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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01079221
Other study ID # 42009297
Secondary ID
Status Completed
Phase N/A
First received March 2, 2010
Last updated August 1, 2016
Start date February 2009
Est. completion date December 2012

Study information

Verified date August 2016
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data ServicesNorway: Ministry of Health and Care ServicesNorway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2012
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

References & Publications (1)

Brønstad E, Rognmo O, Tjonna AE, Dedichen HH, Kirkeby-Garstad I, Håberg AK, Bjørk Ingul C, 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Peak power At inclusion and after 6 weeks of training No
Secondary Mitochondrial respiration, Vmax At inclusion and after 6 weeks of training No
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