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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High intensity knee-extensor training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring exercise, Knee extensor

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Knee extensor exercise training

    Arm Description

    High intensity aerobic knee-extensor exercise training

    Outcomes

    Primary Outcome Measures

    Peak power

    Secondary Outcome Measures

    Mitochondrial respiration, Vmax

    Full Information

    First Posted
    March 2, 2010
    Last Updated
    August 1, 2016
    Sponsor
    Norwegian University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01079221
    Brief Title
    Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
    Official Title
    Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    exercise, Knee extensor

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Knee extensor exercise training
    Arm Type
    Experimental
    Arm Description
    High intensity aerobic knee-extensor exercise training
    Intervention Type
    Behavioral
    Intervention Name(s)
    High intensity knee-extensor training
    Intervention Description
    High intensity aerobic knee-extensor exercise training, 4x 3 minutes interval training at < 90 % of peak power, 3 days/week for 6 weeks
    Primary Outcome Measure Information:
    Title
    Peak power
    Time Frame
    At inclusion and after 6 weeks of training
    Secondary Outcome Measure Information:
    Title
    Mitochondrial respiration, Vmax
    Time Frame
    At inclusion and after 6 weeks of training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ulrik Wisløff, PhD prof.
    Organizational Affiliation
    Norwegian University of Science and Technology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22408206
    Citation
    Bronstad E, Rognmo O, Tjonna AE, Dedichen HH, Kirkeby-Garstad I, Haberg AK, Ingul CB, Wisloff 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.
    Results Reference
    result

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

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