusion and after 6 weeks of training ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title  ICMJE Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
Brief Summary

COPD patients have a reduced exercise tolerance due to a ventilatory limitation.

Several studies have shown altered skeletal muscle function. The investigator will study the physiological response to knee-extensor exercise in COPD patients.

Detailed Description

Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. However the weak correlation between exercise capacity and FEV1 implies that other factors than reduced pulmonary function contribute to this impairment as well. Several studies have found changes in skeletal muscle, with fibre shift, increased oxidative stress, increased inflammatory cytokines and impaired mitochondrial function, suggesting a lower limb dysfunction.

Numerous exercise studies in COPD patients have shown physiological and physiological benefits of training and endurance training is now regarded as an important part in pulmonary rehabilitation.

In this study we investigate training effects in patients with moderate to severe COPD with special focus on skeletal muscle.

COPD patients will perform high intensity aerobic interval knee-extensor exercise training 3 days/week for six weeks . At baseline and follow-up, muscle oxygen consumption and mitochondrial respiration will be measured.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Behavioral: High intensity knee-extensor training
High intensity aerobic knee-extensor exercise training, 4x 3 minutes interval training at < 90 % of peak power, 3 days/week for 6 weeks
Study Arms  ICMJE Experimental: Knee extensor exercise training
High intensity aerobic knee-extensor exercise training
Intervention: Behavioral: High intensity knee-extensor training
Publications * Brønstad E, Rognmo O, Tjonna AE, Dedichen HH, Kirkeby-Garstad I, Håberg AK, Ingul CB, Wisløff U, Steinshamn S. High-intensity knee extensor training restores skeletal muscle function in COPD patients. Eur Respir J. 2012 Nov;40(5):1130-6. doi: 10.1183/09031936.00193411. Epub 2012 Mar 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2010)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • COPD diagnosis with FEV1<70% exp, FEV1%FVC <70 %
  • Age> 50 years

Exclusion Criteria:

  • Heart failure
  • Symptomatic coronary artery disease
  • Cancer
  • Alcohol and drug abuse
  • Severe mental illness
  • Lower respiratory illness
  • Participation in exercise- or lung rehabilitation program last 3 months
  • pregnancy
  • oral steroid use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01079221
Other Study ID Numbers  ICMJE 42009297
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ulrik Wisløff, PhD prof. Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP